Episode Details

In this episode of Hims House, Jonathan Stern and Patrick Lester (“Bayside”) sit down with Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) and former FDA Associate Commissioner. Pitts recently authored a paper arguing that the FDA has failed to enforce existing limits on GLP-1 compounding, creating major public-health risks. They explore how CMPI operates and who funds it (big pharma), whether compounders are breaking the law or simply skirting its intent, and why the FDA’s resource constraints may explain its lack of action. The discussion digs into the dangers of unregulated foreign API supply chains, Pitts’ critique of “phony personalization” schemes, and how aggressive advertising complicates oversight. They also look at the enforcement tools available—from the 5% rule to “too difficult to compound” lists—and debate whether we’ll see targeted crackdowns or blanket bans.

00:00 – Intro

01:14 – Background on Pitts & CMPI

03:08 – Initial Views on Hims

05:43 – Are Compounders Breaking the Law or Just the Spirit of the Law?

10:58 – FDA Enforcement Gaps & Compounding Loopholes

18:33 – Unregulated Foreign API and Supply Chain Risks

23:53 – “Phony Personalization Schemes”

25:05 – Should Dosing Be Individualized?

25:30 – FDA’s Role in Dosing Oversight

26:11 – Why Pitts Thinks "Personalization" Claims Fall Short

32:11 – Where GLP-1 Regulation May Be Headed

35:11 – Odds that the FDA and/or Congress Will Crack Down