STATEMENT OF ALLIANCE FOR PHARMACY COMPOUNDING CEO SCOTT BRUNNER, CAE, ON FDA’S ANNOUNCED INTENTION TO "take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs)”

I guess my initial question is: What authority does FDA have to restrict compounding with a particular API that otherwise meets Congress’ plain language in the Food, Drug & Cosmetic Act about what can be compounded? The agency notice seems to suggest they're not looking to restrict compounding of GLP-1s; they are looking to restrict the API itself. I suppose they could move to do what the drugmakers have long demanded and add the API to the (not-yet-existent) Demonstrably Difficult to Compound List, but that would require notice-and-comment rulemaking. Are they telegraphing an intention to do rule-making? Good to know.

That said, based on what I've read about the Hims oral semaglutide formulation announced yesterday, it appears to adhere to the stipulations of FDA's “Essentially a Copy” guidance document. If that's so, I'm perplexed at what they seem to believe is violative conduct.

I find it curious, too, that part of FDA’s focus in its statement today is on misleading marketing claims. I didn't see anything violative in Hims’s announcement. Hims did say it's the same API as Wegovy. But it has to be, right? Otherwise, it would not meet the FD&C Act requirements about what substances can be compounded. We've gone through four years of compounded GLP-1 frenzy and not once has FDA asserted that the semaglutide (or tirzepatide) API the drugmakers are using is somehow superior or even different from that used by compounding pharmacies. So I’m baffled if FDA’s beef is about claims made in yesterday’s announcement.

APC will continue to watch this issue, and we’d certainly be willing to advise FDA if invited.