The FDA: A Spoonful of Safety Makes The Medicine Go Down

Oct 25, 2023

This podcast explores the FDA's regulation of drug safety, including the recent removal of the nasal decongestant phenylephrine. It discusses the historical focus on drug safety, the devastating effects of Thalidomide, and the FDA's priorities in drug approvals. The podcast also addresses public mistrust in the FDA and the challenges they face in ensuring testing rigor and transparency.

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Introduction

00:00 • 2min

FDA's Focus on Drug Safety and Efficacy

02:22 • 16min

Phenylephrine: A Questioned Nasal Decongestant

17:59 • 7min

FDA Priorities and Drug Approvals

24:34 • 19min

Addressing Public Mistrust in the FDA and Ensuring Rigor in Testing and Transparency

43:53 • 3min

Culture and Challenges at the FDA: Nuance, Education, and Trust

46:27 • 5min

On this week's episode of the pod, we are talking about a drug that's been available for decades but is suddenly being pulled from shelves: phenylephrine (something you've probably reached for when you've been congested). We bring on an expert, Dr. Mikkael Sekeres, a Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami who formerly chaired the Oncologic Drugs Advisory Committee of the FDA. Dr. Sekeres helps us walk through the history of the FDA's regulation of the safety and effectiveness of drugs. We discuss some other notable examples throughout history that demonstrate the evolution of the regulatory agency. We know this is a very hot topic and we hope you'll tune in to better understand how the FDA operates. You definitely don't want to miss this!

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