The FDA: A Spoonful of Safety Makes The Medicine Go Down
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 Food and Drug Administration. 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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Resources
Why Are So Many Useless Cold Medicines Littering Pharmacy Shelves?
Oral phenylephrine: An ineffective replacement for pseudoephedrine?
FDA Briefing Document: Efficacy of Oral Phenylephrine as a Nasal Decongestant (PDF)
Federal Register/Vol. 81, No. 195/Friday, October 7, 2016/Rules and Regulations (PDF)
