Podcasts about drug evaluation

New England Journal of Medicine Interviews

Play Episode Listen Later Jan 10, 2025 25:24

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni's surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA's decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway': https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/

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NEJM Interview: Bindu Kanapuru on the FDA's new expedited withdrawal procedure for accelerated approvals.

Play Episode Listen Later Dec 11, 2024 9:12

Bindu Kanapuru is a hematologist–oncologist physician in the Office of Oncologic Diseases at the FDA's Center for Drug Evaluation and Research. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the Journal. B. Kanapuru and Others. Autopsy of a Drug Withdrawal — The Case of Melphalan Flufenamide. N Engl J Med 2024;391:2177-2179.

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27: PRO Research Is Key for a Patient-Focused Oncology Pharmacology Career: With D. Ross Camidge, MD, PhD, and Jeanne Fourie Zirkelbach, PhD

How This Is Building Me

Play Episode Listen Later Oct 9, 2024 60:48

In this episode, Dr Camidge sits down with Jeanne Fourie Zirkelbach, PhD, a clinical pharmacologist in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the FDA. Drs Camidge and Zirkelbach discuss how Zirkelbach got her start in the pharmacokinetics field; her involvement with Project Optimus, an initiative by the FDA's Oncology Center of Excellence that works to reform dose-optimization and -selection paradigms in oncology drug development; and how her research with patient-reported outcomes emphasizes the importance of keeping patient needs, preferences, and experiences at the forefront of drug development to minimize the effects of cancer treatment on quality of life.

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Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

Combinate Podcast - Med Device and Pharma

Play Episode Listen Later Jul 17, 2024 40:28

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor's degree in Bioengineering from the University of California, Berkeley, his doctorate and master's degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.

Drug Fix: Novel Clinical Trial Reg Problems, NIH Drug ‘Access Plans', Good Ole Days Of Woodcock

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Play Episode Listen Later May 24, 2024 23:09

Pink Sheet editors discuss the US FDA's consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA's Center for Drug Evaluation and Research (15:35). More On These Topics From The Pink Sheet ‘Antiquated' Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution' In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Access Plan' Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach

Dr. Kevin Bugin, Ph.D. - Deputy Director of Operations, Office of New Drugs, CDER, U.S. FDA - Clinical Trial Innovation To Improve The Efficiency And Effectiveness Of Drug Development

Progress, Potential, and Possibilities

Play Episode Listen Later May 22, 2024 55:29

Send us a Text Message.Dr. Kevin Bugin, Ph.D. is Deputy Director of Operations in the Office of New Drugs ( OND - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs ) in FDA's Center for Drug Evaluation and Research ( CDER - https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ), where among his many responsibilities he serves as lead for the Center for Clinical Trial Innovation ( C3TI - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti ), a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct. Prior to his current role, from May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government's HHS and DOD operation formerly known as Operation Warp Speed. Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development. Dr. Bugin joined the FDA in 2008 in the Office of Business Process Support, then joined the Division of Gastroenterology and Inborn Errors Products within OND as a Regulatory Health Project Manager in 2010, and as the Chief of Project Management from 2015 to 2017. From 2017 until 2020, he served as the Director of Special Programs and the lead of CDER's New Drugs Regulatory Program Modernization. Prior to joining the FDA, Dr. Bugin held roles in multiple areas and phases of drug development, including discovery (molecular biology) at the Virginia Bioinformatics Institute, translational research and technology transfer at the National Institute of Health's Office of Technology Transfer, safety and pharmacovigilance with NIH's National Cancer Institute's Cancer Therapy Evaluation Program, and regulatory affairs and quality assurance at Amarex Clinical Research. Dr. Bugin received a BS in Biology and Chemistry from Virginia Tech in 2005, an MS in Biotechnology from American University in 2006, and a PhD in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in US regulatory affairs (RAC) and participates in numerous policy and regulatory science program working groups across the FDA.Support the Show.

The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein | Q&A with FDA

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Play Episode Listen Later Mar 19, 2024 16:27

Dr. Theresa Michele, MD from the Office of Nonprescription Drugs within the FDA's Center for Drug Evaluation and Research and Dr. Ilisa Bernstein, PharmD Senior Vice President for Practice, Policy and Partnerships from the American Pharmacists Association, APhA, are our guests on this episode of "Q&A with FDA" Q&A with FDA provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA's Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions but never asked. C.E. for this episode here: https://www.fda.gov/drugs/news-events-human-drugs/qa-fda-podcastRSS feed for Q&A with FDA

A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska | Q&A with FDA

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Play Episode Listen Later Nov 15, 2023 9:13

The rates of alcohol use disorder increased significantly since the onset of COVID-19, making this a major public health issue, though it's not discussed as frequently as opioid overdoses. Over 140,000 Americans die from the effects of alcohol in an average year (more than from drug overdoses). Ten percent of Americans over the age of 12 have Alcohol Use Disorder. And according to the 2023 Alcohol Abuse Statistics, 60% of Americans increased their alcohol consumption during COVID-19 lockdowns. In this podcast, we are joined by Dr. Iilun Murphy, Director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research (CDER), and returning is Dr. Marta Sokolowska, CDER's Deputy Center Director for Substance Use and Behavioral Health to discuss the recent first generic approval to Vivitrol, a one-month extended-release injectable naltrexone that is used to help people recovering from opioid or alcohol dependence.

China Biotech Podcast (Chinese language) - October 2023

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Play Episode Listen Later Oct 31, 2023 27:10

In this Chinese-language podcast, Brian Yang and Dexter Yan discuss China biotech topics including the annual IND and NDA report from Center for Drug Evaluation, ESMO's China data and Shanghai International Biotech Industry Week. https://scrip.citeline.com/SC149259/Chinese-Language-Podcast-ESMO-China-Data-Annual-CDE-Report-Shanghai-Biotech-Week

Navigating the World of Online Pharmacies with CDR Lysette Deshields | Q&A with FDA

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Play Episode Listen Later Oct 10, 2023 9:42

According to the National Association of Boards of Pharmacy, for the past 10 years, industry experts have consistently estimated that, at any given time, there are between 30,000 and 40,000 active illegal online pharmacies. Today, we are joined by Commander Lysette Deshields, an FDA officer in the United States Public Health Service Commissioned Corps. CDR Deshields is a Regulatory Officer in the Supply Chain Security Branch in the Office of Drug Security, Integrity and Response, Office of Compliance within the FDA's Center for Drug Evaluation and Research. She will be discussing FDA's BeSafeRx campaign, a national initiative to educate consumers and health care professionals about the potential dangers of buying medicine from unsafe online pharmacies, along with identifying safe online pharmacies so that consumers can make more informed decisions when purchasing prescription medicine online, and tools that healthcare professionals can use to guide patients.

Interview with CDR Stephen Chang, PharmD, MPH - Public Health Pharmacist

Pharmacist's Voice

Play Episode Listen Later Aug 25, 2023 52:53

My guest today is CDR Stephen Chang. He's a pharmacist and an Officer in the United States Public Health Service Commissioned Corps. He's an advocate for public health, and during our interview, we discuss how he got from pharmacy school to working for the FDA, settings he's worked in, roles he's served, deployments he has been on, what he thought he would be doing upon graduation when he was just a pharmacy student, and advice for students and pharmacists who are considering their career options. If you're interested in a career in public health, you need to listen to our conversation! Thank you for listening to episode 239 of The Pharmacist's Voice ® Podcast! To read the FULL show notes, visit https://www.thepharmacistsvoice.com/podcast. Select episode 239. Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out! Apple Podcasts https://apple.co/42yqXOG Google Podcasts https://bit.ly/3J19bws Spotify https://spoti.fi/3qAk3uY Amazon/Audible https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt BIO (August 2023) CDR Stephen Chang, PharmD, MPH, currently is a Senior Clinical Policy Advisor at the U.S. Food and Drug Administration (FDA), Centers for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Immediate Office, Post Market Programs and works from San Francisco, CA. He earned his Doctor of Pharmacy (PharmD) from the Philadelphia College of Pharmacy, University of the Sciences in 2008, and his Master of Public Health from the University of Washington in Seattle in 2015. He also completed a PRESCIENT Postdoctoral Fellowship at the University of California, San Francisco. CDR Chang has a broad range of professional certifications and training in the areas of executive management and leadership, pharmacy-based immunization delivery, and emergency preparedness, epidemiology, biostatistics, translational/precision health, data science. He has numerous research publications and speaker engagements as well as professional honors and awards. As a Senior Clinical Policy Advisor, CDR Chang serves as an expert and resource for Office and Center staff and Management within the Centers for Devices and Radiological Health (CDRH). This support includes providing expertise, direction, and feedback on policies, procedures, and program support on all aspects of regulatory and scientific policy to the seven Offices of Health Technology, Office of Regulatory Programs and Office of Clinical Evidence pertaining to the collection and use of Post Market data related to medical device use and performance. Of his 15-year career in federal service and in the United States Public Health Service, he most recently served as an Associate Director in the Division of Hepatology and Nutrition, Office of New Drugs (OND), Centers for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration and as a Senior Medicaid Enterprise Systems State Officer at the Centers for Medicare and Medicaid Services (CMS). Previously, he also served as an outpatient pharmacist in the Federal Bureau of Prisons (BOP).

FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska | Q&A with FDA

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Play Episode Listen Later Jul 24, 2023 12:12

In this episode of Q&A with FDA, we hear from Dr. Marta Sokolowska, Deputy Center Director for Substance Use and Behavioral Health in FDA's Center for Drug Evaluation and Research, discuss the Agency's vision as it relates to encouraging harm reduction, including expanding availability and access to lifesaving overdose reversal products. Dr. Sokolowska delves into the impacts of the recent approvals of nonprescription naloxone nasal spray as well as prescription nalmefene nasal spray, another medication for opioid overdose.

The FDA ponders whether artificial intelligence can help with drug approval

Federal Drive with Tom Temin

Play Episode Listen Later Jul 3, 2023 18:46

Artificial intelligence seems to be overturning every part of life. How about this one: AI and its country cousin, machine learning, working together to develop new drugs. To see how AI can help and what some of the risks might be, Federal Drive Host Tom Temin spoke with the Food and Drug Administration's Associate Director for Policy Analysis, within the Center for Drug Evaluation and Research, Dr. Tala Fakhouri. Learn more about your ad choices. Visit podcastchoices.com/adchoicesSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

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The FDA ponders whether artificial intelligence can help with drug approval

Federal Drive with Tom Temin

Play Episode Listen Later Jul 3, 2023 18:46

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Food Safety Talk 282: The Fabulous Ms. Mertzel

Food Safety Talk

Play Episode Listen Later Jun 2, 2023 101:12

Urban Dictionary: mann's assumptionThe Who - Won't Get Fooled Again - YouTubeTalking Heads - Once in a Lifetime (Official Video) - YouTubeWiFi Networking Equipment for Home & Business | TP-LinkFood Safety TalkWatch - AppleNoom: Stop dieting. Get lifelong results.White House Plumbers | Official Website for the HBO Series | HBO.comThe Food Section | Hanna Raskin | SubstackCoronation of Charles III and Camilla - WikipediaIAFP Annual Meeting - International Association for Food ProtectionAmerican Association for Agricultural Education - 2023 National Conference | Raleigh, NCSeaman A. Knapp - WikipediaRutgers Law Cannabis CertificateSanitize vs. Disinfect: Know the Difference2023 Biennial Meeting | Conference for Food Protection | Conference for Food ProtectionReport - Disinfectant Committee (DC) | Council III | 2023 Biennial Meeting | Conference for Food Protection | Conference for Food Protection‎Disinfectant Committee Guidance DocumentTajah Blackburn - United States Environmental Protec… | ZoomInfoCenter for Drug Evaluation and Research | CDER | FDAThe Battle Over Refrigerating Butter: ‘Enough Is Enough'Butter with Olive Oil and Sea Salt | Land O'Lakes41: Butter at Room Temperature — Risky or Not?quixotic pronunciation459. AI-Generated Recipes — Risky or Not?Survival of acid adapted and non-acid adapted Salmonella Typhimurium in pasteurized orange juice and yogurt under different storage temperatures - Avelino Álvarez-Ordóñez, Lorena Valdés, Ana Bernardo, Miguel Prieto, Mercedes López, 2013449. Pepper Mill Over a Pot — Risky or Not?Multistate Outbreak of Salmonella Thompson Infections Linked to Seafood Exposure — United States, 2021 | MMWR

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UHC Prior Authorization Changes

Healthcare Policy Pop

Play Episode Listen Later Jun 1, 2023 5:25

Dr. Bruce Hennessy, a gastroenterologist with the American Society for Gastrointestinal Endoscopy, discusses UnitedHealthcare's decision to require new prior authorization for 61 procedures, including colonoscopies. In response to provider and patient concerns, UHC has amended its prior authorization requirements. The Medicaid work requirement has been stripped from the debt ceiling negotiations bill; Valerie Jensen, Associate Director for Drug Shortages in the Center for Drug Evaluation and Research at the FDA, outlines the challenges and potential solutions to the ongoing drug shortages; and the Consumer Product Safety Commission recently released some new stock photos that include people with physical disabilities. UnitedHealth backs off contentious prior authorization plan UnitedHealthcare Letter FDA Report: Drug Shortages NPR News Article: People with disabilities aren't often seen in stock photos. The CPSC is changing that

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The end of ACA's PrEP coverage, Gohibic COVID-19 EUA, Makena withdrawn, and more!

Loving Liberty Radio Network

Play Episode Listen Later Apr 7, 2023 4:33

This week on Pharm5: Cost Plus Drug Co. adds Invokana products Gohibic (vilobelimab) EUA for COVID-19 Makena (hydroxyprogesterone caproate injection) withdrawn from market APL treatment oral tretinoin shortage Federal judge strikes down ACA's OCP and PrEP coverage Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Mark Cuban CostPlus Drug Company - Medications. http://bit.ly/3KjKYS5. Accessed April 6, 2023. Invokana® (canagliflozin) affordability. Janssen CarePath for Healthcare Professionals. http://bit.ly/3nWANLm. Published October 18, 2022. Accessed April 6, 2023. Center for Drug Evaluation and Research. FDA authorizes Gohibic (vilobelimab) injection. U.S. Food and Drug Administration. http://bit.ly/3nWDsVm. Published April 4, 2023. Accessed April 6, 2023. Gohibic [highlights of emergency use authorization]. Jena, Germany: InflaRx GmbH. Published April 2023. Accessed April 6, 2023. FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena. U.S. Food and Drug Administration. http://bit.ly/3ZMOY35. Published April 6, 2023. Accessed April 6, 2023. Drug shortage detail: Tretinoin capsules. ASHP. https://bit.ly/3KhQ2pT. Published March 20, 2023. Accessed April 6, 2023. Treatment of acute promyelocytic leukemia (APL). American Cancer Society. http://bit.ly/3mb3Nif. Accessed April 6, 2023. Cingam SR, Koshy NV. Acute Promyelocytic Leukemia. National Center for Biotechnology Information. http://bit.ly/3nGw5RV. Accessed April 6, 2023. Phillips C. Help Desk for Oncologists Treating People with a Rare Leukemia Pays Big Dividends. National Cancer Institute. http://bit.ly/40EtxT3. Published February 2, 2023. Accessed April 6, 2023. Braidwood Management, Inc., et al. v. Xavier Becerra, et al. Civil Action No. 4:20-cv-00283-O. Supreme Court of Texas, 2022. Accessed April 6, 2023. Judge strikes down Obamacare provisions requiring insurers cover some preventive care services. NBCNews.com. https://bit.ly/3MncZKV. Published March 30, 2023. Accessed April 6, 2023. Burwell v. Hobby Lobby and birth control. Planned Parenthood Action Fund. http://bit.ly/419fPaq. Accessed April 6, 2023. Stolberg SG, Abelson R. Federal judge strikes down Obamacare requirement for free preventive care. The New York Times. http://bit.ly/3nSSAU1. Published March 30, 2023. Accessed April 6, 2023.

03-20-2023 Liberty RoundTable with Sam Bushman

Play Episode Listen Later Mar 28, 2023 109:40

Hour 1 * Guest: Dr. Scott Bradley, Founder and Chairman of the Constitution Commemoration Foundation and the author of the book and DVD/CD lecture series “To Preserve the Nation.” In the Tradition of the Founding Fathers – FreedomsRisingSun.com * Sam and the Good Dr. Discuss Constitutional Currency, AKA ‘Honest Money'! * Fauci, others suppressed Brit recommendation to use ivermectin against COVID – Conclusion called for ‘immediate' approval for use – WND.com * Testimonials arose about how it was effective, even though federal officials, celebrities and others condemned it. They publicly ridiculed those who would use a “horse paste,” even though that was only one form of ivermectin. * The Asahi Shimbun, Kowa Co., the huge Japanese pharmaceutical company, confirmed ivermectin proved an “antiviral effect” against Omicron and other coronavirus variants. * a new report by Emmy Award-winning investigative journalist Sharyl Attkisson reveals Anthony Fauci, and others, suppressed a recommendation at the outset of the pandemic that Ivermectin be used against the killer. * A leading British physician and World Council for Health co-founder Dr. Tess Lawrie, who is director and founder of a doctors' organization called the British Ivermectin Recommendation Development Group (BIRD), emailed 31 Food and Drug Administration (FDA) officials, including the Director of the Offfice of New Drugs in the Center for Drug Evaluation and Research Peter Stein; Center for Biologics Evaluation and Research Director Peter Marks; and then-Acting FDA Commissioner Janet Woodcock; and copying several leading foreign medical figures, with an email titled ‘URGENT: The BIRD meeting and recommendation on COVID-19 prevention and treatment.'” * Lawrie's cover letter states: ‘BIRD panel conclusions are that ivermectin should be approved immediately for prevention and treatment of Covid-19:'” – The British Ivermectin Recommendation Development Panel recommends Ivermectin for the prevention and treatment of Covid-19 to reduce morbidity and mortality associated with Covid-19 infection. * “Rather than educate the public about the supposed reasons for their rejection of the Ivermectin-use recommendation, the FDA, NIH, and Fauci's former agency have blacked out their responses in these documents,” explained Judicial Watch President Tom Fitton. Hour 2 * Guest: Lowell Nelson – CampaignForLiberty.org, RonPaulInstitute.org * 3 Years to Slow The Spread: Covid hysteria and the creation of a never-ending crisis – Jordan Schachtel. * A letter from John Adams to Abigail: “Liberty once lost is lost forever. When the People once surrender their share in the Legislature, and their Right of defending the Limitations upon the Government, and of resisting every Encroachment upon them, they can never regain it.” * Ron Paul Challenged the Coronavirus Tyranny from the Beginning – Adam Dick. * Covid, Courage, and Cowardice – Jordan Schachtel. * “How did you behave in the face of this public panic?” * Jordan writes, “Courage is unique because it is almost impossible to be courageous and popular at the same time. If courage were popular, it wouldn't be brave. If courage was common, it wouldn't be courageous.” * Unsound Banking: Why Most of the World's Banks Are Headed for Collapse – Doug Casey, LewRockwell.com * Bank deposits–until quite recently–were of two kinds: time deposits and demand deposits. --- Support this podcast: https://podcasters.spotify.com/pod/show/loving-liberty/support

Radio Show Hour 1 – 03/20/2023

Liberty Roundtable Podcast

Play Episode Listen Later Mar 20, 2023 54:50

* Guest: Dr. Scott Bradley, Founder and Chairman of the Constitution Commemoration Foundation and the author of the book and DVD/CD lecture series “To Preserve the Nation.” In the Tradition of the Founding Fathers - FreedomsRisingSun.com * Sam and the Good Dr. Discuss Constitutional Currency, AKA 'Honest Money'! * Fauci, others suppressed Brit recommendation to use ivermectin against COVID - Conclusion called for 'immediate' approval for use - WND.com * Testimonials arose about how it was effective, even though federal officials, celebrities and others condemned it. They publicly ridiculed those who would use a "horse paste," even though that was only one form of ivermectin. * The Asahi Shimbun, Kowa Co., the huge Japanese pharmaceutical company, confirmed ivermectin proved an "antiviral effect" against Omicron and other coronavirus variants. * a new report by Emmy Award-winning investigative journalist Sharyl Attkisson reveals Anthony Fauci, and others, suppressed a recommendation at the outset of the pandemic that Ivermectin be used against the killer. * A leading British physician and World Council for Health co-founder Dr. Tess Lawrie, who is director and founder of a doctors' organization called the British Ivermectin Recommendation Development Group (BIRD), emailed 31 Food and Drug Administration (FDA) officials, including the Director of the Offfice of New Drugs in the Center for Drug Evaluation and Research Peter Stein; Center for Biologics Evaluation and Research Director Peter Marks; and then-Acting FDA Commissioner Janet Woodcock; and copying several leading foreign medical figures, with an email titled 'URGENT: The BIRD meeting and recommendation on COVID-19 prevention and treatment.'" * Lawrie's cover letter states: 'BIRD panel conclusions are that ivermectin should be approved immediately for prevention and treatment of Covid-19:'" - The British Ivermectin Recommendation Development Panel recommends Ivermectin for the prevention and treatment of Covid-19 to reduce morbidity and mortality associated with Covid-19 infection. * "Rather than educate the public about the supposed reasons for their rejection of the Ivermectin-use recommendation, the FDA, NIH, and Fauci's former agency have blacked out their responses in these documents," explained Judicial Watch President Tom Fitton.

Novo insulin pricing, potential drug shortages, Match Day results, and more!

Play Episode Listen Later Mar 17, 2023 4:55

This week on Pharm5: Novo Nordisk insulin price cuts Akorn Pharma closing, potential drug shortages Zavzpret (zavegepant) migraine nasal spray Daybue (trofinetide) for Rett Syndrome 2023 Match Results Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024. Novo Nordisk. http://bit.ly/42hziHz. Accessed March 16, 2023. Lilly cuts insulin prices by 70% and caps patient insulin out-of-pocket costs at $35 per month. Eli Lilly and Company. https://bit.ly/3ZQXVcf. Published March 1, 2023. Accessed March 16, 2023. Murphy T. Novo Nordisk plans price cuts for several insulins. AP NEWS. http://bit.ly/3JNzgjz. Published March 14, 2023. Accessed March 16, 2023. Kekatos M, Bakshi N, Coburn J. Nationwide shortage of asthma medication albuterol could worsen in hospitals. ABC News. https://bit.ly/3JfD1wA. Published March 9, 2023. Accessed March 16, 2023. Supply chain disruption due to manufacturer closure: Akorn Pharmaceuticals ceases operations. End Drug Shortages Alliance. https://bit.ly/3JqLZHi. Published March 7, 2023. Accessed March 16, 2023. Pfizer's Zavzpret™ (zavegepant) Migraine Nasal Spray Receives FDA Approval. Pfizer. http://bit.ly/42kQJag. Published March 10, 2023. Accessed March 16, 2023. Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. The Lancet Neurology. 2023;22(3):209-217. doi:10.1016/s1474-4422(22)00517-8 Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective and well tolerated for the acute treatment of migraine: results of a multicenter study. Neurology. 1995;45(8 Suppl 7):S10-S14. Center for Drug Evaluation and Research. FDA approves first treatment for Rett syndrome. U.S. Food and Drug Administration. http://bit.ly/3TjSD6U. Accessed March 16, 2023. Aislinn Antrim E. FDA approves Trofinetide for treatment of Rett syndrome in adult, pediatric patients. Pharmacy Times. http://bit.ly/40fK3bq. Published March 13, 2023. Accessed March 16, 2023. ASHP match statistics. ASHP Match | Statistics of the Match. http://bit.ly/42e4Ga1. Published March 15, 2023. Accessed March 16, 2023. Schedule of dates. ASHP Match | Schedule. https://bit.ly/3I8MJA7. Published March 15, 2023. Accessed March 16, 2023.

"Pharmacist shortage," GoodRx in hot water, COVID updates, and more!

The Oncology Nursing Podcast

Play Episode Listen Later Feb 3, 2023 4:23

This week on Pharm5: Walmart, CVS Claim Pharmacist Shortage Changes to Paxlovid, Lagevrio, and COVID vaccines EzriCare eyedrops linked to bacterial outbreak New FDA approvals: Jayprica, Orserdu, Jesduvroq GoodRx sells health info to advertisers Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Valinsky J. CVS and Walmart Cut Pharmacy Hours, close some locations earlier, citing staffing shortage | CNN business. CNN. http://bit.ly/3RpgS2F. Published January 27, 2023. Accessed February 2, 2023. Keagy J. American Pharmacists Association on move to cut pharmacy hours. American Pharmacists Association. http://bit.ly/3JB0v0Q. Published January 30, 2023. Accessed February 2, 2023. Paxlovid, Lagevrio prescriptions no longer need a positive COVID-19 test. Becker's Hospital Review. http://bit.ly/3DC3Jh3. Published February 1, 2023. Accessed February 2, 2023. Fact sheet for healthcare providers: emergency use authorization for Paxlovid. New York, NY: Pfizer. https://bit.ly/3RvXNvO. Revised February 1, 2023. Accessed February 2, 2023. Fact sheet for healthcare providers: emergency use authorization for Lagevrio (molnupiravir) capsules). Rahway, NJ: Merck & Co. https://bit.ly/3HsLo72. Revised February 1, 2023. Accessed February 2, 2023. Bulloch M. FDA Advisory Committee vote to simplify covid-19 regimen. Pharmacy Times. http://bit.ly/3jweY3t. Published February 1, 2023. Accessed February 2, 2023. O'Mary L. Bacterial outbreak linked to EzriCare eyedrops: CDC. Medscape. http://bit.ly/3l3tOz9. Published February 1, 2023. Accessed February 2, 2023. Update: Multistate Cluster of VIM- and GES-producing Carbapenem resistant Pseudomonas aeruginosa associated with Artificial Tears. https://bit.ly/3DDHrey. Published January 20, 2023. Accessed February 2, 2023. Center for Drug Evaluation and Research. Novel drug approvals for 2023. U.S. Food and Drug Administration. http://bit.ly/3wO6ckC. Accessed February 2, 2023. Pagliarulo N. FDA approves cancer drugs from Lilly, Menarini. BioPharma Dive. http://bit.ly/3DEgnfc. Published January 30, 2023. Accessed February 2, 2023. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. U.S. Food and Drug Administration. http://bit.ly/3RsL64E. Accessed February 2, 2023. FTC enforcement action to Bar Goodrx from sharing consumers' sensitive health info for advertising. Federal Trade Commission. http://bit.ly/3l50F6C. Published February 1, 2023. Accessed February 2, 2023.

Episode 242: Oncology Pharmacology 2023: Today's Treatments and Tomorrow's Breakthroughs

Play Episode Listen Later Jan 13, 2023 53:01

“It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events,” Teresa Knoop, MSN, RN, AOCN®, nurse consultant in Nashville, TN, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS, during a conversation about the latest updates and approvals in oncology pharmacology. You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 1 contact hour of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by January 13, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Participants will report an increase in knowledge related to the latest updates and approvals in oncology pharmacology. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast Episode 126: Oncology Clinical Trials and Drug Development ONS Voice articles: S. Food and Drug Administration (FDA) updates Drug reference sheets Predictive and Diagnostic Biomarkers: Identifying Variants Helps Providers Tailor Cancer Surveillance Plans and Treatment Selection Help Patients Understand Biomarker Test Results and Clinical Trials Options Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients ONS Biomarker Database ONS Genomics and Precision Oncology Learning Library ONS Immuno-Oncology Learning Library ONS Oral Anticancer Medication Learning Library ONS Biosimilars Learning Library ONS Seal of Approval Library Oral Chemotherapy Education Sheets Intravenous Cancer Treatment Education Sheets Clinical Journal of Oncology Nursing article: Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars FDA resources: Drug development and approval process Oncology/hematologic malignancies approval notifications Ongoing cancer accelerated approvals Verified clinical benefit cancer accelerated approvals Withdrawn cancer accelerated approvals Project Renewal Biosimilars review and approval Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) Project Livin' Label Oncology Center of Excellence To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “Full approval through the Center for Drug Evaluation and Research (CDER) and FDA means that those drugs have gone through the laboratory testing, human clinical trial testing, and very extensive clinical trials to make sure that they are effective and that the benefits of those drugs outweigh the risks.” TS 02:28 “In 1992, CDER established a new program that would help these drugs get expedited, particularly in life-threatening or serious diseases like cancer. So they established an accelerated approval pathway for these promising therapies. They were hoping to shorten that period of time, and a number of our cancer-fighting drugs have come onto the market through this accelerated approval pathway.” TS 04:29 “When a drug gets an FDA approval, whether it be accelerated or final, then typically they get approved for one, possibly two indications on that first approval. But there are clinical trials ongoing in other diseases and in other indications. So we will then see drugs—after those clinical trials are conducted—taken to CDER for approval for that new indication.” TS 24:02 “The exciting thing for our patients is that new indications often treat more advanced cancers in which you discover a biomarker and could give patients potential treatment options when other options may have been exhausted.” TS 27:43 “It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events. Many of these drugs are designed so patients have to stay on them for extended periods of time, or at least they get the greatest benefit by staying on it for extended periods of time. Our patient education is key in helping patients do that.” TS 34:50 “In 2023, I think we will continue to see many new drugs that are approved. We will see new indications. I think particularly we will continue to see cellular therapy agents developed—we'll see them gain new indications. I would be willing to forecast that we're going to see more and more of specific immunomodulatory drugs or those antibody drug conjugates—all of those drugs that are designed to treat the cancer in a couple of different ways.” TS 37:29

Practical Significance | Episode 25: Meet the New ASA President, Dionne Price

Practical Significance

Play Episode Listen Later Dec 28, 2022 18:43

Practical Significance kicks off the new year with its January tradition of featuring the new ASA president. Co-hosts Donna and Ron welcome to the show Dionne Price, the 118th president of the American Statistical Association. Dionne—who is the deputy director of the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration—shares aspects of her “day” job and her goals for the year ahead. Listen to how an internship sparked her passion for biostatistics and how she puts the FDA and ASA missions ... The post Practical Significance | Episode 25: Meet the New ASA President, Dionne Price first appeared on Amstat News.

research office price practical fda significance drug administration us food biostatistics american statistical association drug evaluation translational sciences

COVID and monkeypox vaccines, PCAT retirement, and new FDA approvals!

Play Episode Listen Later Dec 9, 2022 4:11

This week on Pharm5: Bivalent booster for kids Jynneos protects against monkeypox Dexcom G7 approved for diabetes Rezlidhia (olutasidenib) approved for AML PCAT retirement in 2024 Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) covid-19 vaccines for children down to 6 months of age. U.S. Food and Drug Administration. https://bit.ly/3UIOuIP. Accessed December 8, 2022. Webinar November 29, 2022 - flu, RSV, COVID-19 and other respiratory threats this fall and Winter. Centers for Disease Control and Prevention. http://bit.ly/3Bf21AX. Published November 16, 2022. Accessed December 8, 2022. Reduced risk for Mpox after receipt of 1 or 2 doses of JYNNEOS vaccine compared with risk among unvaccinated persons - 43 U.S. jurisdictions, July 31–October 1, 2022. Centers for Disease Control and Prevention. https://bit.ly/3FzvTdL. Published December 8, 2022. Accessed December 8, 2022. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed December 8, 2022. Center for Drug Evaluation and Research. FDA approves Olutasidenib. U.S. Food and Drug Administration. https://bit.ly/3W2vSo5. Accessed December 8, 2022. Pharmcas Community. Retirement of the Pharmacy College Admission Test (PCAT). https://bit.ly/3Y9EomW. Published December 6, 2022. Accessed December 8, 2022.

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Tamiflu availability, ADHD medications & CVD, no more mAbs for COVID, and more!

director technology office draft md excellence mobile fda guidance devices assistant directors clinical trials digital health pharmd drug evaluation

Play Episode Listen Later Dec 2, 2022 3:41

This week on Pharm5: Tamiflu backorder ADHD medications & CVD risk Paxlovid dispensing guidance EUA pulled for last remaining COVID-19 monoclonal antibody ASHP Midyear Meeting Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Current drug shortages. ASHP. https://bit.ly/3Fk0Keo. Accessed December 1, 2022. Center for Drug Evaluation and Research. Drug shortages. U.S. Food and Drug Administration. https://bit.ly/3B2DGhC. Accessed December 1, 2022. Weekly U.S. Influenza Surveillance Report. Centers for Disease Control and Prevention. https://bit.ly/3gQ77MW. Published November 28, 2022. Accessed December 1, 2022. Zhang L, Yao H, Li L, et al. Risk of cardiovascular diseases associated with medications used in attention-deficit/hyperactivity disorder. JAMA Network Open. 2022;5(11). doi:10.1001/jamanetworkopen.2022.43597 HQ APhA. APhA has created a pharmacist decision-making support tool for paxlovid. use it in your practices to help assess whether a prescription for Paxlovid is appropriate. Twitter. https://bit.ly/3H6F3Q7. Published November 30, 2022. Accessed December 1, 2022. FDA pulls U.S. authorization for Eli Lilly's Covid Drug Bebtelovimab. Reuters. https://bit.ly/3UiQyHa. Published November 30, 2022. Accessed December 1, 2022. Midyear clinical meeting 2022 - ASHP. MCM22. https://bit.ly/3B1dunI. Accessed December 1, 2022.

FDA Update on Digital Health Technologies in Clinical Trials Draft Guidance

PharmaTalkRadio

Play Episode Listen Later Nov 28, 2022 43:00

Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. Following the discussion, the FDA representatives hold open Q&A. Topics include: Guidance updatesThe requirements to test all of these digital health technologiesEfforts the agency is putting in place to harmonize the requirements across the boardGuidance to the industry in terms of how we create the harmonization. What do we need to disclose? And in what timeframe?FDA update on approval of additional clinical measures Speakers: Lauren Oliva, PharmD, Director, Global Regulatory Policy, Lead, Digital Health Regulatory Policy, BiogenAnindita Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDALeonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDAElizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA

FDA, CDC experts: What physicians need to know about tecovirimat (TPOXX) for treatment of monkeypox, Part 2

Moving Medicine

Play Episode Listen Later Nov 4, 2022 25:34

Experts from the FDA and CDC continue their discussion on tecovirimat, or TPOXX, for the treatment of monkeypox in infected individuals. In part two of this mini-series, experts answer physicians' questions about treatment for monkeypox. Guests include Adam Sherwat, MD, Deputy Director, Office of Infectious Disease at FDA's Center for Drug Evaluation and Research; Brett W. Petersen, MD, MPH, Deputy Chief, Poxvirus and Rabies Branch, CDC's Division of High-Consequence Pathogens and Pathology; and Timothy Wilkin, MD, MPH, Professor of Medicine and Assistant Dean for Clinical Research Compliance for Human Research Protections at Weill Cornell Medicine and TPOXX clinical trial lead.

children research professor office medicine md treatments cdc fda physicians mph deputy director infectious diseases pathologies deputy chief assistant dean weill cornell medicine drug evaluation poxvirus

Two new FDA approved drugs, AGA obesity treatment guidelines, and more!

Combinate Podcast - Med Device and Pharma

Play Episode Listen Later Oct 28, 2022 4:29

This week on Pharm5: Imjudo (tremelimumab) FDA approved Tecvayli (teclistamab-cqyv) FDA approved Cancer incidence up, mortality down Pharmacies administered >50% of COVID vaccines AGA Obesity Treatment Guidelines Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. AstraZeneca. https://bit.ly/3NevJKX. Published October 24, 2022. Accessed October 27, 2022. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab Plus durvalumab in unresectable hepatocellular carcinoma. NEJM Evidence. 2022;1(8). doi:10.1056/evidoa2100070 Center for Drug Evaluation and Research. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. U.S. Food and Drug Administration. https://bit.ly/3zqMixF. Accessed October 27, 2022. Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. October 2022. doi:10.1002/cncr.34479 Hunter E. Overall cancer death rates have declined, but rates among racial/ethnic minorities have not followed suit. Pharmacy Times. https://bit.ly/3gPg4G0. Published October 27, 2022. Accessed October 27, 2022. Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. Journal of the American Pharmacists Association. 2022. doi:10.1016/j.japh.2022.08.010 @JAPhAJournal. IN PRESS: Pharmacists delivered over 350 million clinical interventions during COVID pandemic. #TwitteRx #pharmacists #COVID19. Posted October 25, 2022. Accessed October 27, 2022. https://bit.ly/3U1xn4N. Grunvald E, Shah R, Hernaez R, et al. AGA clinical practice guideline on pharmacological interventions for adults with obesity. Gastroenterology. 2022;163(5):1198-1225. doi:10.1053/j.gastro.2022.08.045

FDA, CDC experts: What physicians need to know about tecovirimat (TPOXX) for treatment of monkeypox, Part 1

Moving Medicine

Play Episode Listen Later Oct 28, 2022 30:35

Experts from the AMA, FDA and CDC discuss tecovirimat, or TPOXX, for the treatment of monkeypox in infected individuals. The discussion provides background on tecovirimat, including its current status, availability and access while the drug is under an investigational new drug application. Guests include Adam Sherwat, MD, Deputy Director, Office of Infectious Disease at FDA's Center for Drug Evaluation and Research; Brett W. Petersen, MD, MPH, Deputy Chief, Poxvirus and Rabies Branch, CDC's Division of High-Consequence Pathogens and Pathology; and Timothy Wilkin, MD, MPH, Professor of Medicine and Assistant Dean for Clinical Research Compliance for Human Research Protections at Weill Cornell Medicine and TPOXX clinical trial lead.

049 - "What Does the Data Say?" with Shannon Hoste

Play Episode Listen Later Sep 7, 2022 46:05

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Human Factors vs. Usability Engineering vs. Design Validation - Risk Management and User Risk - Summative HF Evaluation and Sampling Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products. Formerly, Shannon worked as Team Lead for Human Factors in FDA's Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA).

president data fda pathway devices team lead human factors drug evaluation

Your Diabetes Risk: You're In Control | Midlife Women

The Flipping 50 Show

Play Episode Listen Later Jul 8, 2022 38:22

As a midlife woman your diabetes risk increases as hormones change. This episode intends to help you realize that you are in control. We include what may be reminders for many of you, or new points of awareness for others. This may be for you or for loved ones struggling with insulin resistance, pre-diabetes, or diabetes. In this episode I interview Dr. John Whyte, the Chief Medical Officer for WebMD, about his new book. Take Control of Your Diabetes Risk is available wherever books are sold and yet don't go get it yet, tune into this episode. You're going to love the simple tips reminding you of easy ways not to only avoid disease, but to feel better. Strength training to increase muscle which acts like a sponge for blood sugar. During Open Enrollment for the Flipping 50 Cafe you can gain access to made-for-menopause strength training programs and coaching from the leading hormone balancing fitness expert. Listen for the mic drop moment, followed by a comment we can each relate to all too well. We discuss some resources I'll add to the show notes as well. My Guest: Dr. John White is the Chief Medical Officer, WebMD. In this role, he leads efforts to develop and expand strategic partnerships that create meaningful change around important and timely public health issues. Prior to WebMD, he served as the director of professional affairs and stakeholder engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. 00:00 Questions we answer in this episode: 02:30 why do we have a diabetes epidemic in the US? 05:26 knowing genetics play a small percent, are genetics largely to blame or is it something else? 08:28 is it possible to either reverse diabetes entirely, or only to prevent it from occurring if you're at risk? are there issues specific to midlife women and diabetes? 20:42 how do hormones play a role? what's the role of stress in diabetes risk? what kinds of exercise choices do you find make the biggest difference? 31:12 are there types of exercise that don't help much at all specifically with diabetes and blood sugar? Connect with Dr John Whyte: https://www.webmd.com/takecontrol/diabetes On Social Media: Twitter: https://www.twitter.com/drjohnwhyte Linked In: https://www.linkedin.com/in/john-whyte-00092833/ The book you'll want for your library: https://www.amazon.com/Take-Control-Your-Diabetes-Risk/dp/0785240640/ref=sr_1_1?crid=497HJ4ETSJVQ&keywords=take+control+of+your+diabetes+risk&qid=1654539216&sprefix=take+control+%2Caps%2C80&sr=8-1 Resource mentioned in this episode: Continuous Glucose Monitor (for $25 off your first month, Rx not required): https://www.flippingfifty.com/glucose Other Episodes You May Like Related to Diabetes Risk: How a Continuous Glucose Monitor Could Help Weight Loss: https://www.flippingfifty.com/glucose-monitor/ My 30-Day Glucose Monitor Experiment: What Happened: https://www.flippingfifty.com/glucose-monitor/ 4 Ways Blood Sugar Could Halt Your Fat Burning and Weight Loss: https://www.flippingfifty.com/glucose-monitor/ Join the Free Diabetes Summit Now (July 2022)

36. Almut Winterstein, RPh, PhD, FISPE - How FDA evaluates safety of medications, Medical Marijuana

Unscripted

Play Episode Listen Later Jul 1, 2022 30:01

Almut Winterstein, RPh, PhD, FISPE, is the Professor and Chair of the Department of Pharmaceutical Outcomes and Policy, the Dr. Robert and Barbara Crisafi Chair for Medication Safety, and director of the Center for Drug Evaluation and Safety at the University of Florida College of Pharmacy.As an expert in drug safety she has chaired the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee. She also leads the Consortium for Medical Marijuana Clinical Outcomes Research created by Florida's state legislature. I learned so much in talking with her and think you will as well!

university phd professor food safety policy medications pharmacy drug administration medical marijuana consortium evaluates florida college rph drug safety medication safety drug evaluation pharmaceutical outcomes

Pronunciation Series Episode 6, IMLYGIC® (talimogene laherparepvec)

Pharmacist's Voice

Play Episode Listen Later Jul 1, 2022 8:57

Today, we're talking about IMLYGIC® (talimogene laherparepvec or T-VEC). In my pronunciation episodes, I say a brand drug name and its generic, break both drug names down into syllables, explain which syllable or syllable(s) have the emphasis, reveal the source(s) of my information, and put the written pronunciations of both in the show notes so that you see them and use them right away. The purpose of these pronunciation episodes is to provide the intended pronunciations of drug names from reliable sources. I want you to feel confident saying drug names and less frustrated learning them. Thank you for listening to episode 159 of The Pharmacist's Voice ® Podcast! To read the full show notes, visit https://www.thepharmacistsvoice.com. Click on the podcast tab, and search for episode 159. What is IMLYGIC® (talimogene laherparepvec)? It's a treatment for a skin cancer called melanoma. IMLYGIC® = imm LY jik (I prefer to write it imm LYE jik.) Verbal/audio pronunciation source: IMLYGIC® Healthcare Provider Video Written pronunciation source: IMLYGIC® medication guide on the FDA's website https://www.fda.gov/media/94135/download T-VEC = T-VEC Pronunciation sources: none talimogene laherparepvec = tal IM oh jeen la HER pa REP vek Verbal/audio pronunciation source: IMLYGIC® Healthcare Provider Video Written pronunciation source: USP Dictionary Online If you can't access the USP Dictionary Online for a written generic drug name pronunciation, and the drug name wasn't mentioned verbally in a video published by the drug sponsor, you can also call the drug sponsor's drug information department, and ask for help (during normal business hours). Another option is calling the Division of Drug Information at the FDA's Center for Drug Evaluation and Research during normal business hours. Calling either may sound intimidating, but if you're a voice actor, and you need to get it right, do the right thing. Use reliable sources; put drug names into your own words; and say them with confidence. You can do this! When you can see and hear a drug name pronunciation, it will be easier for you to say. If you like easy, get both! If YOU'RE interested in picking a drug name for a future pronunciation episode, please visit www.thepharmacistsvoice.com, and click the contact tab. Either leave me a voicemail message or type out a written message using the contact form. I'd love to hear from you! If you know someone who would like this episode or needs to hear it, please share it with them. Thank you for listening to The Pharmacist's Voice ® Podcast Episode 159! Thank you USP Legal Department for permission to use written pronunciations from the USP Dictionary Online in my YouTube videos and podcast show notes. Mentioned in this episode The Pharmacist's Voice Podcast Episode 155/Pronunciation Episode 5 The Pharmacist's Voice Podcast Episode Pronunciation 148/Episode 4 The Pharmacist's Voice Podcast Episode 142/Pronunciation Episode 3 The Pharmacist's Voice Podcast Episode 138/Pronunciation Episode 2 The Pharmacist's Voice Podcast Episode 134/Pronunciation Episode 1 IMLYGIC® website (accessed 6-26-22) https://www.imlygic.com IMLYGIC® Healthcare Provider Video (you can hear the pronunciation of IMLYGIC) IMLYGIC® medication guide on the FDA's website https://www.fda.gov/media/94135/download (you can see the pronunciation of IMLYGIC) Medication Guide tab on IMLYGIC's website USP Dictionary Online (USAN) sales page (you can see the written pronunciation of talimogene laherparepvec. Division of Drug Information at the FDA/CDER (look at the “Contact Us” section)

business school research podcasting fda pharmacists verbal pronunciation ly dave jackson voice podcast lye drug evaluation drug information

The Future Of Healthcare with Dr. John Whyte, CMO WebMD | Healthcare Trailblazers Ep. 8

Healthcare Trailblazers

Play Episode Listen Later Jun 28, 2022 36:47

About John WhyteJohn Whyte, MD, MPH, is a well-known physician and writer who has spent nearly two decades informing the public about health issues. WebMD's Chief Medical Officer is Dr. Whyte. Whyte leads efforts to build and deepen strategic relationships that result in significant change around critical and relevant public health challenges in this capacity. Prior to joining WebMD, Whyte worked at the US Food and Drug Administration's Center for Drug Evaluation and Research as the director of professional relations and stakeholder engagement. Whyte worked with health care professionals, patients, and patient advocates to provide a focal point for advocacy, improved two-way communication, and collaboration, as well as to assist them in navigating the FDA on matters relating to medication development, review, and safetyLearn more about Previva Health Group:Website: https://previva.com/ LinkedIn: https://www.linkedin.com/company/previva-health-group/Learn more about John Whyte:LinkedIn: https://www.linkedin.com/in/john-whyte-00092833

research healthcare md fda mph chief medical officers trailblazers drug administration webmd whyte us food drug evaluation john whyte

Monkeypox vaccine, Ukoniq loses FDA approval, and more!

Play Episode Listen Later Jun 3, 2022 4:02

This week on Pharm5: Monkeypox vaccine for work-related exposure to orthopoxvirus Lymphoma drug Ukoniq (umbralisib) loses FDA approval Psychedelic, synthetic psylocibin tested for use in severe depression Expanding uses for antineoplastic agent azacitidine Addendum to the 2022 Standards of Medical Care in Diabetes References: Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. Centers for Disease Control and Prevention. https://bit.ly/3MkpYtq. Published May 27, 2022. Accessed June 2, 2022. FDA withdraws lymphoma drug approval after investigation. Medscape. https://wb.md/3GJIMRw. Published June 1, 2022. Accessed June 2, 2022. Melville NA. Psilocybin effective up to 12 weeks in severe depression. Medscape. https://wb.md/3xeigg5. Published June 2, 2022. Accessed June 2, 2022. DRUGS@FDA: FDA-approved drugs. accessdata.fda.gov. https://bit.ly/3Mr6kvT. Accessed June 2, 2022. Center for Drug Evaluation and Research. FDA approves azacitidine. U.S. Food and Drug Administration. https://bit.ly/3xdSoRw. Published May 20, 2022. Accessed June 2, 2022. FDA approves Ivosidenib/Azacitidine for certain patients with newly diagnosed AML. The ASCO Post. https://bit.ly/3GHaoGY. Published May 26, 2022. Accessed June 2, 2022. Addendum. 10. cardiovascular disease and risk management: Standards of medical care in diabetes–2022. diabetes care 2022;45(suppl. 1):S144–S174. Diabetes Care. May 2022. doi:10.2337/dc22-ad08 Aspirin use to prevent cardiovascular disease: Preventive medication. Recommendation: Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication | United States Preventive Services Taskforce. https://bit.ly/3m93gtn. Published April 26, 2022. Accessed Jun 2, 2022.

Paxlovid side effects, treatment timelines and more with John Farley, MD, MPH

covid-19 research office md treatments fda timeline mph side effects infectious diseases timelines new drugs paxlovid md mph drug evaluation john farley todd unger

Play Episode Listen Later May 23, 2022 13:45

AMA CXO Todd Unger discusses what physicians and patients need to know about Paxlovid with John Farley, MD, MPH, director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research's Office of New Drugs at the FDA. For more information on Paxlovid from the FDA, visit: https://www.fda.gov/drugs/news-events-human-drugs/fda-updates-paxlovid-health-care-providers

April 15, 2022

This Week in Health Innovation

Play Episode Listen Later Apr 15, 2022 4:03

This week on Pharm5: FDA and DEA warn of online CII sales Ultomiris (ravulizumab) improves ADLs and QOL for up to 60 weeks in patients with myasthenia gravis Fidaxomicin's biomolecular specificity to C. diffunveiled Sotrovimab has lost its EUA for treatment of COVID-19 Results from Phase II of ASHP's Residency Match Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD References: McCarthy L-J. FDA and DEA warn online pharmacies illegally selling Adderall to consumers. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-and-dea-warn-online-pharmacies-illegally-selling-adderall-consumers. Published April 12, 2022. Accessed April 12, 2022. Ultomiris® (ravulizumab-CWVZ) demonstrated sustained improvements in functional activities and quality of life in adults with generalized myasthenia gravis through 60 weeks. AstraZeneca US. https://www.astrazeneca-us.com/media/press-releases/2022/ultomiris-demonstrated-sustained-improvements-in-functional-activities-and-quality-of-life-in-adults-with-generalized-myasthenia-gravis-through-60-weeks.html. Published April 6, 2022. Accessed April 14, 2022. Ultomiris (ravulizumab-CWVZ). Package insert. Alexion Pharmaceuticals, Inc; 2018. Cao X, Boyaci H, Chen J, Bao Y, Landick R, Campbell EA. Basis of narrow-spectrum activity of fidaxomicin on Clostridioides difficile. Nature. April 2022. doi:10.1038/s41586-022-04545-z Rockefeller University. How a narrow-spectrum antibiotic takes aim at C. Diff. EurekAlert! https://www.eurekalert.org/news-releases/948950. Published April 6, 2022. Accessed April 14, 2022. Center for Drug Evaluation and Research. FDA updates Sotrovimab Emergency Use Authorization. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization. Published April 5, 2022. Accessed April 14, 2022. Person, Kavya B AM. Worldwide covid cases surpass 500 mln as Omicron variant BA.2 surges. Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/worldwide-covid-cases-surpass-500-mln-omicron-variant-ba2-surges-2022-04-14/. Published April 14, 2022. Accessed April 14, 2022. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published April 13, 2022. Accessed April 14, 2022. ASHP Match Statistics. ASHP Match | Statistics of the Match. https://natmatch.com/ashprmp/stats.html. Published April 13, 2022. Accessed April 14, 2022.

Meet @WebMD Chief Medical Officer & Author Dr. John Whyte @drjohnwhyte

Play Episode Listen Later Apr 6, 2022 26:00

Global health thought leader and host Gil Bashe (@Gil_Bashe) and #publichealth advocate, producer & co-host Gregg Masters (@GreggMastersMPH) engage the Chief Medical Officer of @WebMD, and recent author of "Take Control of Your Cancer Risk" Dr. John Whyte @drjohnwhyte. We discuss the current state of the innovation economy, it's principal headwinds, tailwinds and opportunities. In his role as chief medical officer of WebMD, Whyte leads efforts to develop and expand strategic partnerships that create meaningful change around important and timely public health issues. Prior to WebMD, Whyte served as the director of professional affairs and stakeholder engagement at the Center for Drug Evaluation and Research at the US Food and Drug Administration. ==##==

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A conversation with Dr. John Whyte, Chief Medical Officer of WebMD and author of the new book, Take Control of Your Diabetes Risk

Daily Remedy

Play Episode Listen Later Mar 25, 2022 26:32

We discuss Dr. John Whyte's latest book, Take Control of Your Diabetes Risk, and reveal what it offers patients struggling with diabetes. Dr. Whyte is the Chief Medical Officer, WebMD. He leads efforts to develop and expand strategic partnerships that create meaningful change around important and timely public health issues. Prior to WebMD, Whyte served as the director of professional affairs and stakeholder engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.

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Drug Development and Approval: A Conversation with the FDA

Real Talk: Eosinophilic Diseases

Play Episode Listen Later Feb 23, 2022 31:15

For many subsets of eosinophilic associated disease, there is not yet an FDA-approved therapy available. There are several therapies in various stages of development for eosinophilic esophagitis, but what exactly are the steps that need to be taken to bring a therapy to market and what is the role of the U.S. Food and Drug Administration (FDA) in medications coming to market? In this episode, host Ryan Piansky, guest host Mary Jo Strobel, and Dr. Scott Winiecki discuss this topic. Dr. Scott Winiecki is the Director of the Safe Use Initiative at the FDA. He completed his M.D. at the University of Maryland and his pediatric training at the Children's Hospital of Philadelphia. After 12 years in private pediatric practice, he joined the U.S. Food and Drug Administration in 2011. After working on immune globulin products and vaccines for five years, he joined the Center for Drug Evaluation and Research (CDER) in September 2016. In his current role at the FDA, he is working to reduce preventable harm from medications by collaborating with both public and private groups within the healthcare community. In this episode, Dr. Winiecki explains the role of the FDA in getting a drug to market. He talks about the different stages a drug has to go through before it reaches the FDA and the phases of clinical trials in assessing a drug's suitability for public use. Dr. Winiecki gives us an inside look at the intricacies of ensuring the safety and efficacy of a drug, as well as how patients can work with the FDA in terms of drug development. Tune in to find out more. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own. Key Takeaways: [1:51] Education partner: Bristol Myers Squibb [1:54] Mary Jo introduces the guest for this episode, Dr. Scott Winiecki. [3:14] Dr. Winiecki shares a bit about his background and his role at the FDA. [3:58] What are some of the steps a drug typically goes through before it reaches the FDA for approval? [5:04] What are the phases of a clinical trial and what is being assessed in each phase? [8:01] How does the process differ if the drug is for rare diseases, or if the drug is already approved for some other use case, or approved in other countries? [9:15] How does the FDA engage with patients that are enrolled in a clinical trial? [9:45] What protections are in place for people participating in a clinical trial? [10:46] One concern patients may have in deciding whether to participate in a clinical trial involving investigational drugs is whether they will be able to access that medicine after the trial ends. Dr. Winiecki explains how decisions are made regarding post-trial access to a drug. [11:50] The FDA has a variety of different designations it gives to drugs. What does each of these designations mean? [16:55] What are some circumstances that might cause a delay in the approval process? [17:56] On average, how long is the development timeline for a drug to come to market? [18:25] Who decides which disorder a drug will be approved for? [20:20] How does it determine if a medicine would be made available over the counter or by prescription? [20:58] What is the FDA involvement after a drug is approved? [22:27] How would patients report side effects that they believe might be caused by a drug? [23:19] What are some considerations in the labeling of allergens used as inactive ingredients in drugs? [24:10] What is the role that patients play in drug development? What is the value of having the patient and families engaged and involved? [26:41] What are some ways patients and families can engage with the FDA, apart from the PFDD meetings? [27:40] What are some FDA programs that might focus on rare disease? [29:23] For more information and resources, visit the FDA website. Mentioned in This Episode: American Partnership for Eosinophilic Disorders (APFED) APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Dr. Scott Winiecki FDA FDA Expedited Review Programs MedWatch Program Call FDA — 1-888-INFO-FDA (1-888-463-6332) Clinical trials for eosinophil-associated diseases ClinicalTrials.gov EOS Connections Online Community This episode is brought to you thanks to the support of our Education Partner Bristol Myers Squibb. Tweetables: “Pre-clinical research can answer basic questions about drug safety, but they're not a substitute for ways the drug can interact in the human body.” — Dr. Winiecki “The FDA continues to look at benefits and risks of a therapy throughout its lifecycle even after a drug is approved.” — Dr. Winiecki “It's also noteworthy that most rare diseases do not have any FDA approved treatments.” — Dr. Winiecki “The FDA has a really important role in protecting patients enrolled in clinical trials.” — Dr. Winiecki “The FDA estimates it takes about 8.5 years to study and test a new drug before it can be approved for the general public.” — Dr. Winiecki “Patient involvement is very important and perhaps even more important in the context of rare diseases because obviously, no one knows the disease as well as the patient and what sort of outcomes or benefits would be important.” — Dr. Winiecki

The FDA on Molnupiravir and COVID-19: What physicians need to know, Part III

covid-19 research office md fda physicians infectious diseases therapeutics new drugs molnupiravir antivirals drug evaluation

Play Episode Listen Later Feb 18, 2022 12:33

In part three of this three-part series, Aimee Hodowanec, MD, senior medical officer, Division of Antivirals, Office of Infectious Disease in the Center for Drug Evaluation and Research's Office of New Drugs, FDA, discusses what physicians need to know about Molnupiravir as treatment for COVID-19.

The FDA on Paxlovid and COVID-19: What physicians need to know, Part II

covid-19 research office md fda physicians infectious diseases harmon therapeutics new drugs paxlovid monoclonal antivirals senior medical officer drug evaluation

Play Episode Listen Later Feb 15, 2022 14:49

In part two of this three-part series, Stephanie Troy, MD, senior medical officer, Division of Antivirals, Office of Infectious Disease in the Center for Drug Evaluation and Research's Office of New Drugs, FDA, discusses what to know about Paxlovid as treatment for COVID-19.

February 11, 2022

Play Episode Listen Later Feb 11, 2022 3:44

This week on Pharm5: CVS and Walgreens lift limits on at-home COVID-19 tests Enjaymo (sutimlimab) approved for use in adults with cold agglutinin disease The FDA's draft guidance for development of non-opioid analgesics is open for public comments until April 11th, 2022 SURPASS-5 shows promising results for A1c lowering and weight loss at 40-weeks with tirzepatide Mark Cuban's CostPlus Drug Company has launched with limited formulary References: Oshin O. CVs, Walgreens remove limits on at-home covid-19 tests. TheHill. https://thehill.com/policy/healthcare/public-global-health/593033-cvs-walgreens-remove-limits-on-at-home-covid-19-tests. Published February 6, 2022. Accessed February 10, 2022. Enjaymo [package insert]. U.S. Food and Drug Administration Website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf?utm_medium=email&utm_source=govdelivery. Revised February 2022. Cold agglutinin disease. NORD (National Organization for Rare Disorders). https://rarediseases.org/rare-diseases/cold-agglutinin-disease/#:~:text=Cold%20agglutinin%20disease%20(CAD)%20is,subtype%20of%20autoimmune%20hemolytic%20anemia. Published November 17, 2020. Accessed February 10, 2022. Commissioner of the FDA takes steps aimed at fostering development of non-addictive alternatives to opioids for acute pain management. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-aimed-fostering-development-non-addictive-alternatives-opioids-acute-pain-management?utm_campaign=&utm_content=1644424858&utm_medium=FDA%2CU.S.%2BFood%2Band%2BDrug%2BAdministration&utm_source=facebook%2Clinkedin. Accessed February 10, 2022. Center for Drug Evaluation and Research. Development of non-opioid analgesics for acute pain; draft guidance fo. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-acute-pain-draft-guidance-industry. Accessed February 10, 2022. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous Tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes. JAMA. 2022;327(6):534. doi:10.1001/jama.2022.0078 Costplusdrugs.com. https://costplusdrugs.com/. Accessed February 10, 2022. Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD

The FDA on Monoclonal Antibody Therapeutics: What physicians need to know, Part I

HealthcareNOW Radio - Insights and Discussion on Healthcare, Healthcare Information Technology and More

Play Episode Listen Later Feb 11, 2022 10:04

AMA president Gerald Harmon, MD, welcomes experts from the U.S. Food and Drug Administration (FDA) to discuss what prescribers need to know about COVID-19 therapeutic drugs, Paxlovid and Molnupiravir. Alternative treatment options for high-risk outpatients with mild-moderate COVID-19 are also discussed. Guest: John Farley, MD, MPH, director, Office of Infectious Diseases in the Center for Drug Evaluation and Research's Office of New Drugs, FDA

Épisode 84 – Spécial COVID #10 – Vaccins pédiatriques et traitements antiviraux

Pharmascope

Play Episode Listen Later Dec 12, 2021 33:41

Un nouvel épisode du Pharmascope est disponible et on retourne une fois de plus à un classique pandémique: la COVID-19. Dans ce 84ème épisode, Nicolas et Sébastien discutent des vaccins chez les 5 à 11 ans ainsi que des nouveaux traitements antiviraux oraux. Les objectifs pour cet épisode sont les suivants: Discuter de l'efficacité de la vaccination contre la COVID-19 chez les enfants entre 5 et 11 ansConseiller un parent sur les risques et les bénéfices de la vaccination chez les enfants entre 5 et 11 ansExpliquer les risques et les bénéfices des traitements antiviraux oraux dans le traitement de la COVID-19 Ressources pertinentes en lien avec l'épisode Vaccins pédiatriquesWalter EB et coll. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021. doi:10.1056/NEJMoa2116298 (online ahead of print). Mevorach D et coll. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 202. doi:10.1056/NEJMoa2109730 (online ahead of print). Ministère de la Santé et des Services sociaux. Vaccins COVID-19 ARNm : vaccins à ARN messager contre la COVID-19. Protocole d'immunisation du Quévec. Novembre 2021. Traitements antiviraux oraux Évaluation du molnupiravir à la FDAU.S. Food and Drug Administration Center for Drug Evaluation and Research FDA Briefing Document Antimicrobial Drugs Advisory Committee Meeting November 30, 2021. Communiqué de presse de MerckMerck and Ridgeback's Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study. Octobre 2021. Communiqué de presse de PfizerPfizer's novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 EPIC-HR study. Novembre 2021.

Health UnaBASHEd: Meet John Whyte MD MPH CMO @WebMD

Play Episode Listen Later Nov 28, 2021 25:08

S1E2: Global health thought leader and host Gil Bashe and public health advocate, producer & co-host Gregg Masters engage the Chief Medical Officer of WebMD, and recent author of "Take Control of Your Cancer Risk" Dr. John Whyte. The three discuss the current state of the innovation economy, its principal headwinds, tailwinds, and opportunities. In his role as chief medical officer of WebMD, Whyte leads efforts to develop and expand strategic partnerships that create meaningful change around important and timely public health issues. Prior to WebMD, Whyte served as the director of professional affairs and stakeholder engagement at the Center for Drug Evaluation and Research at the US Food and Drug Administration. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

health research take control chief medical officers drug administration webmd whyte md mph us food unabashed drug evaluation john whyte gil bashe gregg masters

Interview with Renu Lal, PharmD - Lieutenant Commander, U.S. Public Health Service Commissioned Corps

Pharmacist's Voice

Play Episode Listen Later Nov 19, 2021 37:27

Renu Lal, PharmD, is a Team Lead in the Division of Drug Information (DDI) within the Food and Drug Administration/Center for Drug Evaluation and Research/Office of Communications. Along with directly communicating with the public, the Division is responsible for many initiatives and outreach programs such as the CDER Small Business and Industry Assistance (SBIA) Program; FDA Drug Info Rounds video; Drug Safety podcasts; Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.), Webinars for healthcare professionals and students, and more. Renu is an officer in the Commissioned Corps of the U.S. Public Health Service (U.S. PHS), a uniformed service committed to protecting, promoting, and advancing the health and safety of the nation. Mentioned in this episode United States Public Health Service (U.S. PHS) JRCOSTEP and SRCOSTEP Programs for students Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) FDA Drug Safety Podcasts Small Business and Industry Assistance (SBIA) Chronicles Podcast FDA Drug Info Rounds Video Series Webinars for healthcare professionals and students UCONN School of Pharmacy Medical University of South Carolina College of Pharmacy The University of Toledo College of Pharmacy U.S. Department of Health and Human Services Indian Health Service BOP (Federal Bureau of Prisons) NIH (National Institutes of Health) CDC (Centers for Disease Control and Prevention) FDA (Food and Drug Administration) EPA (Environmental Protection Agency) SAMSHA (Substance Abuse and Mental Health Services Administration) CDERLearn (CDER Learn Training and Education) Subscribe to or Follow The Pharmacist's Voice Podcast! Apple Podcasts Google Podcasts Spotify Amazon/Audible Read the full show notes at The Pharmacist's Voice ® Podcast https://www.thepharmacistsvoice.com/podcast Dr. Renu Lal's path from pharmacy school to the U.S. Public Health Service was not a direct one. She earned her BS Degree in Pharmacy from UCONN in 1998. Then, she earned her Post-Bac PharmD from the Medical University of South Carolina in Charleston in 2000. Renu did not know what she wanted to do with her PharmD when she graduated. According to Renu, “It's ok to not know and make it up as you go along.” She spent time in community practice as a floater, then entered the U.S. PHS. Her PHS service was interrupted briefly when she left PHS to join a clinical regulatory team at Genentech in San Francisco, CA. When that role ended, she rejoined PHS. As of October 2021, her total service time is approximately 10 years. While in her undergrad program at UCONN, Renu learned about PHS. A speaker from the Indian Health Service spoke to her class. After finishing her BS Degree in Pharmacy, Renu joined the U.S. PHS as a JRCOSTEP and completed a paid, 4-month rotation at a Psych Hospital in SE DC called St. Elizabeth's Hospital. She loved the experience and thought it was amazing! Students can join either the JRCOSTEP Program or the SRCOSTEP Program. Both are paid positions with benefits. Visit https://www.usphs.gov/students/ to learn more. During our conversation, I talked about my experience with PHS at the Federal Bureau of Prisons. I did an 8-week rotation at FCI Milan during the last semester of my BS Pharm Degree program at The University of Toledo College of Pharmacy in 2001. My pharmacist in charge was creative and resourceful, and she did amazing things with a small formulary. I learned a lot from her and that experience. I wanted to join the Navy upon graduation, but I was medically disqualified due to asthma. The United States Public Health Service (U.S. PHS) is led by the Surgeon General of the U.S. and is more than 200 years old. It is one of eight uniformed services and is the only one dedicated solely to protecting and advancing America's Public Health. As a U.S. PHS Officer, Renu is first in line to defend America from public health threats, including deploying for public health emergencies. She has deployed many times and provided essential healthcare to underserved and vulnerable populations. The U.S. Public Health Service used to be “pharmacy's best kept secret,” but that's not true anymore because PHS has played a prominent role in response to COVID. As a PHS Officer, there is an opportunity to serve in many HHS (U.S. Department of Health and Human Services) agencies. Examples include IHS (Indian Health Service), BOP (Federal Bureau of Prisons), NIH (National Institutes of Health), CDC (Centers for Disease Control and Prevention), FDA (Food and Drug Administration), EPA (Environmental Protection Agency), SAMSHA (Substance Abuse and Mental Health Services Administration), and others. Being an Officer makes it easy to transfer among agencies. According to Renu, PHS Officer benefits are great! They are on the military pay scale with paid vacation, retirement benefits (with minimum of 20 years of service), medical benefits, the GI Bill and more. To learn more about age restrictions and eligibility requirements to serve, visit https://www.usphs.gov. Resources that DDI (Department of Drug Information) offers SBIA Program Free Conferences and Webinars Podcasts FDA Drug Safety Podcasts Drug Information Soundcast in Clinical Oncology “D.I.S.C.O.” SBIA Chronicles (trending regulatory topics) Drug Info Rounds educational videos featuring DDI pharmacists CDER Learn - portal for all CE activities. Webinars and podcasts are there. We concluded the interview with Renu's advice for currently-practicing or newly graduated pharmacists: Do and learn what interests you, and the rest will fall into place. Thank you for listening to The Pharmacist's Voice ® Podcast Episode 123!

The FDA's Dr. John Farley talks about why ivermectin should not be used to prevent or treat COVID

covid-19 research office md treat fda prevent mph infectious diseases ivermectin new drugs drug evaluation john farley

Play Episode Listen Later Sep 9, 2021 10:10

A discussion with John Farley, MD, MPH, director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research's Office of New Drugs at the FDA, about what physicians and patients really need to know about ivermectin.

About the NIH, Industry, and the R&D Ecosystem, with Richard Moscicki, PhRMA

Vital Health Podcast

Play Episode Listen Later Jul 8, 2021 27:20

Richard Moscicki is the Executive Vice President for Science and Regulatory Advocacy and the Chief Medical Officer at Pharmaceutical Research and Manufacturers of America (PhRMA). Previously he was the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and the Chief Medical Officer at Genzyme Corporation. In this podcast, we discuss the U.S. R&D ecosystem and the vital roles that NIH and the private sector play in bringing new therapies to patients. Richard was previously at Massachusetts General Hospital (MGH) and Harvard Medical School, and this strong academic background combined with his industry knowledge gives him a unique perspective on both sides of public and industrial R&D, as well as how NIH developed intellectual property moves from the ‘Eureka' phase to becoming an actual medicine. Our conversation includes President Biden's new $6.5 billion proposal called ARPA-H, modeled on DARPA, specifically for drug discovery, and where those efforts would be best directed to facilitate needed medicines to address unmet medical needs. We also touch on how the rapid evaluation and approval of vaccines for COVID-19 could serve as an improved regulatory blueprint for accelerated evidence driven access to patients.

covid-19 science food joe biden ecosystem harvard medical school chief medical officers nih eureka manufacturers drug administration darpa massachusetts general hospital mgh pharmaceutical research phrma arpa h drug evaluation fda center

Quality Management Maturity – A Pilot Program of the FDA

Voices In Validation

Play Episode Listen Later Jun 22, 2021 34:17

This week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them. Resources from this episode: Pharmaceutical Quality for the 21st-century report Quality Management Maturity Pilot Program as announced by the FDA About Our Guests: CDR Lyle Canida CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives. Jennifer Maguire, Ph.D. Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University. Nandini Rakala, Ph.D. Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master's degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor's degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies. Alex Viehmann Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance. The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment. Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control. He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions. Since joining OQS in 2015, Alex has guided the development of OPQ's Quality Metrics program, CDER/ORA's New Inspection Protocol Project (NIPP), and OQS's analytics and modeling program. He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP). He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor's degree in economics from the University of Maryland at College Park. Carla Lundi Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER's Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

What's the deal with that new Alzheimer's drug?

The Weeds

Play Episode Listen Later Jun 16, 2021 65:59

Matt and Dara are joined by Vox's Dylan Scott to learn about aducanumab, the new drug that was recently approved by the FDA for treating Alzheimer's disease despite a lack of evidence of its effectiveness, possibly serious side effects, and a jaw-droppingly high price tag. Matt, Dara, and Dylan discuss the situation in light of lessons learned, or not quite learned, from the global pandemic. Then, some research is discussed that evaluates the effects of work requirements on supplemental nutrition assistance program (SNAP) participation and the workforce. Resources: "The new Alzheimer's drug that could break Medicare" by Dylan Scott (June 10; Vox) "FDA's Decision to Approve New Treatment for Alzheimer's Disease" by Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research (June 7) "The maddening saga of how an Alzheimer's 'cabal' thwarted progress toward a cure for decades" by Sharon Begley (June 25, 2019; STAT News) "What the Rich Don't Want to Admit About the Poor" by Ezra Klein (June 13; New York Times) White paper: "Employed in a SNAP? The Impact of Work Requirements on Program Participation and Labor Supply" by Colin Grey, et al. (Sept. 2019) Hosts: Matt Yglesias (@mattyglesias), Slowboring.com Dara Lind (@DLind), Immigration Reporter, ProPublica Dylan Scott (@dylanlscott), Policy Reporter, Vox Credits: Erikk Geannikis, Editor and Producer As the Biden administration gears up, we'll help you understand this unprecedented burst of policymaking. Sign up for The Weeds newsletter each Friday: vox.com/weeds-newsletter. The Weeds is a Vox Media Podcast Network production. Want to support The Weeds? Please consider making a contribution to Vox: bit.ly/givepodcasts About Vox Vox is a news network that helps you cut through the noise and understand what's really driving the events in the headlines. Follow Us: Vox.com Facebook group: The Weeds Learn more about your ad choices. Visit podcastchoices.com/adchoices

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The 2 View: Episode 6

2 View: Emergency Medicine PAs & NPs

Play Episode Listen Later Jun 14, 2021 87:25

Welcome to Episode 6 of “The 2 View,” the podcast for EM and urgent care nurse practitioners and physician assistants! Show Notes for Episode 6 of “The 2 View” Lyme Disease Arumugam S, Nayak S, Williams T, et al. A Multiplexed Serologic Test for Diagnosis of Lyme Disease for Point-of-Care Use. J Clin Microbiol. Published November 22, 2019. Accessed June 1, 2021. https://journals.asm.org/doi/full/10.1128/JCM.01142-19 Gastroparesis Camilleri, M. MD. Gastroparesis: Etiology, Clinical Manifestations, and Diagnosis. Uptodate.com. Updated September 30, 2020. Accessed June 1, 2021. https://www.uptodate.com/contents/gastroparesis-etiology-clinical-manifestations-and-diagnosis?search=gastroparesis§ionRank=1&usagetype=default&anchor=H859989&source=machineLearning&selectedTitle=2~150&displayrank=2 Center for Drug Evaluation, Research. How to Request Domperidone for Expanded Access Use. Fda.gov. Published February 2, 2021. Accessed June 1, 2021. https://www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use Gastroparesis. American College of Gastroenterology. Updated December 2012. Accessed June 1, 2021. https://gi.org/topics/gastroparesis/ Gastroparesis - NORD (national organization for rare disorders). Rarediseases.org. Published February 11, 2015. Accessed June 1, 2021. https://rarediseases.org/rare-diseases/gastroparesis/ Spiked Helmet EKG Sign: See full show notes here: https://bit.ly/3xaCoga Career Advancements: Side Gigs & Moving Up in the Workforce Passive Income. The List of Physician Side Hustles. Passiveincomemd.com. Published February 4, 2020. Accessed June 1, 2021. https://passiveincomemd.com/list-physician-side-hustles/ Shemmassian. 14 Physician Side Gigs to Accelerate Your Income — Shemmassian Academic Consulting. Shemmassianconsulting.com. Published March 26, 2020. Accessed June 1, 2021. https://www.shemmassianconsulting.com/blog/physician-side-gigs Sitar, D. 11 Side Gigs You Can Do Entirely from Home. Thepennyhoarder.com. Published July 7, 2020. Accessed June 1, 2021. https://www.thepennyhoarder.com/make-money/side-gigs/work-from-home-coronavirus/ Recurring Sources Center for Medical Education. Ccme.org. http://ccme.org The Proceduralist. Theproceduralist.org. http://www.theproceduralist.org The Procedural Pause. Emergency Medicine News. Lww.com. https://journals.lww.com/em-news/blog/theproceduralpause/pages/default.aspx The Skeptics Guide to Emergency Medicine. Thesgem.com. http://www.thesgem.com Trivia Question: Send answers to 2viewcast@gmail.com Last month we asked you a trivia question regarding needlestick safety and prevention – who was the President of the United States that signed the Needlestick Safety and Prevention Act into law and who was the Massachusetts nurse whose advocacy for sharps injury safety helped the act pass and who later became president of the American Nurses Association? The correct answer was President Bill Clinton and Karen Daley, PhD, MPH, RN, FAAN. Please note that for this month, if you get the trivia question correct, you will win your course registration to one of our LIVE EM Boot Camp Courses, available in July and November of this year! It's a great course so be sure to download and listen to the episode for the question! Please email us your guesses at 2viewcast@gmail.com and tell us who you want to give a shout-out to.

Pink Sheet Podcast: COVID-19 Vaccine Blood Clots, Virtual Inspection Guidance, New CDER Director

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Play Episode Listen Later Apr 16, 2021 31:01

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

Police experts at detecting marijuana poised for starring role in New York

The Capitol Pressroom

Play Episode Listen Later Mar 26, 2021 13:59

Mar. 26, 2021 - One of the hurdles holding up marijuana legalization in the Empire State is the ability to detect impaired driving. We talked with Kyle Clark, Project Manager of the Drug Evaluation and Classification Program at the International Association of Chiefs of Police, about the technology and practices evaluators use.

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Track and Trace: Pharmacists New Responsibilities to Combat Counterfeit Drugs | Locked on Pharmacy

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Play Episode Listen Later Jan 7, 2021 12:21

In 2013, Congress passed the Drug Supply Chain Security Act, often called the “track and trace” law, which is designed protect consumers against counterfeit drugs. In November 2020, new requirements for pharmacists took effect. To learn more about what pharmacists need to know, we spoke with Ilisa Bernstein, senior vice president for government affairs and pharmacy practice at APhA; and Leigh Verbois, director of the Office of Drug Security, Integrity and Response for the FDA's Center for Drug Evaluation and Research. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Track and Trace: Pharmacists New Responsibilities to Combat Counterfeit Drugs | Locked on Pharmacy

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Play Episode Listen Later Jan 7, 2021 11:06

In 2013, Congress passed the Drug Supply Chain Security Act, often called the “track and trace” law, which is designed protect consumers against counterfeit drugs. In November 2020, new requirements for pharmacists took effect. To learn more about what pharmacists need to know, we spoke with Ilisa Bernstein, senior vice president for government affairs and pharmacy practice at APhA; and Leigh Verbois, director of the Office of Drug Security, Integrity and Response for the FDA’s Center for Drug Evaluation and Research. See omnystudio.com/listener for privacy information.

Track and Trace: Pharmacists New Responsibilities to Combat Counterfeit Drugs | Locked on Pharmacy

Locked On Pharmacy

Play Episode Listen Later Jan 7, 2021 11:06

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Compounded Drugs

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Play Episode Listen Later Jan 5, 2021 10:57

Gail Bormel from the Office of Compliance in FDA’s Center for Drug Evaluation and Research joins Dr. Shah for a discussion on drug compounding and its contribution to fighting COVID-19.

A Shot at Hope – What We Know About the Covid-19 Vaccine | Episode 5

The Healthy Edit

Play Episode Listen Later Dec 21, 2020 66:04

This episode of Healthy Chats originally aired on December 18 as a virtual Town Hall with a full focus on the Covid-19 vaccine. The Town Hall was made available to anyone interested in attending via HealthCorps' social media channels. The conversation between HealthCorps CEO Amy Braun and the panel of experts was determined by questions submitted by those attending the virtual Town Hall. Based on those questions, experts discussed the FDA's approval process and the distribution process; how states plan on providing the vaccine (such as who receives it after healthcare workers); the vaccine's efficacy and the challenges public health officials face to ensure the vaccine is equitably distributed, specifically historic and cultural mistrust within the Black and Brown communities. Joining Amy for the conversation are:Mr. Victor Vandell, a participant in Pfizer's Covid 19 vaccine trials.Dr. John Whyte, Chief Medical Officer of WebMD. Formerly he was the Director of Professional Affairs and Stakeholder Engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.Dr. Josh Sharfstein Vice Dean for Public Health Practice & Community Engagement at Johns Hopkins Bloomberg School of Public Health Previously, he served as Secretary of the Maryland Department of Health and Mental Hygiene, as Principal Deputy Commissioner of the U.S. Food and Drug Administration, and as Commissioner of Health for Baltimore City.Dr. Mena Mirhom Board Certified Psychiatrist at Columbia University is a Board Certified Psychiatrist who specializes in the treatment of Adults and Adolescents. He completed his adult psychiatry training in the Mount Sinai health system in New York City and his fellowship training at Columbia University Medical Center. Dr. Marjorie Bessel is the chief clinical officer at Banner Health in Arizona. Dr. Bessel earned a B.S. in biology, magna cum laude, from Syracuse University and she attended Rush Medical College in Chicago, Illinois, where she was presented with the James B. Herrick award for most outstanding performance in internal medicine.HealthCorps' founder and Chairman, Dr. Oz also joined us towards the end of our conversation to share his insights.Support the show (https://www.healthcorps.org/donate)

Advanced Manufacturing

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Play Episode Listen Later Dec 15, 2020 11:18

Dr. Jeffrey C. Baker, Deputy Director of the FDA’s Office of Biotechnology Products in the Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on how FDA’s efforts help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety.

Blowing the Whistle on the FDA

Health Sovereign Podcast

Play Episode Listen Later Dec 15, 2020 11:03

Renee Dufault finds traces of mercury in corn syrup. The FDA tells her not to investigate. Rosemary Johann-Liang wants to place a strong warning label on the drug Avandia. Her superiors transfer away her responsibilities on that drug. David Graham says of the deadly Vioxx, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless...Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.” And that’s just the start. This episode also features the FDA spying, a criminal investigation of the head of the FDA, and even more whistleblowers. What Senator Grassley said kind of says it all. "Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA.” Listen to or download the episode here. Show notes, references and more available at https://healthsovereign.com/59/

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Season 2 Episode 4 - Supporting FDA Drug Reviews With Data Insights

HealthCast

Play Episode Listen Later Dec 11, 2020 17:03

The Food and Drug Administration's Center for Drug Evaluation and Research office has a vital role in the decision-making that regulates medicines. Senior Business Informatics Officer Justin Scott describes how the agency is using digital intelligence tools like ABBYY and automation to modernize the agency's 30 years of archives and support researchers monitoring public health.

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Do FDA Scientists Trust the FDA?

Health Sovereign Podcast

Play Episode Listen Later Dec 1, 2020 7:39

Renee Dufault finds traces of mercury in corn syrup. The FDA tells her not to investigate. Rosemary Johann-Liang wants to place a strong warning label on the drug Avandia. Her superiors transfer away her responsibilities on that drug. David Graham says of the deadly Vioxx, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless...Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.” And that’s just the start. This episode also features the FDA spying, a criminal investigation of the head of the FDA, and even more whistleblowers. What Senator Grassley said kind of says it all. "Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA.” Show notes, references and more available at https://healthsovereign.com/57/

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An Update from Operation Warp Speed

New England Journal of Medicine Interviews

Play Episode Listen Later Nov 11, 2020 28:30

Eric Rubin is the Editor-in-Chief of the Journal. Lindsey Baden is a Deputy Editor of the Journal. Janet Woodcock is the director of the Center for Drug Evaluation and Research at the Food and Drug Administration, currently detailed to Operation Warp Speed. She is also a member of the Editorial Board for the Journal. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the Journal. E.J. Rubin and Others. Audio Interview: An Update from Operation Warp Speed. N Engl J Med 2020;383:e127.

Improving Drug Safety

Patients Rising Podcast

Play Episode Listen Later Oct 16, 2020 16:35

Drug pricing continues to make the news, so we’re revisiting our conversation with Dr. Janet Woodcock of the FDA about bringing drug manufacturing back to the U.S. Hear how American-made drugs might lower costs and improve overall safety. Plus, get caught up on this week’s healthcare news headlines in our weekly news roundup.GuestJanet Woodcock, M.D. Director, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA)Since Dr. Janet Woodcock joined the FDA in 1986, she has led numerous FDA drug initiatives while maintaining the reliability of the FDA’s regulatory process. She worked to incorporate risk management practices into evaluating drug safety and has taken the lead on efforts to update drug manufacturing procedures and regulations, known as the “Pharmaceutical Quality for the 21st Initiative.”Dr. Woodcock also recently launched two new drug safety initiatives to improve safety management and regulation both within and outside the FDA. Currently, Dr. Woodcock is the Director of the Center for Drug Evaluation and Research (CDER) which ensures the effectiveness of drugs, provides data and instructions to health care providers and patients, and monitors clinical trials of new drugs. Dr. Woodcock received her bachelor’s degree in chemistry from Bucknell University in Lewisburg, Pennsylvania, and her doctor of medicine degree from the Feinberg School of Medicine at Northwestern University Medical School in Chicago, Illinois. Hosts:Terry Wilcox, Executive Director, Patients RisingDr. Robert Goldberg, “Dr. Bob”, Co-Founder and Vice President of the Center for Medicine in the Public Interest.Kate Pecora, Field Correspondent Links:Patients Rising Concierge Need help?The successful patient is one who can get what they need when they need it. We all know insurance slows us down, so why not take matters into your own hands. Our Navigator is an online tool that allows you to search a massive network of health-related resources using your zip code so you get local results. Get proactive and become a more successful patient right now at PatientsRisingConcierge.orgHave a question or comment about the show, want to suggest a show topic or share your story as a patient correspondent?Drop us a line: podcast@patientsrising.orgThe views and opinions expressed herein are those of the guest(s)/ author(s) and do not reflect the official policy or position of Patients Rising.

Innovative Trial Design & Master Protocols: Lisa Lavange | Pod of Asclepius

Data & Science with Glen Wright Colopy

Play Episode Listen Later Sep 9, 2020 44:50

Lisa LaVange (Gillings School of Global Public Health at the University of North Carolina at Chapel Hill) was the 2018 American Statistical Association (ASA) president and the director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER) at the FDA. She give a high-level overview of issues surrounding Innovative Trial Design and Master Protocols. A great listen for anyone wanting to be introduced to the subject or (for those already familiar) interested in its growing breadth of applications. #datascience #statistics #biopharm #pharma #FDA

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Drug Shortages and COVID-19

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Play Episode Listen Later Aug 25, 2020 9:18

Valerie Jensen, the Associate Director of the Drug Shortages staff in FDA's Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on drug shortages and how the COVID-19 pandemic can impact the drug supply chain.

A “Topical” Discussion on Sunscreen

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Play Episode Listen Later Aug 4, 2020 11:00

During the summer, fun in the sun is a high priority for many families, but what do you really know about that sunscreen protecting you? Dr. Terri Michele, the Director of the Office of Non-Prescription Drugs in FDA’s Center for Drug Evaluation and Research, joins Dr. Shah to discuss sunscreen safety.

#119 - Dr. Steven Galson

KGI: Innovation in Applied Life Sciences & Healthcare

Play Episode Listen Later Jul 15, 2020 56:12

As part of the Pandemic Solutions: Virtual Speaker Series, KGI’s Rajesh Parti interviewed Dr. Steven Galson, Senior Vice President of Global Regulatory Affairs and Safety at Amgen. Dr. Galson has more than 20 years of experience in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation.

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Clinical Trials and Treatments for COVID-19

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Play Episode Listen Later Jul 14, 2020 15:59

Dr. Patrizia Cavazzoni, the acting director of FDA’s Center for Drug Evaluation and Research, joins Dr. Shah for an in-depth discussion on clinical trials and treatments for COVID-19. A list of clinical trials are available at https://clinicaltrials.gov.

Screening for esophageal adenocarcinoma in patients with GERD — a clinical practice guideline

CMAJ Podcasts

Play Episode Listen Later Jul 6, 2020 17:39

Dr. Scott Klarenbach shares the key messages out of a new clinical practice guideline on screening for esophageal adenocarcinoma in patients with chronic gastroesophageal reflux disease. Dr. Klarenbach is a professor in the Department of Medicine, and Assistant Dean, Health Outcomes at the University of Alberta. He is currently Chair of the Alberta Expert Committee on Drug Evaluation and Therapeutics and member of the Canadian Task Force on Preventative Health Care. The guideline is published in CMAJ: www.cmaj.ca/lookup/doi/10.1503/cmaj.190814 ----------------------------------- Subscribe to CMAJ Podcasts on Apple Podcasts, iTunes, Google Play, Stitcher, Overcast, Instacast, or your favourite aggregator. You can also follow us directly on our SoundCloud page or you can visit www.cmaj.ca/page/multimedia/podcasts.

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Safer + Cheaper Drugs

Patients Rising Podcast

Play Episode Listen Later Jun 12, 2020 31:46

Made in the USA: The return of drug manufacturing to the U.S. could help improve drug safety, cost, and accessibility for patients with chronic disease. Dr. Janet Woodcock is director of the FDA’s Center for Drug Evaluation and Research. She tells us about new technologies and processes to make this possible. Also, Dr. Bob celebrates his birthday by looking into Medicare options. Field correspondent Kate Pecora speaks with Mark Olsen, who describes the challenges of securing adequate healthcare and education for his son who lives with a rare disease. Guest: Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) Since Dr. Janet Woodcock joined the FDA in 1986, she has led numerous FDA drug initiatives while maintaining the reliability of the FDA’s regulatory process. She has worked to incorporate risk management practices into evaluating drug safety and has taken the lead on efforts to update drug manufacturing procedures and regulations, an effort known as the “Pharmaceutical Quality for the 21st Initiative.” Dr. Woodcock also recently launched two new drug safety initiatives to improve safety management and regulation. In her current position, Dr. Woodcock’s organization works to ensure the effectiveness of drugs, provides data and instructions to health care providers and patients, and monitors clinical trials of new drugs. Dr. Woodcock received her bachelor’s degree in chemistry from Bucknell University in Lewisburg, Pennsylvania, and her Doctor of Medicine degree from the Feinberg School of Medicine at Northwestern University Medical School in Chicago. Hosts: Terry Wilcox, Executive Director, Patients Rising Dr. Robert Goldberg, “Dr. Bob”, Co-Founder and Vice President of the Center for Medicine in the Public Interest. Kate Pecora, Field Correspondent Links: Asymptomatic spread of Coronavirus is ‘very rare,’ WHO says Manufacturing API, Drugs and Excipients (MADE) in America Act Patients Rising Concierge Need help? The successful patient is one who can get what they need when they need it. We all know insurance slows us down, so why not take matters into your own hands. Our Navigator is an online tool that allows you to search a massive network of health-related resources using your zip code so you get local results. Get proactive and become a more successful patient right now at PatientsRisingConcierge.org Have a question or comment about the show, want to suggest a show topic or share your story as a patient correspondent? Drop us a line: podcast@patientsrising.org The views and opinions expressed herein are those of the guest(s)/ author(s) and do not reflect the official policy or position of Patients Rising.

FDA Regulation of Botanicals – Tara Berman, MD

Integrative Oncology Talk

Play Episode Listen Later Jun 8, 2020 62:44

In this podcast, we learn about the origins of the FDA, how the FDA regulates botanicals, and how the FDA can provide guidance on natural product research and clinical trials. Dr. Tara Berman, an oncologist for the Breast/Gyn Malignancies Team in the Office of Oncologic Diseases at Center for Drug Evaluation and Research (CDER) in the FDA, serves as the integrative oncology liaison for the division. Dr. Berman also holds a Master of Science in Nutrition.

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CD213: CARES Act - The Trillions for COVID-19 Law

Congressional Dish

Play Episode Listen Later Apr 27, 2020 149:56

The U.S. Treasury has been legally robbed! In this episode, discover the secret provisions in the multi-trillion dollar CARES Act that no one is talking about (like the new process for over the counter drug approvals) and discover the reasons behind problems that everyone is talking about (like why Mom & Pops can't get a small business loan approved but Fogo de Chao can.) The good news is that the problems are so obvious that they are easily fixed... If Congress ever comes back from vacation. Please Support Congressional Dish – Quick Links Click here to contribute monthly or a lump sum via PayPal Click here to support Congressional Dish for each episode via Patreon Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank’s online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536 Please make checks payable to Congressional Dish Thank you for supporting truly independent media! Recommended Congressional Dish Episodes CD160: Equifax Breach CD199: Surprise Medical Bills CD201: WTF is the Federal Reserve? CD212: The COVID-19 Response Laws Bills H.R.748 - CARES Act Text: H.R.748 - CARES Act Roll Call: H.R.748 - CARES Act House passed by voice vote at 1:25pm on March 27th Transcript: House debate Tom Massie demanded a recorded vote but an insufficient number of members supported him and the demand for a recorded vote was refused Signed by Trump on March 27 CARES Act Outline DIVISION A - Keeping Workers Paid and Employed, Health Care System Enhancements, and Economic Stabilization TITLE I - Keeping American Workers Paid and Employed Act Sec. 1102: "Paycheck Protection Program" (Small Business Loans) The Federal Government will guarantee 100% of the loans made under this authority between February 15, 2020 and June 30, 2020. The loans are allowed to be used by businesses to pay for their employees salaries, tips, sick and vacation time, health care, retirement benefits, and state and local taxes. Sole proprietors and independent contractors are eligible. All payments are capped at a salary rate of $100,000/yr per individual. Payments are not eligible for employees who live outside the United States, even if they are US citizens. A “small business” is defined as a business with fewer than 500 employees per physical location. Usually, franchises in a large corporate chain would be except from receiving these loans, but that exemption is waived. Nonprofits and veterans organizations are eligible as well. The maximum loan amount is $10 million. No personal guarantee or collateral can be required to get the loans between February 15, 2020 and June 30, 2020. There are no penalties allowed for prepayment of the loans. The Federal government will collect no administration fees. Interest rates are capped at 4% Fees for banks: The government will pay the bankers processing fees of 5% for loans under $350,000, 3% for loans between $350,000 and $2 million, and 1% of loans over $2 million. Loan payments must be allowed to be deferred - so no required payments of principal, interest, or fees - for at least 6 months and up to one year. The loans are allowed to be sold on the secondary market, but if the investor doesn’t want to abide by the deferment requirements, the government can buy the loan. Banks are going to be exempted from some disclosure requirements for these loans. The law authorizes $349 billion for this program. Sec. 1106: The loans from Section 1102 are eligible for forgiveness - as in you don’t have to pay them back - if the loan money was used for payroll costs, interest-only on mortgage payments (it specifically excludes payments towards the principal on a mortgage loan), rent payments, and/or utility payments. The government will pay the bankers for amount of the loan forgiven plus interest, capped at the amount of the principal on the loan. The amount of loan forgiveness will be reduced if the business employees fewer people during the COVID-19 crisis than they did before. The amount of forgiveness will be reduced by the amount of salary that employees who make less than $100,000/yr have their pay reduced beyond a 25% cut. Businesses can get loan forgiveness for extra money given to tipped employees. Businesses who re-hire their employees or re-instate employees salary to their pre-crisis level by June 30, 2020 will be eligible to have their loans forgiven. The banks will decide who will have their loans forgiven and banks are prohibited from being punished if the documentation submitted to them is wrong until June 30, 2020. Sec. 1110: From January 31, 2020 through December 31, 2020, businesses with fewer than 500 employees, sole proprietorships, and independent contractors can request a $10,000 advance to pay for employee sick leave, payroll, increased costs for materials, rent, or mortgage payments. The business can be approved using a credit score or self certification of the ability to repay. The advance can be up to $10,000 and must be paid within 3 days. If the applicant is approved for a loan, the advance will be reduced from the loan forgiveness amount. If the applicant isn’t approved, the advance doesn’t have to be repaid. $10 billion is appropriated for the advances. Sec. 1112: The government will pay the principal, interest, and fees for six months on some existing loans that are guaranteed by the government by the Small Business Act. $17 billion is appropriated for these payments. Sec. 1113: Until March 27, 2021, small businesses that want to declare bankruptcy and reorganize under Chapter 11 must have debts under $7.5 million instead of $2,725,625 as is usually the case, which increases the number of small businesses that will be eligible. TITLE II - Assistance for American Workers, Families, and Businesses SUBTITLE A: Unemployment Insurance Provisions Sec. 2102: Pandemic Unemployment Assistance Who qualifies: People who would qualify under existing State laws People who self-certify that are able to work except that the person has been diagnosed with COVID-19, someone in their home has been diagnosed with COVID-19, they are caring for someone with COVID-19, has a child whose daycare or school is closed due to COVID-19, can’t get to work because of a COVID-19 quarantine, their work is closed due to COVID-19, or they are self employed. People who do not qualify are people who have the ability to telework with pay or people who are receiving paid sick leave or other paid leave benefits Effective period: Beginning on or after January 27, 2020 and ending on or before December 31, 2020 Limits: No one can get unemployment benefits for more than 39 weeks, but this can be extended by the Secretary of Labor if needed Sec. 2104: Unemployment Amounts: It’s the amount determined by your state’s unemployment law plus $600 per week if the state chooses to enter into an agreement with the Secretary of Labor. The Federal government will pay for 100% of the costs of the extra unemployment payments and the administration costs. It’s an unlimited appropriation and it’s valid until July 31, 2020. SUBTITLE B: Rebates and Other Individual Provisions Sec. 2201: Issues a means tested “advanced refund" of $1,200 per adult and $500 per child. You only get the full amount as an adult if you make $75,000 per adult or less. People who make more than $75,000 per adult will have their check amount reduced based on their income up to about $100,000. People who make more than that will get nothing. The payment will be delivered via direct deposit to anyone who has authorized the IRS to do so since January 1, 2018 while everyone else will have to wait for checks. If we accidentally get overpaid, the IRS can’t charge us interest on that payment. The payments will be made for the 2019 tax year if you have already done your taxes for last year. If you haven’t, it’ll be based on 2018. They will send a notification in the mail to us about our payments to our last known address, which will tell us the amount and if it’s going to be delivered via direct deposit or by check. Sec. 2202: Waives rules that penalize removing money from your retirement accounts if you take the money out between January 1, 2020 and December 31, 2020.. You can take out up $100,000 in “coronavirus-related distributions”. You are allowed to pay it back in full for 3 years starting on the day you took the money out. To qualify, you have to self certify that you are someone who had COVID-19, is caring for a spouse or dependent who had COVID-19, or someone who was financially screwed in some way due to being quarantined, having work hours reduced, or having to care for a child. Sec. 2203: Waives the requirements that people over the age of 72, or their dependents who inherited their retirement accounts, to withdraw some money from the retirement accounts every year. The waiver is valid even for people who were not adversely affected by COVID-19. Sec. 2204: Allows people - even those that don’t itemize their deductions - to deduct $300 in donations in 2020 for cash payments given to charities, a government organization, educational organizations, veterans organizations… There’s a long list. Applies to taxable years starting with 2020. Sec. 2205: For people who do itemize their deductions, the current limit of cash contributions than can be written off (which is a maximum of 60% of the taxpayer’s tax bill for the year) is suspended. You can deduct up to your entire tax bill, although maybe even more because carry-overs are allowed. For corporations, the usual limit of cash contributions that can be written off (10% of the corporation’s income) is increased to 25% of the corporation’s income. The corporate limit increase is valid only in 2020. Sec. 2206: Allows employers to pay for some of an employee’s student loan - principal and/or interest - tax free if the payment is made by January 1, 2021. SUBTITLE C - Business provisions Sec. 2301: Employers with more than 100 employees will be able to get a tax credit for half of the wages they pay to their employee’s who can’t work, with a limit of $10,000 per employee per quarter. Employer with fewer than 100 employees can get the tax credit for all their employees. Employers who qualify are ones that had to close due to COVID-19 or whose gross receipts are less than 50% of what they were the same quarter last year. Employers who take out the small business loans created by this law can’t get this credit too. They will lose this tax credit in the quarter after their gross receipts are more than 80% of what they were in same quarter the prior year. This is predicted to save companies $54.6 billion. Sec. 2302: Allows employers to defer payroll taxes, with half the amount required to be paid by December 31, 2021 and the other half due by December 31, 2022. Businesses that have had loans forgiven using the provisions in this law are not eligible. Sec. 2303: The IRS code has, for many years, allowed business losses to be carried over to following years, so that the companies tax liability will be lower in the years to come. This law changes that so business losses from 2018, 2019, 2020, and 2021 can be carried backwards to each of the five years before the loss while also allowing the existing option to carry the losses forward too. The law also removes the limit that said that this couldn’t be done to offset more than 80% of taxable income for 2018, 2019, or 2020, which means this can be used to zero out their taxable income for years since 2013. This means that companies will be able to get refunds on taxes they paid on taxes going as far back as 2013. In those years, corporate tax rates were higher, so reducing their income levels retroactively lets them get more money back from those higher tax years. There’s no requirement that the businesses that get this tax gift be in any way negatively affected by COVID-19. This is estimated to provide $25.5 billion to corporations Sec. 2304: Prior to the 2017 tax cut law, individual taxpayers could deduct unlimited business losses against other kinds of income. The 2017 tax law changed that so that losses could only be used to shelter the first $250,000 or $500,000 of a married couple’s nonbusiness income, such as capital gains from stock market investments. This law retroactively removes new limits imposed by the 2017 tax law going back to 2018 and until 2021. This will allow individuals to submit amended returns and get refunds that weren’t allowed in 2018 and 2019. In reality, this will allow wealthy investors to use losses generated by depreciation in real estate to minimize their taxes on profits from things like investments in the stock market. No harm from COVID-19 needs to be proven in order to use and benefit from this provision. This is the second largest tax giveaway in this law. This is projected to cost almost $170 billion. Sec. 2305: Allows corporations expecting a refund due to the repeal of the alternative minimum tax in 2017 to get that refund faster. Sec. 2306: Increases the amount corporations can deduct on the interest expenses it pays on its loans from 30% of the company’s “adjusted taxable income” to 50%. Companies can do this regardless of any affect COVID-19 had on their business. This is projected to cost $13.4 billion. Sec. 2307: A tax credit for real estate owners, this changes a provision in the 2017 tax law to allow real estate owners to write off the costs of improvements to the interiors of their properties in the first year instead of spreading them out over many years. This is backdated to the enactment of the tax law, which will allow real estate owners to get tax refunds. Sec. 2308: Waives the federal excise tax on any alcohol used in hand sanitizer for calendar year 2020. TITLE III - Supporting America’s Health Care System in the Fight Against the Coronavirus Part 1 - Addressing Supply Shortages Subpart A - Medical Product Supplies Sec. 3101: Orders a report from the National Academies of Sciences, Engineering, and Medicine on the security of the United States medical product supply chain, specifically by evaluating the dependance of the United States and our private sector on critical drugs and devices sources or manufactured outside of the United States. Sec. 3103: Manufacturers of certain types of masks and ventilators are granted immunity from lawsuits during public health emergencies. Subpart B - Mitigating Emergency Drug Shortages Sec. 3112: Requires the manufacturers of drugs critical to the public health to report interruptions to the supply of the drug when the cause of the interruption is an interruption in the supply of the active pharmaceutical ingredient. They must also create and implement risk management plans. Is not effective until mid-September 2020. Subpart C - Preventing Medical Device Shortages Sec. 3121: Requires manufacturers of medical devices that are critical to public health to report to the government during or in advance of a public health emergency any interruptions in the manufacture of the devices that could lead to a meaningful disruption in the supply of that device in the United States. Unless it’s not possible, the government must get this notification at least 6 months prior to the date that the interruption or discontinuance is expected. The government must then distribute the information to appropriate health care industry officials. The government can keep the information from the public if disclosing it increases the likelihood of over-purchase of the product. Part II - Access to Health Care For COVID-19 Patients Subpart A - Coverage of Testing and Preventive Services Sec. 3201: Amends the Families First Coronavirus Response Act (the 2nd COVID-19 Response Law) so that coverage is only for COVID-19 tests that are “approved, cleared, or authorized” or that the developer has requested or intends to request emergency use authorization, is developed in and authorized by a State, or another test that HHS determines appropriate in writing. This provision did not change the language (loophole) that requires visits be covered only if they “result in the ordering or administration of a COVID-19 test.” Sec. 3202: Health care providers must publish on a public internet website the prices for COVID-19 testing. If health insurers have a negotiated rate with a providers, they are allowed to pay that rate if it is lower than the published rate. If there is no negotiated rate, the insurance companies must pay the amount listed on their public website. Sec. 3203: The health insurance companies “shall” be required to cover, without cost sharing, “any qualifying coronavirus preventive service” (which is “a service or immunization that is intended to prevent or mitigate coronavirus disease 2019) within 15 days of it’s official recommendation by the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. Subpart B - Support for Health Care Providers Sec. 3211: Provides $1.32 billion in extra funding for community health centers that are testing for COVID-19 Sec. 3215: Gives legal immunity in State and Federal courts to medical professionals who volunteer and provide services during the COVID-19 public health emergency declared on January 31, 2020, but the immunity is only valid for actions that took place after March 27th (the date of enactment). The immunity is not valid if the health care professional acted with willful or gross negligence or if the health professional was intoxicated by drugs or alcohol. Subpart C - Miscellaneous Provisions Sec. 3222: Elderly people who are homebound due to social distancing requirements during the COVID-19 emergency will be able to get government food deliveries as if they were homebound due to illness, as the law usually requires. Part III - Innovation Sec. 3301: Allows contracts created by BARDA (the Biomedical Advanced Research and Development Authority) during a public health emergency to continue past the end date of the public health emergency. Sec. 3302: Requires - no option - the Secretary of Health and Human Services to expedite the development and review of new animal drugs if preliminary clinical evidence indicates that the new drug might prevent or treat an animal disease that could cause serious or life-threatening diseases in humans, if the expedited process is requested by the organization creating the animal drug. Part IV - Health Care Workforce Sec. 3401: Appropriates $23.7 million per year through 2025 for grants to health professions schools and other public and nonprofit health or educational organizations, but with most of the grants being funded at significantly lower rates than they were during the Obama years. For example, for loan repayments and fellowships, they provided $5 million/yr during 2010-2014; that’s decreased to $1.2 million for 2021-2025. For educational assistance for people from disadvantaged backgrounds, they provided $60 million/yr during 2010-2014; that’s decreased to $15 million for 2021-2025. For grants to public and nonprofit private hospitals and medical schools, they provided $125 million/yr during 2010-2014; that’s decreased to under $49 million for 2021-2025. For health education center programs, they provided $125 million/yr during 2010-2014; that’s decreased to under $41.2 million for 2021-2025. For public health training centers, they provided at least $43 million/yr for 2012-2015; that’s decreased to $17 million for 2021-2025. The only category that gets significantly greater funding is a pediatric specialty loan repayment program that requires the student to work for at least 2 years in pediatric medicine to get the money. The funding level was $50 million/yr from 2010-2013, the funding is authorized to be unlimited from 2021 through 2025. All of these are authorizations for appropriations, they don’t provide any additional money. Sec. 3403: Requires grants and contracts be awarded for a Geriatrics Workforce Enhancement Program, that would train health professionals in geriatrics. The law authorizes about $40 million, but doesn’t appropriate it. This is a problem because Congress frequently will authorize programs they have no intention of funding, and without the funding, they don’t really exist. Sec. 3404: Authorizes appropriations, but does not appropriate, for nursing eduction programs about $138 million/yr for fiscal years 2021 through 2025, which is a decrease from the funding of $338 million that was valid from 2011-2016. Also authorizes, but does not appropriate, $117 million/yr from 2021-2015 for nursing student loans. Subtitle B - Education Provisions Sec. 3503: Through 2021, the requirement that all colleges match Federal funding for student work-study programs) is waived except for private for-profit organizations. Sec. 3504: Colleges will be allowed to use some of their federal Supplemental Educational Opportunity Grant money for students facing “unexpected expenses and unmet financial need”. The student can be given up to the maximum Federal Pell Grant for that year (which is currently $6,345). Sec. 3505: Allows colleges to pay student their work-study wages up to the full amount they would have been paid had there not been an emergency. They can make the payments in one-time grants or as multiple payments. Sec. 3506: The semester that students with loans couldn’t finish because of COVID-19 will not be counted towards their lifetime limits on subsidized loan eligibility. Sec. 3507: The semester that students with loans couldn’t finish because of COVID-19 will not be counted towards their lifetime limits on Pell Grant eligibility. Sec. 3508: Colleges, including for-profit colleges, that have students with loans withdraw from their schools due to COVID-19 will not have to repay the money they received from that student. The students will not have to return the money either and their loan obligation will be cancelled. The schools are allowed to let the student return after a leave of absence. Sec. 3511: Gives the Secretary of Education the option, at the request of a State, local, or tribal government, to waive statutory and regulatory requirements except for civli rights laws. The waivers may also be granted to charter schools. The waivers will not be valid past the 2019-2020 school year. Sec. 3512: During the COVID-19 emergency, the Secretary of Education can make payments - including on principal and interest - on loans issued to historically black colleges and universities through the HBCU Capital Financing Loan program, but the payments will have to be repaid to the Department of Education no sooner than one year after the COVID-19 emergency ends. The law appropriates $62 million. Sec. 3513: The Secretary of Education is required to suspend all payments due for student loans until September 30, 2020. Interest is not allowed to accrue during the suspension time. Each month during the suspicion must be treated as if the payments were made for the purpose of loan forgiveness programs. During the suspension period, student loan collections actions including wage garnishment and tax refund reductions must stop. People with student loans are allowed to keep making payments towards their principal. Sec. 3518: Allows the Secretary of Education to change the requirements, including matching requirements, for grant money given to colleges for the year of the emergency and the following fiscal year. Sec. 3519: Allows the Secretary of Education to excuse teachers from obligations they made to receive grants. The Secretary of Education is required to waive requirements that teaching service be consecutive for loan forgiveness as long as the teach completes a total of 5 years of required teaching service. Subtitle C - Labor Provisions Sec. 3606: Allows employers who will get a credit for the sick and family leave they are providing their employees to get that credit in advance. Sec. 3608: Required payments to employee pension plans can be postponed until January 1, 2021, but they must be paid with interest. Sec. 3610: Allows any government agency to change their contracts to allow the government to pay for up to 40 hours per week of paid leave that a contractor provides to its employees until September 30, 2020. This only applies to contractors who can’t work because the facilities where they work are closed and who can’t do their work remotely. Subtitle D - Finance Committee Sec. 3701: High deductible health insurance plans that do not include deductibles for telehealth services will still be considered high deductible plans. Sec. 3702: Starting on January 1, 2020, menstrual care products are considered medical products, which allows people to purchase them with Health Savings Accounts. Sec. 3703: Allows people on Medicare to be covered for telehealth visits to doctors they have not seen before. Sec. 3705: During the COVID-19 emergency, dialysis patients who receive their treatments at home do not need to meet face to face with their doctors, which allows the visit to be conducted via telehealth. Sec. 3706: The Secretary of Health and Human Services can allow hospice physicians or nurse practitioners to conduct patient visits via telehealth during the COVID-19 emergency Sec. 3709: Stops the 2% Medicare sequestration from May 1, 2020 through December 31, 2020, but extends sequestration for an extra year (to 2030 instead of 2029) Sec. 3710: Medicare will pay an extra 20% for people diagnosed with COVID-19, using “diagnosis codes, condition codes, or other such means as may be necessary” during the emergency period declared by the Secretary of Health and Human Services. Sec. 3713: Beginning on the day that a COVID-19 vaccine is licensed, Medicare will not charge a deductible for the the vaccine or its administration. Sec. 3714: Allows people on Medicare to get 90 day supplies of their drugs in a single refill for the during of the COVID-19 emergency declared by the HHS Secretary. Sec. 3719: During the emergency period, the Secretary of HHS can loan hospitals an advance of up to 6 months of Medicare payments. The payments can be made periodically or in a lump sum for up to 100% of the their usual payments, 125% for critical access hospitals. Hospitals will have to be given 120 days before any payments are decreased to offset the loans and must be given at least 1 year from the date of their first loan receipt to pay back the balance in full. Subtitle E: Health and Human Services Extenders Part I - Medicare Provisions Sec. 3803: Restores the funding levels of recently gutted low income programs. $13 billion to state health insurance programs, $7.5 billion to area agencies on aging, and $5 billion for aging and disability resources centers, and $12 billion for the National Center for Benefits and Outreach Enrollment. Part II - Medicaid Provisions Sec. 3813: Delays $4 billion in payment cuts to hospitals written into the Affordable Care Act which were supposed to begin in 2014. Hospitals were expected to be treating fewer uninsured individuals when the cuts were written into law. Part III - Human Services and Other Health Programs Sec. 3821: Extends the “Sexual Risk Avoidance Education Program” (abstinence eduction) from its scheduled end of May 22, 2020 to November 30, 2020. The program gives grants to states that agree to promote abstinence-only sex ed. Requirements and funding levels Sec. 3822: Extends the “Personal Responsibility Education Program” from its scheduled end of May 22, 2020 to November 30, 2020. Requirements and funding Part IV - Public Health Provisions Sec. 3831: Adds $1.5 billion to the funding for Community Health Centers to bring the funding to equal the 2019 funding, and funds them at the same rate through November 30, 2020. Adds $241 million to the funding for the National Health Service Corps, whose funding was allowed to lapse in December 2019, restoring its funding to equal the 2019 funding. Adds $45 million to teaching health centers that operate graduate medical programs to bring the funding to equal the 2019 funding, and funds them at the same rate through November 30, 2020. Subtitle F - Over the Counter Drugs Part 1 - OTC Drug Review Sec. 3851: Creates a new process for FDA approval of over the counter drug applications. Allows the Secretary of Health and Human Services to issue administrative orders to approve changes and new uses of over the counter drugs instead of requiring drug companies to go through the standard review process that takes longer. Companies whose applications are approved will get 18 month exclusivity on their drugs. Sec. 3854: Allows sunscreen companies with products affected by a pending FDA order to request that the HHS Secretary instead use the new, faster, less complete administrative order process created by Section 3851 for over the counter drugs. They must make this request by mid September 2020. Administrative orders issued by the HHS Secretary will be “deemed to be a final order”. As part of this process, the company may request and the HHS Secretary must conduct a “confidential meeting” with the company to discuss what data they should submit to show that their ingredients are safe and effective. Part II - User Fees Sec. 3862: Beginning in fiscal year 2021, to fund the new processes for over the counter drug approvals created by Section 3851, facilities that manufacture over the counter drugs will be assessed an annual fee and there will be either a $500,000 or $100,000 fee for requests to change drug monographs using the process created by Section 3851. Companies will not have to pay the fee if they are requesting changes to enhance warnings or instructions on the labels. TITLE IV - Economic Stabilization and Assistance to Severely Distressed Sectors of the United States Economy Subtitle A - Coronavirus Economic Stabilization Act of 2020 Sec. 4002: Defines a “covered loss” as “losses directly or indirectly as a result of coronavirus, as determined by the Secretary”, with “the Secretary” being Treasury Secretary Steven Mnuchin. “Eligible business” is an air carrier or “a United States business that has not otherwise received adequate economic relief in the form of loans or loan guarantees provided under this Act” Sec. 4003: Gives the Secretary of the Treasury the authorization to “make loans, loan guarantees and other investments” to "eligible businesses”, States, and local governments up to a total of $500 billion dollars. $46 billion must be directed at the airline industry and $454 billion will be loans, loan guarantees, and “other investments” determined by the Board of Governors of the Federal Reserve. Sec. 4004: Limits the amount of money that an employee of a business that gets a Treasury Department loan to $3 million plus half of whatever they got over $3 million in 2019 for the length of the loan plus one year. Sec. 4005: Until March 1, 2022, the Secretary of Transportation will have the authority to require any airline that takes loan money to maintain their flight schedules, as the Secretary of Transportation determines is needed. Sec. 4007: Suspends a 7.5% Federal excise tax on airlines from March 27, 2020 through the end of the year. Sec. 4008: Amends the Dodd Frank Wall Street Reform law to allow the FDIC to provide insurance for all accounts of banks that don’t accrue interest until December 31, 2020. Sec. 4009: Between March 13, 2020 and either the end of the COVID-19 emergency or December 31, 2020, the Board of Governors of the Federal Reserve is exempt from requirements that they give the public a day’s notice before their meetings and that they make public the minutes of their behind closed doors meetings. They must only keep a record of their votes and reasons for their votes which might be released to the public later (there’s no requirement that they be released). Sec. 4011: Allows unlimited lending to “nonbank financial institutions” such as insurance companies, venture capitalists, currency exchanges, and pawn shops until the end of the emergency declared on March 13 or until December 31, 2020. Sec. 4012: Lowers the amount of actual money that community banks must have in their possession from 9% to 8%, and gives the banks with less than that a “reasonable grace period” to get the money. This is valid until the end of the emergency declared on March 13 or until December 31, 2020. Sec. 4013: Allows banks to avoid counting troubled loans as troubled on their balance sheets from March 1, 2020 through December 31, 2020 or 60 days after the emergency declared on March 13th ends. Sec. 4014: Exempts banks from relatively new reporting requirements on their credit losses from March 27, 2020 through the end of the emergency declared on March 13 or December 31, 2020. Sec. 4015: Allows the Treasury Department to use its Exchange Stabilization Fund (which had $93.7 billion in it as of February 2020) to get around needing Congressional appropriations to cover any losses the Federal Reserve may need to absorb through its lending programs that allow unusual collateral to be offered like money market funds, corporate bonds, and securities. Sec. 4017: Increases the President’s power to use the Defense Production Act by waiving the requirement for Congressional authorization for projects that cost more than $50 million for two years and waives the requirement that Congress needs 30 days advanced notice before a Defense Production Act project can start for 1 year. Sec. 4018: Creates an Inspector General within the Treasury Department who will be appointed by the President. Says that when the Inspector General requests information, the agencies “shall, to the extent practicable” give him the information or else they will be reported to Congress. Sec. 4019: Prohibits loans or payments originating from the Treasury and Federal Reserve authorized by Section 4003 from going to any company in which the President, Vice President, an executive department head, member of Congress or their spouses, children, or son/daughter in laws own over 20% of the voting stock. Sec. 4020: Creates a Congressional Oversight Commission whose job is to conduct oversight of the implementation of this law by the Treasury Department and Federal Reserve. The commission will have five members: 1 appointed by the Speaker of the House (Nancy Pelosi), 1 appointed by the House minority leader (Kevin McCarthy), 1 appointed by the Senate majority leader (Mitch McConnell), 1 appointed by the Senate minority leader (Chuck Schumer), and 1 Chairperson co-appointed by the Speaker and Majority Leader (Pelosi and McConnell). Sec. 4021: Companies that allow customers to adjust their payment schedules have to report that the customer is current on their payments unless their accounts are already delinquent. This is valid from January 31, 2020 through either the end of July 2020 or 4 months after the emergency declared on March 13th ends Sec. 4022: People with Federally backed mortgages who have been affected by COVID-19 “directly or indirectly” can request and must be granted for a pause in loan payments for a maximum of about a year, but you have to request it twice (again after the first 180 days). Interest and fees will still accrue but they can’t charge any extra interest, penalties, or fees. Customers have to provide no proof of hardship. Prohibits the banks that manage Federally backed loans from moving forward with any foreclosure processes until mid-May 2020 (60 days after March 18, 2020). Sec. 4023: People/companies that own multifamily housing with 5 or more units with Federally backed mortgages who have been affected by COVID-19 “directly or indirectly” can request and must be granted for a pause in loan payments. The forbearance (pause) can be for a total of 90 days as long as the building owner requests it three times with at least 15 days notice. People who get this pause are not allowed to evict their tenants or charge them any late fees during the mortgage payment pause. Sec. 4024: Starting on March 27, 2020 and ending in late July 2020, landlords can not begin eviction proceedings for non-payment of rent or charge fees or penalties for not paying rent. Sec. 4025: Prohibits the government from attaching a string to a loan or loan guarantee that requires the business to negotiate with unions over worker pay or conditions of employment. This is valid starting on the day the business is first issued the loan and ending a year after the loan is paid off. Sec. 4026: Within 72 hours of each transaction, the Treasury Secretary must publish on the Treasury Department website a description of the transaction, the date, and the “identity of the counterparty”, the amount of the loan/guarantee/investment, how the price was determined, the interest rate, conditions, and a copy of the final term sheet. The Treasury Secretary also has to report any contracts entered into for the administration of loans or guarantees within 24 hours after the contract is entered into. The Federal Reserve has to issue reports to Congress that will have to be made public on their website within 7 days of the report being delivered to Congress. Sec. 4027: Appropriates $500 billion Sec. 4029: The authorities given to the Treasury Secretary and Board of Governors of the Federal Reserve to make loans, loan guarantees, and “investments” in businesses and banks will expire on December 31, 2020. Subtitle B - Air Carrier Worker Support Sec. 4112: The Secretary of the Treasury “shall” give money to airlines and the contractors that work with them which “shall exclusively be used for the continuation of payment of employee wages, salaries, and benefits”. Passenger air carriers will get $25 billion, cargo airlines $4 billion, and contractors will get $3 billion. Sec. 4113: The employees will have to be paid whatever rate they were paid from April 1, 2019 through September 30, 2019. Steven Mnuchin will decide all terms and conditions, other than the ones set by section 4114, 4115, and 4116. The payments have to start to be made within 10 days of enactment. The Inspector General of the Treasury Department will have to audit the certifications made by the companies about employee salary and benefit rates. Sec. 4114: Airlines or contractors that take the money can’t furlough their workers or reduce their wages or benefits until September 30, 2020, they can’t buy stock in their company or parent company, or pay out dividends. The Secretary of Transportation is also given authorization until March 1, 2022 to require only airlines or contractors that take the money to continue service to anywhere that they served as of March 1, 2020. Sec. 4115: Prohibits the government from attaching a string to a loan or loan guarantee that requires the airline or contractor to negotiate with unions over worker pay or conditions of employment. This is valid starting on the day the business is first issued the loan and ending on September 30, 2020. Sec. 4116: From March 24, 2020 through March 24, 2022, any airline or contractor that takes the money has to agree that no employee who made more than $425,000 in 2019 will be paid more than what they were paid in 2019, or will receive more than double their 2019 pay as a severance package. Employees that were paid more than $3 million can’t be paid more than $3 million plus half of the amount they were paid over $3 million in 2019. This includes salary, bonuses, stock awards and “other financial benefits”. Sec. 4117: The Treasury Secretary is allowed, but not required, to accept stock and securities and other “financial instruments” from the airlines and contractors. Sec. 4120: Appropriates $32 billion. TITLE V - Coronavirus Relief Funds Sec. 5001: Appropriates $150 billion for State, tribal and local governments. Amounts will be determined by population but each state will get at least $1.25 billion. Washington D.C. is treated as a territory and all territories will split $3 billion. Tribal governments will split $8 billion. Steven Mnuchin will decide how the tribal government money will be divided. The Inspector General of the Treasury must investigate the receipt, disbursement, and use of funds. TITLE VI - Miscellaneous Provisions Sec. 6001: Allows the Postal Service to borrow $10 billion from the Treasury Department. Division B - Emergency Appropriations for Coronavirus Health Response and Agency Operations Bureau of Prisons Sec. 12003: The Secretary of Health and Human Services “shall appropriately consider” distributing personal protective equipment and test kits to the Bureau of Prisons for use by inmates and staff. Sec. 12005: Authorizes and appropriates $300 million that the Secretary of Commerce can use for direct payments to subsistence, commercial, and charter fishery businesses. Department of Energy Sec. 14002: Extends the authority for the Secretary of Energy to sell oil from the strategic petroleum reserve and gives the Department of Energy the authority to sell $900 million worth of oil from the Strategic Petroleum Reserve, $450 million in 2021 and 2022, on top of the $450 million they can sell in 2020. The Judiciary Sec. 15002: Allows for criminal proceedings to be conducted via video teleconferencing until 30 days after the national emergency declaration terminates. It will only be allowed with the consent of the defendant or juvenile after they talk to a lawyer. Election Security Grants Provides $400 million to prepare for the 2020 Federal election cycle, domestically or internationally. The money must be given by the Election Assistance Commission to the states within 30 days. There is no direction on how the money is divided among states. The states have to submit reports on how they use the money. Money not used by December 31, 2020 has to be returned to the Treasury. Pandemic Response Accountability Committee Sec. 15010: Creates a Pandemic Response Accountability Committee that will investigate and report on the use of COVID-19 funds through September 2025. The committee will be operated by two full time paid employees and the other members will be inspectors generals from at least 9 federal agencies. The committee will have enforceable subpoena power. The committee is allowed, but not required, to hold public hearings. The committee will have a public website that is required to provide their findings, data, some contracting information, division of COVID-19 funds by state and congressional district, agency plans for use of funds, all recommendations made to the agencies, etc. Department of Homeland Security Sec. 16004: Prohibits the Department of Homeland Security from transferring War on Terror funds for the COVID-19 efforts. Sec. 16006: The Secretary of Homeland Security must extend the REAL-ID deadline until at least September 30, 2021. Department of Health and Human Services Public Health and Social Services Emergency Fund Provides an additional $27 billion for “developing necessary countermeasures and vaccines, prioritizing platform-based technologies with US based manufacturing capabilities, the purchase of vaccines, therapeutics, diagnostics, and necessary medical supplies”. Products purchased by the Federal government must be purchased in accordance with regulations on fair and reasonable pricing, ensuring affordability in the commercial market is optional. The HHS Secretary can not take any action that would slow down the development of the products. $16 billion can be spent on purchasing items for the Strategic National Stockpile. Funds can be used to construct or renovate “US based next generation manufacturing facilities, other than facilities owned by the United States government” in addition to the authority to construct or renovate private facilities that manufacture vaccines, therapeutics, and diagnostics. Adds an additional $100 billion to reimburse health care providers - public, private, and for profit - for COVID-19 expenses. Sec. 18115: Every lab that performs or analyzes a COVID-19 test must report the result of each test to the Secretary of Health and Human Services until the end of the HHS Secretary’s public health declaration with respect of COVID-19. State Department Sec. 21012: Provides $3 billion for the International Development Association (World Bank), $7.3 billion for the African Development Bank, and authorizes the Treasury “to make loans in an amount not to exceed the dollar equivalent 28,202,470,000 of Special Drawing Rights (which is approximately $38.5 billion as of April 21, 2020) OTC Drugs Bill Information Article: H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, Congress.gov Article: S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, Congress.gov Article: Roll Call Vote 116th Congress - 1st Session On Passage of the Bill (S. 2740), United States Senate, December 10, 2019 Bill Profile: H.R.3443: Clients Lobbying on H.R.3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, OpenSecrets.org Bill Profile: H.R.3443: Lobbyists lobbying on H.R.3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, OpenSecrets.org Sen. Johnny Isakson - Georgia: Top Industries 1995 - 2020, OpenSecrets.org Sen. Lamar Alexander - Tennessee: Top Industries 1995 - 2020, OpenSecrets.org Articles/Documents Update: Message from Jennifer Roberts, CEO of Chase Business Banking Chase Banking, April 23, 2020 Article: Hard-hit restaurants, gyms and other businesses are battling insurers over the coronavirus, sparking a new Washington lobbying war By Tom Hamburger and Tony Romm, The Washington Post, April 22, 2020 Article: Pelosi says Shall will stay on oversight commission after failure to disclose stock sales by Jeremy Herb and Lauren Fox, CNN, April 22, 2020. Article: Vaccine Chief Says He Was Removed After Questioning Drug Trump Promoted The New York Times, April 22, 2020 Article: Highlights of the Nearly $500B Coronavirus Relief Bill The New York Times, April 21, 2020 Article: Publicly traded firms get $365M in small-business loans By REESE DUNKLIN, JUSTIN PRITCHARD, JUSTIN MYERS and KRYSTA FAURIA, Associated Press, April 21, 2020 Article: Restaurants’ bailout problem: Unemployment pays more By IAN KULLGREN, Politico, April 20, 2020 Article: Medical Staffing Companies Cut Doctors’ Pay While Spending Millions on Political Ads By Isaac Arnsdorf, ProPublica, April 20, 2020 Article: The coronavirus could force more doctors to sell — or shutter By Bob Herman, Axios, April 20, 2020 Article: Chase and other banks shuffled Paycheck Protection Program small business applications, lawsuit says By Dalvin Brown, USA Today, April 20, 2020 Article: Shake Shack returning $10 million government loan meant for small businesses By Stephanie Ruhle and Alex Johnson, NBC News, April 20, 2020 Article: WTI crude price goes negative for the first time in history By Cameron Wallace, World Oil, April 20, 2020 Article: In Race for Small-Business Loans, Winning Hinged on Where Firms Bank By Ruth Simon and Peter Rudegeair, The Wall Street Journal, April 20, 2020 Article: Zoom's Security Woes Were No Secret to Business Partners Like Dropbox By Natasha Singer and Nicole Perlroth, The New York Times, April 20, 2020 Article: A raw deal By Judd Legum, Popular Information, April 20, 2020 Article: The Trickle-Up Bailout By Matt Taibbi, Taibbi, April 17, 2020 Article: Donna Shalala Selection Makes a Mockery of Bailout Oversight Panel by David Dayen, The American Prospect, April 18, 2020. Press Release: Pelosi Appoints Congresswoman Donna Shalala to Congressional Oversight Commission of the CARES Act, April 17, 2020. Article: Ruth’s Chris Steak House Gets $20 Million From Coronavirus Aid Program By Charity L. Scott, The Wall Street Journal, April 17, 2020 Article: The COVID-19 Bailout That’s Left Every Hospital Unhappy In Its Own Way By Rachana Pradhan and Lauren Weber, Kaiser Health News, April 16, 2020 Article: I’m Overseeing the Coronavirus Relief Bill. The Strings Aren’t Attached. By Bharat Ramamurti, The New York Times, April 16, 2020 Article: House lawmakers indefinitely postpone return to Washington By Mike Lillis and Scott Wong, The Hill, April 16, 2020 Article: Paycheck Protection Program out of money: Thousands of small businesses shut out By Stephen Gandel, CBS News, April 16, 2020 Article: Here Are the Contracts Showing How $4.5 Trillion in Stimulus Was Outsourced to Wall Street By Pam Martens and Russ Martens, Wall Street on Parade, April 16, 2020 Article: Most Patients Undergoing Ground And Air Ambulance Transportation Receive Sizable Out-Of-Network Bills By Karan R. Chhabra, Keegan McGuire, Kyle H. Sheetz, John W. Scott, Ushapoorna Nuliyalu, and Andrew M. Ryan, HealthAffairs, April 15, 2020 Article: Renters Are Being Forced From Their Homes Despite Eviction Moratoriums Meant to Protect Them By Alana Semuels, Time, April 15, 2020 Article: One Person is Overseeing Congress's Bailout Loans. He Wants Answers. by Alan Rappeport, New York Times, April 15, 2020. Article: Policy Memo: Federal Reserve Lending Facilities for Private Companies and Securitizations Americans for Financial Reform, April 15, 2020 Article: Hedge Fund Managers Claiming Bailouts as Small Businesses By Katherine Burton and Joshua Fineman, Bloomberg, April 14, 2020 Article: Rural hospitals shut out of stimulus loans face financial crisis By Rachel Roubein, Politico, April 14, 2020 Article: Tax change in coronavirus package overwhelmingly benefits millionaires, congressional body finds By Jeff Stein, The Washington Post, April 14, 2020 Article: WHITEHOUSE, DOGGETT RELEASE NEW ANALYSIS SHOWING GOP TAX PROVISIONS IN CARES ACT OVERWHELMINGLY BENEFIT MILLION-DOLLAR-PLUS EARNERS Sheldon Whitehouse, U.S. Senator for Rhode Island, April 14, 2020 Article: Your Coronavirus Check Is Coming. Your Bank Can Grab It. By David Dayen, American Prospect, April 14, 2020 Article: Tax change in coronavirus package overwhelmingly benefits millionaires, congressional body finds By Jeff Stein, The Washington Post, April 14, 2020 Article: How Some Rich Americans Are Getting Stimulus ‘Checks’ Averaging $1.7 Million By Shahar Ziv, Forbes, April 14, 2020 Article: Stimulus Oversight Panel Has One Person Trying to Watch $2.2 Trillion Alone By Joshua Green, Bloomberg, April 14, 2020 Article: Coronavirus antibody testing must be covered free of charge, feds say By Stefan Becket, CBS News, April 13, 2020 Article: Unsanitized: Meet The Corporate Bailout’s First Policeman By David Dayen, American Prospect, April 13, 2020 Article: Who's getting these hundreds of billions in government aid? For now, the public may be in the dark By Peter Whoriskey and Heather Long, The Washington Post, April 13, 2020 Article: CARES Act Package Ushers in Changes to OTC Drug Review Process Duane Morris, April 13, 2020 Article: Commission calls for review of election security standards By Tom Temin, Federal News Network, April 13, 2020 Article: Medical Staffing Companies Owned by Rich Investors Cut Doctor Pay and Now Want Bailout Money By Isaac Arnsdorf, ProPublica, April 10, 2020 Article: Furor Erupts: Billions Going To Hospitals Based On Medicare Billings, Not COVID-19 By Jay Hancock and Phil Galewitz and Elizabeth Lucas, Kaiser Health News, April 10, 2020 Article: Providers Begin Receiving $30B in Emergency Funding from HHS, Plus Newly Suspended State Regs Home Care Association of New York State Blog, April 10, 2020 Article: The Colleges Getting The Most Money From The Stimulus Bill By Wesley Whistle, Forbes, April 10, 2020 Article: It is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform By Genevieve Razick and Carolina Wirth, Arnall Golden Gregory LLP, JDSUPRA, April 10, 2020 Article: Unsanitized: Federal Reserve Rescue Is the Best Rescue By David Dayen, The American Prospect, April 10, 2020 Article: The Fed’s ‘Main Street’ Mistake Wall Street Journal, April 9, 2020 Article: Exclusive: These for-profit colleges could reap up to $1 billion in federal bailout money By Matt Smith, Market Watch, April 9, 2020 Article: Fed's balance sheet swells to record $6.13 trillion By Jonnelle Marte and Ann Saphir, Reuters, April 9, 2020 Article: 'Extremely Alarming': Coronavirus Stimulus Law Allows the Federal Reserve to Hold Secret Meetings on Corporate Bailouts By Jake Johnson, Common Dreams, April 9, 2020 Article: Congress Must Have Skipped the First Three Seasons of Trump Reality Show By Eleanor Eagan, The American Prospect, April 9, 2020 Alert: U.S. CARES ACT ENABLES LONG-AWAITED OTC DRUG REGULATORY MODERNIZATION: KEY HIGHLIGHTS By Brian Burgess and Julie Tibbets, Goodwin, April 8, 2020 Article: Coronavirus: CMS approves nearly $34 billion in accelerated/advance payments to healthcare providers By Keith A. Reynolds, Medical Economics, April 8, 2020 Article: Trump removes inspector general who was to oversee $2 trillion stimulus spending By Ellen Nakashima, The Washington Post, April 7, 2020 Article: Welfare for Wall Street By Nomi Prins, The Nation, April 7, 2020 Article: Congress fixed tax code “retail glitch” and gave real estate a tax windfall By Rich Bockmann and Kevin Sun, The Real Deal, April 7, 2020 Article: Trump removes inspector general who was to oversee $trillion stimulus spending By Ellen Nakashima, The Washington Post, April 7, 2020 Article: Big Restaurant, Hotel Chains Won Exemption to Get Small Business Loans By Bob Davis and Heather Haddon, The Wall Street Journal, April 6, 2020 Article: CARES Act Contains Significant New Over-The-Counter (OTC) Drug Provisions by Charles Andres, Wilson Sonsini, April 6, 2020 Article: Trump’s Aggressive Advocacy of Malaria Drug for Treating Coronavirus Divides Medical Community By Peter Baker, Katie Rogers, David Enrich and Maggie Haberman, The New York Times, April 6, 2020 Article: Private Flights Getting Cheaper Thanks to Stimulus Tax Relief By Katherine Chiglinsky and Tom Metcalf, Bloomberg, April 6, 2020 Article: 2020 CARES Act—FAQs for Nonprofit Organizations and Donors By James P. Joseph Bridget M. Weiss Dana O. Campos, Arnold & Porter, April 6, 2020 Article: What does the CARES Act mean for net operating losses and non-corporate business losses? By Douglas Charnas and Paul Leonard, JDSUPRA, April 3, 2020 Article: Trump announces intent to nominate White House lawyer Brian Miller as inspector general for $2 trillion coronavirus law by Jeff Stein, The Washington Post, April 3, 2020 Letter: Addressed to Secretary of Department of Health and Human Services, Alex Azar By Alexander Sammon, American College of Emergency Physicians, April 3, 2020 Article: Unsanitized: Why Banks Don’t Want to Help Small Businesses By David Dayen, The American Prospect, April 3, 2020 Article: Unsanitized: Aid Package Status Update By David Dayen, The American Prospect, April 2, 2020 Article: It’s Steve Mnuchin’s Economy Now By Alexander Sammon, American Prospect, April 1, 2020 Article: US aims to lease space in emergency oil stockpile, after buying plan canceled, sources say Reuters, April 1, 2020 Article: Trump may rent Strategic Petroleum Reserve storage to U.S. drillers By ARI NATTER, JENNIFER A. DLOUHY AND STEPHEN CUNNINGHAM, World Oil, April 1, 2020 Article: Temporary Waiver of Required Minimum Distribution Rules By Jean McDevitt Bullens, Baker Newman Noyes, April 1, 2020 Article: Unsanitized: It’s the First of the Month By David Dayen, The American Prospect, April 1, 2020 Article: Citigroup CEO Michael Corbat says bank is 'working around the clock' on small business relief program By Hugh Son, The CNBC, April 1, 2020 Article: Tax Savings Opportunities from the CARES Act By John Werlhof, CLA, March 31, 2020 Article: The Relief Package Ushers In Trump's Planned Economy By Matt Stoller, Wired, March 31, 2020 Article: Federal COVID-19 Economic Relief and Its Impact on the Energy Sector: An Overview Energy Alert, Akin Gump Strauss Hauer & Feld LLP, March 31, 2020 Article: Boeing Will Take Aid, Won’t Give Equity Banking Exchange, March 31, 2020 Article: Bailing Out the Bailout By Matt Taibbi, RollingStone, March 31, 2020 Article: US Banks Welcome $2trn Stimulus Package By David White and Zachary Kribs, Kidney News Online, March 30, 2020 Article: CARES Act to Improve Options for People on Home Dialysis By David White and Zachary Kribs, Kidney News Online, March 30, 2020 Statement: FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation Commissioner of Food and Drugs - Food and Drug Administration - Stephen M. Hahn M.D., U.S. Food & Drug Administration, March 30, 2020 Article: Key Provisions in the CARES Act for Health Care Providers By Health Law Practice - von Briesen & Roper, s.c., The National Law Review, March 30, 2020 Article: CARES On Campus: Stimulus Program & Higher Education By Anne Cartwright and Julie Miceli, JDSUPRA, March 30, 2020 Article: Inside the CARES Act: Changes to the Bankruptcy Code Under the CARES Act By Melissa Anne Peña, The National Law Review, March 29, 2020 Article: Lawmakers Pack Federal Stimulus Bill With Pet Provisions By Brody Mullins and Ted Mann, The Wall Street Journal, March 28, 2020 Press Release: Trump Suggests He Can Gag Inspector General for Stimulus Bailout Program By Charlie Savage, The New York Times, March 27, 2020 Press Release: Statement by the President The White House, March 27, 2020 Article: Unsanitized: The Federal Reserve Loads the Cannon By David Dayen, The American Prospect, March 27, 2020 Article: Inside the talks on the largest U.S. bailout: frantic negotiations, partisan tensions and a Trump tweet By Seung Min Kim, Mike DeBonis, Erica Werner and Paul Kane, The Washington Post, March 27, 2020 Article: Over-the-Counter (OTC) Drug Monograph Process U.S. Food & Drug Administration, March 27, 2020 Article: The Health Care Industry and the CARES Act: Insight and Next Steps Akin Gump Strauss Hauer & Feld LLP, March 27, 2020 Article: Bank Regulatory Provisions in the CARES Act By Robert Klinger, Bryan Cave Leighton Paisner, JDSUPRA, March 27, 2020 Article: Fed Releases Details of BlackRock Deal for Virus Response By Matthew Goldstein, The New York Times, March 27, 2020 Article: Stimulus Bill Allows Federal Reserve to Conduct Meetings in Secret; Gives Fed $454 Billion Slush Fund for Wall Street Bailouts By Pam Martens and Russ Martens, CounterPunch, March 27, 2020 Document: Terms of Assignment for BlackRock on Behalf of the Federal Reserve Bank of New York Regarding Secondary Market Corporate Credit Facility New York Fed, March 27, 2020 Press Release: Acting Secretary Chad Wolf Statement on the REAL ID Enforcement Deadline Homeland Security, March 26, 2020 Article: How the Fed’s Magic Money Machine Will Turn $454 Billion Into $4 Trillion By Jeanna Smialek, The New York Times, March 26, 2020 Article: Unsanitized: The Essential Imbalance of the 2020 Bailout By David Dayen, American Prospect, March 26, 2020 Article: Bonanza for Rich Real Estate Investors, Tucked Into Stimulus Package By Jesse Drucker, The New York Times, March 26, 2020 Article: Funding to refill U.S. Strategic Petroleum Reserve cut from stimulus plan By STEPHEN CUNNINGHAM, ARI NATTER AND JENNIFER A. DLOUHY, World Oil, March 25, 2020 Article: Stop the $6 Trillion Coronavirus Corporate Coup! By Matt Stoller, BIG by Matt Stoller, March 25, 2020 Article: Unsanitized: Bailouts, A Tradition Unlike Any Other By David Dayen, American Prospect, March 25, 2020 Article: Fed taps BlackRock to run emergency programs By Dawn Lim, Market Watch, March 25, 2020 Article: Avoid Taxes, Receive Federal Bailouts By Alexander Sammon, American Prospect, March 25, 2020 Document: INVESTMENT MANAGEMENT AGREEMENT New York Fed, March 25, 2020 Article: Fine Print of Stimulus Bill Contains Special Deals for Industries By Eric Lipton and Kenneth P. Vogel, The New York Times, March 25, 2020 Article: Congress to bail out firms that avoided taxes, safety regulations and spent billions boosting their stock By Jonathan O'Connell, The Washington Post, March 25, 2020 Article: 'Completely Dangerous and Unacceptable,' Ocasio-Cortez Says of Impending Senate Recess in Midst of Coronavirus Crisis By Eoin Higgins, Common Dreams, March 25, 2020 Article: Senate leaving DC until April 20 after coronavirus stimulus vote By Jordain Carney, The Hill, March 25, 2020 Article: Senate stimulus bill extends funding for abstinence education By Tyler Olson, Fox News, March 25, 2020 Article: Oil purchase to fill strategic reserve dropped from stimulus By Benjamin J. Hulac, Roll Call, March 25, 2020 Article: U.S. Fed hires BlackRock to help execute mortgage-backed securities purchases By Pete Schroeder and Michelle Price, Reuters, March 24, 2020 Article: What is the Exchange Stabilization Fund? And how is it being used in the coronavirus (COVID-19) crisis? By Sage Belz and David Wessel, Brookings, March 24, 2020 Press Release: Federal Reserve announces extensive new measures to support the economy Board of Governors of the Federal Reserve System, March 23, 2020 Article: COVID-19 Update: Federal Reserve Launches TALF (Again) By Scott A. Cammarn and Mark Chorazak, The National Law Review, March 23, 2020 Article: Trump's coronavirus eviction freeze won't keep a roof over our heads, advocates say By Tim Fitzsimons, NBC News, March 21, 2020 Article: Addressed to Speaker Pelosi, Leader McConnell, Leader McCarthy, and Leader Schumer By Ben Lane, America's Health Insurance Plans, BlueCross BlueShield Association, March 19, 2020 Article: Fannie Mae, Freddie Mac, HUD suspending all foreclosures and evictions By Ben Lane, Housing Wire, March 18, 2020 Press Release: Federal Reserve Board announces establishment of a Commercial Paper Funding Facility (CPFF) to support the flow of credit to households and businesses Board of Governors of the Federal Reserve System, March 17, 2020 Article: Federal Reserve cuts rates to zero and launches massive $700 billion quantitative easing program By Steve Liesman, CNBC, March 15, 2020 Article: How the drug industry got its way on the coronavirus By Sarah Karlin-Smith, Politico, March 5, 2020 Article: How Much Of Boeing’s Revenues Comes From The U.S. Government? By Trefis Team, Great Speculations, Forbes, January 2, 2020 Article: Funding Legislation Delays $4B in Medicaid DSH Payment Cuts By Jacqueline LaPointe, Revcycle Intelligence, December 20, 2019 Article: Southwest Airlines reaches confidential settlement with Boeing for some of its 737 Max losses By Lori Aratani, The Washington Post, December 13, 2019 Article: Boeing 737 Max Factory Was Plagued With Problems, Whistle-Blower Says By David Gelles, The New York Times, December 9, 2019 Article: How Much Income Puts You in the Top 1%, 5%, 10%? By Julia Kagan, Investopedia, November 21, 2019 Article: Senator Seeks Last Win In Over-the-Counter Drug Bill (Corrected) By Alex Roff, Bloomberg Law, October 31, 2019 Article: Boeing’s 737 Woes Aren’t Hurting Its Pursuit of Military Contracts, Exec Says BY Marcus Weisgerber, Defense One, October 15, 2019 Article: What Percentage of Americans Owns Stock? By Lydia Saad, Gallup, September 13, 2019 Article: FDA Chief of Staff Calls OTC Monograph Reform a Top Priority By Michael Mezher, Regulatory Affairs Professionals Society, May 21, 2019 Article: These 30 companies, including Boeing, get the most money from the federal government By Samuel Stebbins and Michael B. Sauter, USA Today, March 29, 2019 Article: Boeing Was ‘Go, Go, Go’ to Beat Airbus With the 737 Max By David Gelles, Natalie Kitroeff, Jack Nicas and Rebecca R. Ruiz, The New York Times, March 23, 2019 Article: Agencies reporting proposal for the implementation of Current Expected Credit Losses (CECL) Deloitte, January 22, 2019 Article: FDA Opens the Door for a Broader Range of Over-the-Counter (OTC) Drugs by Charles Andres, Wilson Sonsini, August 2, 2018 Article: Jared Kushner Paid No Income Tax for years By Jesse Drucker and Emily Flitter, The New York Times, October 13, 2018 Guidance for Industry: Innovative Approaches for Nonprescription Drug Products U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 2018 Article: HISTORICALLY BLACK COLLEGES AND UNIVERSITIES: Action Needed to Improve Participation in Education's HBCU Capital Financing Program Office of Public Affairs, GAO, July 26, 2018 Article: 10 Things You Didn't Know About Alex Azar By Katelyn Newman, U.S. News, January 29, 2018 Article: The Richest 10% of Americans Now Own 84% of All Stocks Rob Wile, Money, December 19, 2017 Article: Why the newest sunscreens still haven't hit the U.S. market By Brady Dennis, The Washington Post, May 11, 2015 Article: Washington’s Skin Canc

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Cannabis Research - Why Marijuana Studies Do Not Get Done

Cannabis Legalization News

Play Episode Listen Later Apr 20, 2020 7:09

#cannabisResearch #marijuanastudiesWhy are so many myths about marijuana believed? Because it is almost impossible to study cannabis for its benefits. We discuss the federal roadblocks faced by possible researchers. First, anyone that wants to research cannabis must submit an investigational New Drug application to the FDA.Then the researcher needs to get cannabis to study, so they call the National Institute for Drug Abuse and ask for a letter of authorization to obtain the cannabis for study.Then, they must apply for a DEA registration and site licensure before conducting studies involving cannabis or any derivative. Then the researcher submits the application to the Center for Drug Evaluation and Research. The FDA claims to be committed to encouraging the development of cannabis related drug products – and resources researches to request a Pre-Investigational New Drug Application. https://www.cannabisindustrylawyer.com/cannabis-research-and-marijuana-studies/Support the show (https://www.youtube.com/cannabislegalizationnews)

research studies fda marijuana national institutes dea drug abuse new drugs cannabis research drug evaluation

Dead Doctors Dont Lie 14 Feb 2020

Dead Doctors Don't Lie Radio

Play Episode Listen Later Feb 13, 2020 54:00

Monologue Pharmacist Ben Fuchs fills in for Dr. Wallach discussing common chroni degenerative diseases. Contending these are all preventable through lifestyle changes and nutritional supplementation. Asserting that as people age the body begins to break down. But can be slowed by taking good care of the body through supplementation. Pearls of Wisdom Doug Winfrey and Ben Fuchs discuss a news article about sunscreens. A study published in JAMA reports that chemicals from sunscreens can be absorbed into the bloodstream. The director of the FDA's Center for Drug Evaluation and Research stated that even though the chemicals are absorbed it doesn't mean they unsafe. Ben states that when he had a compounding pharmacy and formulated sunscreens these chemicals came in bottles that had the skull and crossbones on the bottle. Callers Jane and two friends have been diagnosed with Raynauds Syndrome. Shawna has just been diagnosed with Parkinson's disease. Travis has type 1 diabetes, Celiac disease and psoarisis. Joseph has been diagnosed with retinitis pigmentosa. Call Dr. Wallach's live radio program weekdays from noon until 1pm pacific time at 831-685-1080 or toll free at 888-379-2552.

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The Scientific Approach to Address Uncommon Routes and Best Practices for Forming a Working Group

ToxChats©

Play Episode Listen Later Oct 3, 2019 18:29

In this episode, Dr. Armaghan Emami, a toxicologist with the Center for Drug Evaluation and Research at the US FDA and 2019 award winner of Best Paper Published in International Journal of Toxicology for her first-author publication, "Toxicology Evaluation of Drugs Administered via Uncommon Routes: Intranasal, Intraocular, Intrathecal/Intraspinal, and Intra-Articular" was interviewed. Dr. Emami discusses her inspiration for the collaborative paper, key considerations for the design and interpretation of studies utilizing an uncommon route, and provides advice to fellow scientists looking to form a working group or collaborative publication.

Giving Voice to Patients through Data

RARECast

Play Episode Listen Later Aug 7, 2019 36:18

Casimir Trials is a contract research organization that is seeking to bring patient and caregiver perspective into the clinical trials process. It’s working with drug developers to create endpoints and measures that can provide rigorous and quantifiable means of demonstrating whether an experimental therapy provides meaningful improvements to a patient’s quality of life. We spoke to Christine McSherry, co-founder and CEO of Casimir Trials, about the challenges of developing patient-centric outcome measures, how technology is allowing for the capture of real-world evidence, and how Casimir began with a challenge from the FDA’s Center for Drug Evaluation and Research Director Janet Woodcock to a mother and patient advocate concerned over the use of endpoints that could obscure the value of needed drugs to rare disease patients.

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Anne Pariser of NCATS Discusses the Future of Rare Disease Research

Vital Health Podcast

Play Episode Listen Later Jun 28, 2019 12:46

In this podcast we discuss the evolution of science that is driving the increasing focus on rare indications with Anne Pariser, the Director of the Office of Rare Diseases Research at the National Center for Advancing Translational Sciences (NCATS). Anne is a noted international expert or rare diseases, and has been involved in numerous collaborations within the FDA, as well as with drug developers, governmental agencies, patient groups and other stakeholders in the development of treatments for rare indications. Dr Pariser comes to NCATS from the FDA, where she had worked since 2000 on the development of drug and biological products for orphan and rare conditions. Dr Pariser also served as an associate director in the FDA’s Office of Translational Sciences, which is part of the Center for Drug Evaluation and Research (CDER).

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Director of the FDA’s Oncology Center of Excellence Discusses Expanded Access, Accelerated Drug Approvals

ASCO in Action Podcast

Play Episode Listen Later Jun 25, 2019 31:26

Subscribe to the podcast through iTunes and Google Play. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence. The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today. Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis. CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient? RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product. The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests. FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome. CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications? RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient. This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA. CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients? RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website. We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now includes the expanded access programs listed in ClinicalTrials.gov. Patients and physicians can look for treatment options. They could discuss clinical trials, and company information could be provided at the navigator at Navigator.Reagan-Udall.org. So this is really to give patients and their physicians information about what is out there. Once the patient obviously has this information and their doctor, then the doctor can utilize the Project Facilitate, which allows easier access to actually submitting these forms and going through the actual process. I'd like to emphasize that companies are now required by the 21st Century Cures Act to publicly list their expanded access policy. And the Reagan-Udall Navigator website helps them comply with that requirement. Again, so once the physician and the patient have identified the investigational therapy they want to try, the physician or other members of the health care team then can contact Project Facillitate for assistance in locating IRB resources and help with the FDA form 3926. CH: So I think you mentioned this when you launched this or announced it at the annual meeting just now, that physicians do already-- or at least before project facilitate often would successfully go straight to pharmaceutical companies and ask for treatments. And I guess in some cases they'd be denied, and in some cases they would be approved. And that would be through the company's expanded access programs. Obviously, that means that regulators wouldn't necessarily know the full extent of expanded access use. So assuming that Project Facilitate will allow the FDA to collect much more data on expanded use, how will the data be useful? And obviously, I'm hinting at the fact that some fear that it will be actually a negative. RP: Well, prior to launching Project Facilitate, the expanded access requests for cancer patients arrived at multiple places within the FDA and were forwarded separately to FDA oncology or hematology divisions. Sometimes these requests could be delayed, being sent from one place to another in the agency. So this gives a focus point for physicians to contact. In addition, we're seeing that most of the expanded access requests were coming from patients and physicians at larger academic centers. The patients who don't live near these cancer centers and may not be able to get on clinical trials can also hopefully have access to investigational agents by having a more facile and easier process to use here. We're also seeing that many companies have turned down requests from patients, and we have no idea what really the number of requests a company may get if they're turning down these requests. Because generally, they don't come to the FDA. So really, by having the initial contact at the FDA we'll be able to determine number one, the number of patients that are requesting a single patient access. We'll also be able to determine and discuss with the companies their reasons for denying these requests. And there could be multiple reasons. And we also have a process in place that can follow up with what are the benefits that an individual patient may have from this therapy or, as I stated before, were there any adverse events. We have also heard this kind of urban myth-- and I label that in quotations, "urban myth," that companies fear that perhaps adverse events may be held against them when their drug is coming for drug approval. We have not done that. We take into context where the adverse event reporting is coming from. And there really are no instances that I am aware of in oncology where a report of an adverse event has delayed or curtailed an approval of a drug. CH: So really, this is a bright ray of sunshine on a dark corner of drug access. And if it works right, you'll just have much more understanding of the overall use of expanded access. Right? RP: Yeah. I think that gives some clarity to the process here. Here again, we don't know the numbers at this time of actually the number of patients. We only know the numbers of patients that receive a affirmative position from the drug company regarding that the process can continue. But we don't know the numbers of patients that may be requesting single patient access and are denied by an individual drug company. And also, the reasons. And, as I stated before, there can be very legitimate reasons, including inadequate supply of the drug, lack of support staff to follow up on these drug requests, potential interference with clinical trials that the patient may be eligible for. CH: You just used a phrase about patients requesting. And I thought as you described this process you were referring to physicians requesting on behalf of patients. And so I do want to ask, are there resources that are aimed directly at patients or is it really solely aimed at the oncologists in this case? RP: Well, here again, this is a two-prong process. Project Facilitate, the FDA portion of this, is for physicians to call up for assistance in filling out the form and also navigating the process once the decision is made. The other prong of this is, as I stated before, by Reagan-Udall foundation, which patients can call to look at what our options available to them that are potentially listed on ClinicalTrials.gov. And that is also for patients and physicians. However, the portion of the program that is Project Facilitate is for the requesting physician. CH: All right. Well, that's clear. So once we talk about patient's involvement, and even many physicians I think for that matter, we quickly can drift towards the very heated discussion that took place in public over the last year in the area or that we call Right to Try. And I wonder if you could talk for a minute and help us, for the listeners, make this distinction between expanded access and Right to Try. RP: Of course. These programs, Right to Try and single patient INDs are really mutually exclusive programs. The main difference between these programs are first, that under Right to Try the drugs have to complete a Phase I trial. For single patient INDs, it could be done anywhere, even within the context that the drug is being conducted in a Phase I trial. However, the major difference is that the FDA and the IRB does not review Right to Try applications, whereas under a single patient IND, the FDA obviously has to give permission for the patient to proceed as well as an IRB has to review these requests. CH: So to be very clear, Project Facilitate is supporting the single patient INDs, and Right to Try is a separate matter entirely. They are distinctly different programs. Project Facilitate does not apply to Right to Try. That is an independent, separate program. CH: Great. So, you know, one of the problems for a busy clinician is figuring out how to do all this under pressure with a sick patient, and the other pressures of clinic and administration and research. If our listeners want to learn about this more casually, where can they go not under duress, just to start reading up and learning about how to access the program? RP: They could go-- physicians can go and learn more about the program at our website, www.FDA.gov/oce. The Project Facilitate phone number is 240-402-0004. That's 240-402-0004. And the email address is ONCProjectFacilitate@FDA.HHS.gov. CH: That's great. So hopefully, some of our listeners will take advantage of that and learn about this when they're not under pressure so that they're familiar with it if they have to turn to it some months later. Now you mentioned that the host is the Oncology Center of Excellence. And I mentioned in my introduction that we would want to talk a little bit about that. CH: You've been at the helm of the OCE since it was established a little over two years ago, I think. Now that you've been in the role a while, I wonder if you could talk a little bit about your view of what the OCE should be accomplishing, and maybe how that aim has evolved over these two years. RP: Yes. The OCE basically was an offshoot of the Moonshot Program several years ago, and was aimed to be the first center that coordinates activity among the therapeutic center. Obviously, at the FDA there is a center for drugs, a center for biologics, and a center for radiologic health and devices. And they all can review oncology products. The OCE has a designation to really coordinate the activities, particularly in the clinical review of the products that involve the treatment of cancer. So, this is a unique center within the FDA, and is somewhat of an experiment at the FDA to see how we can really coordinate the activities of drugs that affect cancer patients. And here again, the oncology center is primarily designated for the clinical review. And we don't really get into the manufacturing of drugs. That's handled in the individual centers, whether it be a biologic and CBER, the Center for Biological Evaluation and Research or CDER, the Center for Drug Evaluation and Research. With that given said, in addition to the actual bread and butter of reviewing applications, we have many research projects that we're doing. We have a big project looking at real world data. We have a project looking at updating labels called Project Renewal. We have, as I stated before, this project that we launched at this year's ASCO, Project Facilitate. We also have a project aimed at really improving our relationships with international drug regulators. We have monthly meetings, teleconferences with five different regulatory agencies throughout the world to go over applications and discuss different regulatory policies. We have a host of a symposium that we conduct both here at the FDA, inviting external stakeholders including physicians, leading academics, patients to come to the FDA really to discuss important topics to our drug reviewers and the entire discipline of regulatory and oncology, so to speak, how we make decisions in medicine. We have a whole, also, program that we're developing aimed at educating physicians and other health care professionals for educating other health care professionals on how we evaluate drugs, what our thought processes are here at the FDA. So, in addition to the regulatory work, there is a whole body of scientific work that we're also doing, including independent research on different databases, looking at patient populations more likely to respond to different drugs, ways of evaluating and describing toxicities, ways of really looking at patient experiences while they're getting drugs, and different ways of reporting patient reported outcomes. We'd like to thank ASCO, obviously, for their assistance during and helping us with many of these projects throughout the year, especially the educational projects involving fellows, involving different topics that we've found of interest that needed to really have a public disclosure in the community, really, to get input from leading academics, as well as treating physicians. CH: Wow. You are busy. And there's a lot we could unpack there. But I do want to pick up on a couple of things. First of all, you described this as an experiment, so I'm curious. And not to put you on the spot, but if you have an experiment, I presume that just some metric that you would use to call it a success or failure. And I wonder where you think you are right now in that regard. It sounds like you've gotten a tremendous amount done. But are you satisfied, for example? Have you covered the ground you wanted to or do you think that you could be doing more? RP: Well, people who know me realize that I'm never satisfied. So, I think we're in the middle of this experiment. I think it's going quite well. And I think that this is really going to be aimed at-- and the evaluation of the success or failure of this is going to be really how the individuals that work here at the FDA really evaluate drugs and how we facilitate the evaluation of drugs. And also the really important of retention of staff here at the FDA is a major issue, also. And I think many of the projects that we have ongoing really develop our reviewers in really having a real world approach to how oncology drugs are used. So it's very difficult to say what success and failure will ultimately be. But I think we're on, really, the correct path, and pretty much a straight path of looking at a successful venture here. CH: You know, one of the things you said reminded me of another urban myth. And I don't know if you realize this. But when you describe the careful coordination with, I think you said five regulatory agencies around the world, it raises the myth, I believe, but you can address this with some facts, that many people in the United States believe that others around the world have faster access to a broader range of effective therapies. I wonder if you want to expand on that or comment on that at all before we move on. RP: Well, that is an urban myth, and probably was generated 20, 30, 40 years ago when that may have been the fact. Obviously, that antedated my coming to the FDA. But I can say the vast majority of drugs are approved first in the United States. And those include very important drugs such as the PD1 drugs, the targeted drugs, et cetera. They are approved first in the United States. We have taken a very active approach to really rapid approvals of our drugs without sacrificing quality, by having a smarter approach to how we review these drugs, with putting multiple reviewers on particular applications, by cutting down on unnecessary paperwork that many of our reviewers had to do, and really focusing on really the core material that we have at hand, and really emphasizing does this drug really demonstrate safety and efficacy. At the end of the day, I charge all of our reviewers with the following statement. Would the American public be better with this drug than without it? And that's the ultimate decision that we have to make at the time of approval. CH: Well, that's another perfect segue to a hot topic, which you and I have discussed actually offline before this. But I'm going to come back to it. The expedited approval of anticancer therapies was recently the subject of a paper in The Journal of the American Medical Association. And if I remember correctly, they looked at 93 cancer drugs that had been approved through accelerated approval process. But what they claimed is that only 19 of the 93 clearly extended the lives of the patients taking them. That's a value judgment, obviously, about why drugs are approved and introduced to the market. But I wonder if you would want to talk a little bit about your view of some of the complexities and challenges that are inherent in accelerated drug approval, and what your view is of this particular study of the approval outcomes. RP: I think many times people don't understand that it isn't just about overall survival. Obviously, that's the gold standard. But we've had very careful discussions throughout the years that there are many ways to evaluate benefit to the patient. And that includes reduction of the size of the tumor, delay in the progression of the disease, the establishment of complete response rates in hematological diseases. So we have to have some flexibility, both in terms of how we approve drugs and what clinical trials we're going to ask for after drugs have been approved on the accelerated approval pathway. Although overall survival is a very important end point, it's an important efficacy endpoint as well as a safety endpoint, it does have limitations. As we move more toward a targeted therapy and subsegment common diseases into molecular subtypes, many times we find that we have very limited populations. And simply, we don't have the size of a population that we approve the drug on to really do a large, randomized trial. So we have to weigh that issue with what type of trial we're going to ask for, both with the initial approval of the drug as well as with, perhaps, the subsequent studies that we ask for after an accelerated approval. In addition to that, many times we find that we have situations where the disease itself may have a very long natural history, such as CLL or other diseases that may have very long natural histories, where one cannot really do a long-term survival study because it would extend many, many, many years. And many times-- and I think we have to be realistic about this, that there may not be equipoise here to allow a randomized trial to be done looking at overall survival as a primary end point. For example, if we already have information that a drug may have a response rate of 50% or 60% and the comparator drug may have a response rate of 10%, patients will not want to go on a study that looks at overall survival as the primary end point. And many times, we have to take a look at time to progression or progression free survival and those end points, and actually allow for a switch in therapies or crossover at the time of disease progression, which renders the evaluation of overall survival somewhat difficult, and may confound that evaluation. So, there are many reasons why overall survival, although a gold standard, may not be applicable to all situations. And I think that's going to be increasingly so as we get into a more targeted therapy approach and have better definitions of who is going to respond. So here again, it's long natural history of diseases either by its natural history or by the therapies that have been approved that prolong disease. It could be due to the limited populations, which preclude a randomized trial. And it could be due to the lack of equipoise, which really bands that patients have access during the course of disease. I think a much more important question, and one that we are constantly looking at, is not so much what does an individual drug do to the natural history of the disease and prolonging survival in patients that have metastatic disease, but what is the impact over the years of multiple drugs being approved on the basis of progression-free survival or response rates when they are used either in combination or sequentially. And we could see that, for example, in multiple myeloma, where the course of that disease has been significantly changed, and patients' lives have been prolonged. And the vast majority of the drugs that have been approved have been on non-survival endpoints. And this is true not only for multiple myeloma, but also probably for renal cell cancer. CH: Yeah. That's interesting. It's a challenging analysis, of course. But that would be a very interesting, essentially public health roll up of all of these incremental decisions. Right? RP: Correct. CH: Yeah. So, as I said before, the OCE has been in operation just over two years. During that time, more than 80 therapies and products have been approved, I think. Right? And there've been more than a dozen guidance documents approved, 60 workshops and symposia for oncologists and for patients. And there were several of those workshops that we at ASCO were privileged to co-sponsor along with you. This is the favorite child question. But what's your proudest achievement so far? RP: A difficult question, but an easy question, too. It's about the people that work here and the patients that we serve. And I think my brightest moments are when we see the development of our people coming in and taking leadership positions both within the agency in a regulatory context of their job, but also in the academic fields and participating in conferences, publishing papers, and really finding enjoyment in the job that they have outside of the day-to-day regulatory activity. One of the things that I have always emphasized since I came here 20 years ago from an academic medicine position at M.D. Anderson is really to give the agency a much more academic perspective. And I've always stated that I think we do much more academic work here at the FDA than many academic centers. And I'm not talking about the generation simply of papers or research grants. I'm talking about actually critical thinking of what goes on at an application, since we have a multi-disciplinary team of statisticians, clinicians, clinical pharmacologists, toxicologists, manufacturing people that all work together. So it's really about-- my greatest accomplishment is really about the young people that have come in that I've mentored, and really have assumed roles, and really will be my lasting legacy here. But I also want to emphasize that one of the things that I have repeatedly highlighted to this staff is really to consider the patient in really any regulatory decision. Here again, it's not about a P value. It's not about a primary end point. Granted, those things are important, but we really have to bring together the whole body of information about a drug in making a regulatory decision and making that a patient-focused thing. And as I stated before, at the end of the day will the American patient-- will the American public be better off with this drug than without it? CH: Well, Rick, I got to say that's an inspiring description. It makes me wish I were younger, and maybe I could come and be mentored. But alas, it may be too late for me. But we really are proud to work with you, and to work with so many of your staff in many productive collaborations. I want to thank you again for joining me today for this ASCO in Action podcast. We always appreciate your expertise and your perspectives. And we look forward to continuing to work with you to ensure that patients with cancer have access to safe and effective treatments. RP: And thank you, Cliff. It's been a pleasure. And here again, I really think ASCO for providing a lot of resources to us in conducting symposium, and really in fostering better cancer care for patients. I think that's the ultimate goal of both organizations. CH: It sure is. And I want to remind our listeners that you can follow the FDA Oncology Center of Excellence on Twitter. Their handle is @FDAOncology. That's one word. You can follow me @CliffordHudis, and you can follow ASCO @ASCO. For more information on the latest cancer policy news and updates, visit ASCOAction.ASCO.org. And Rick, I'm going to ask you once more to remind the listeners of the way they can access Project Facilitate. RP: They can learn about Project Facilitate from our website at www.FDA.gov/OCE. And our project facilitate phone number is 240-402-0004. And the email address is ONCProjectFacili tate@FDA.HHS.gov. ONCProjectFacilitate is spelled O N C P R O J E C T F A C I L I T A T E @FDA.HHS.gov. CH: That's great. So until next time, I want to thank everyone for listening to this ASCO in Action podcast.

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In Vitro and Alternative Models for Regulatory Submission

ToxChats©

Play Episode Listen Later Nov 30, 2018 46:53

In this two-chapter episode, in vitro and alternative models for regulatory submissions were explored from both an industry and government perspective. In the first chapter, Dr. Clive Roper, the head of In Vitro Sciences at Charles River Laboratories, and Dr. Lauren Black, a senior scientific advisor at Charles River Laboratories discuss the current landscape of in vitro and alternative models and share their thoughts about future directions of the field. In the second chapter, Dr. Paul Brown, the associate director of pharmacology and toxicology in the Office of New Drugs in the Center for Drug Evaluation and Research at the US Food and Drug Administration, discusses the acceptance of in vitro models for safety evaluations and the value of integrative toxicology.Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not necessarily reflect the official policy or position of the American College of Toxicology. For the College’s policy on the ethical treatment of animals in research, please see our comprehensive policy statement at www.actox.org.

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Regulation of E-Cigarettes

ToxChats©

Play Episode Listen Later Jul 19, 2018 21:24

In this episode, Dr. Arianne Motter, a toxicologist with the Center for Drug Evaluation and Research at the US Food and Drug Administration, discusses the complex regulation of e-cigarettes at the FDA and the issues that toxicologists face when evaluating the potential these products have to reduce harm and the risk of tobacco-related disease. At the time of recording, Dr. Motter was a toxicologist with the Center for Tobacco Products at the FDA.

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The FDA's Adverse Event Reporting System (FAERS) Public Dashboard

FDA Drug Information Updates

Play Episode Listen Later Oct 28, 2017

Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of Surveillance and Epidemiology created and released a tool that makes FAERS data easier to query and retrieve. This new interactive dashboard is designed to expand access of FAERS data to the general public. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, discusses the advantages of the tool as well as its limitations.

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The Promise of Biosimilars

Frankly Speaking About Cancer with the Cancer Support Community

Play Episode Listen Later Aug 29, 2017 56:55

In 2010, the Biologics Price Competition and Innovation Act signed into law by President Barack Obama as part of the Affordable Care Act, aimed to promote the development of biological products and create competition, with the goals of increasing treatment options and reducing health care costs. On this episode, we are joined by Dr. Leah Christl who is the Associate Director for Therapeutic Biologics in the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. Today, we are starting to see the fruits of that labor, there are several biosimilars on the market and more are under review for approval. In 2015, the U.S. Food and Drug Administration approved the first biosimilar product which happens to be a supportive treatment for cancer patients undergoing chemotherapy for acute myeloid leukemia.

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Real World Evidence with Office of Medical Policy Director Jacqueline Corrigan-Curay

office medical fda bio policy director corrigan rwe real world evidence drug evaluation

Play Episode Listen Later Jun 23, 2017 14:32

We talked to Center for Drug Evaluation & Research Office of Medical Policy Director Jacqueline Corrigan-Curay at BIO about FDA’s current work on real world evidence. Corrigan-Curay explained how FDA doesn’t see a contradiction between randomization and RWE and ways to gradually start incorporating real world data in the drug development.

A Conversation with FDA's Janet Woodcock