In this special edition premiere of Post Scrip, host Henry sits down with Dr. Jerry Avorn, MD, Harvard Medical School professor and author of the groundbreaking book Rethinking Medications: Truth, Power and the Drugs You Take. Dr. Avorn, a senior internist at Mass General Brigham and author of over 600 papers, takes us on a dive into the complex world of drug approval, pricing, and pharmaceutical policy.

This episode explores how the FDA's accelerated approval pathway, originally designed for AIDS drugs, has been used in part for medications like Aduhelm, the Alzheimer's drug that didn't work, could cause brain damage, and all at a high price. The conversation delves into the erosion of randomized controlled trials, the problematic influence of user fees on FDA decision-making, and Dr. Avorn's experience as an expert witness in the landmark Vioxx litigation.

Dr. Avorn discusses the challenge of "doing your own research" when drug companies control access to study data, his work in academic detailing to compete with pharmaceutical marketing, and the "because I can" pricing strategy that drives up drug costs. He also shares insights about maintaining independence by refusing personal consulting fees from pharmaceutical companies and about his organizations that focus on unbiased drug evaluation and education.

This conversation will hopefully encourage discussion among pharmacists, attorneys, healthcare professionals, and anyone seeking to understand the forces shaping modern medicine, drug policy, and drug pricing.

In this episode of Post-Scrip, Henry introduces Jenni Wai, RPh. , MBA, Josh Bolin and Christopher R. Smith, JD, LLM. They discuss the upcoming "Regulatory, Industry and Legal Perspectives on the Future of the DSCSA".

This presentation will provide an update on the final stages of implementation of the DSCSA and anticipated future regulatory efforts. We will begin with a brief high level overview of the DSCSA, including a summary of recent regulatory developments, such as any new regulations or guidance documents issued by the FDA in 2024 with regard to the DSCSA. We will then pivot to address the end of the one-year FDA stabilization period, recent feedback from the pharmacy industry regarding DSCSA compliance concerns, and the readiness of the pharmacy industry to fully implement and obstacles to implementation of the interoperable electronic exchange of transaction data.

We plan to include a discussion of the tools available to pharmacies to assist with compliance with DSCSA requirements as DSCSA implementation evolves. We will further discuss the challenges that state regulators face with regard to ensuring that dispensers, wholesalers and manufacturers comply with the DSCSA, particularly with regard to ensuring that stakeholders have robust processes for identifying, investigating and responding to suspect and illegitimate products.

Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona

In this episode of Post-Scrip, Henry introduces Marty Allain, JD. They discuss the upcoming "How Drug Manufacturer Restrictions and Recent Court Decisions are Re-Shaping 340B Drug Distribution and Delivery Models".

Pharmaceutical manufacturers continue to restrict the delivery of 340B drug discounts to contract pharmacies in response to the growth of 340B sales, perceived non-compliance with 340B program requirements, and statutory interpretation. These restrictions have a significant financial impact on hospitals, health centers, and other health care providers that participate as “covered entities” in the 340B program.

This presentation will also cover other “hot topics” with respect to 340B contract pharmacy arrangements, including the impact of the U.S. District Court Decision, Genesis vs. Becerra, rejecting a restrictive interpretation of “patient” under the 340B program.

Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona