Episode Details
Back to Episodes"REFILL" | Peter Pitt on FDA Advisory Committees, Make America Healthy Again, and Drug Pricing (Originally Aired: May 23, 2025)
Description
Joe Grogan sits down with Peter Pitt, FDA veteran and expert on healthcare regulation, to discuss FDA advisory committees, the Make America Healthy Again initiative, and critical gaps in pharmaceutical labeling. Pitt addresses why obesity-related drug dosing information is missing from labels, the importance of vaccine safety, food regulation reform, and strategies for lowering drug prices through generic drug reviews and supply chain diversification. He also discusses the need for FDA and CMS to work together and warns against mission creep at CMS.
Key Timestamps
0:44 Background: East Coast native, McGill University, from New York City
1:07 How he got a professorship at University of Paris School of Medicine
2:35 Mark McClellan connection and FDA career start
5:19 Conflicts of interest versus interests in FDA advisory committees
7:07 Why people need to be dismissed from advisory committees
9:13 Three basic reasons FDA holds advisory committee meetings
11:08 Why Canada keeps advisory committees secret versus FDA transparency
14:08 Advisory committees for CYA, new science, and lack of consensus
19:44 Op-ed on vaccines and nutrition under Make America Healthy Again
22:44 Cancer drug dosing for obese patients and missing label information
27:15 Learning about drug dosing outside of clinical trials
30:42 Food regulation and FDA's second-class treatment of food safety
32:02 MAHA moment and removing red food dyes from food supply
34:00 Dietary supplements regulation under DSHEA
35:21 Nutrition labeling updates and soda bottle serving sizes
38:21 PDUFA reauthorization and user fees
40:32 User fees about predictability not speed
42:54 CMS mission creep and encroaching on FDA authority
Key Topics
FDA advisory committees, transparency, vaccine safety, Make America Healthy Again, pharmaceutical labeling, obesity and drug dosing, food regulation, dietary supplements, generic drug review, PDUFA reauthorization, user fees, CMS mission creep, drug pricing
About the Guest (at time of recording, May 2025)
Peter Pitt is President and Co-Founder of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine. He is a former associate commissioner at the FDA where he oversaw advisory committees and served as a senior policy and communications advisor. Pitt is a native of New York City, a McGill University graduate, and speaks fluent French.
Podcast: DC EKG with Joe Grogan
Host: Joe Grogan
Guest: Peter Pitt
Sponsor: Survivors for Solutions
Executive Producer: John CZ Czwartacki, DC EKG Podcast