APC responds to FDA’s GLP-1 statement

The big news in the compounding world this week was, obviously, the statement by FDA commish Martin Makary that the agency is looking at restricting GLP-1 APIs for compounded drugs.

To be honest, we’re a little confused. What authority would FDA use to restrict the API? The Food, Drug, and Cosmetic Act is clear that if the API is part of an FDA-approved drug, it can be used in compounding when a prescriber finds that necessary. Arbitrarily restricting one or two APIs would not only go against the law and precedent, it would open one heck of a legal can of worms.

“Sure, they could move forward with Novo’s and Lilly’s request that semaglutide and tirzepatide be added to the Demonstrably Difficult to Compound list,” said APC CEO Scott Brunner. “But the scientific case for that is flimsy at best, plus it would require a protracted notice-and-comment rulemaking process, so it wouldn’t happen fast, and I suspect it would also be slowed down by litigation. Beyond that, the agency has already validated GLP-1 manufacturers via the Green List, so it’s a puzzle as to what Dr. Makary has in mind.”

Brunner expressed APC’s concerns in a letter to the commissioner, sent Monday, and raised some additional issues with his statement — including what appears to be his lumping legitimate, state-licensed pharmacy practice with unlawful gray-market activity. That’s a favorite tactic of drug companies, but the FDA and Dr. Makary should know better.

To complicate the issue, the same FDA statement said the agency was “taking steps to combat misleading direct-to-consumer advertising and marketing” around compounded drugs. Specifically…

[C]ompanies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.

We like to think that the first part has little effect on legitimate compounding pharmacies; they already know the rules about marketing (and APC has a best practices document if they need a refresher). It’s the second part that had us do a double-take. Of course compounded drugs use the same active ingredient as their FDA-approved counterparts — they have to; that’s the law. Saying the APIs are identical is a matter of fact, and certainly not false or misleading.

If you’d like to read more about the whole issue, the National Law Review has an excellent article covering the FDA’s statement, what it means, and what’s at stake.

But wait, there’s more

Sauce for the gander: The FDA has told Novo Nordisk that the company’s ad for its Wegovy pill, which debuted during the Super Bowl, was “false or misleading” and the company has to stop using it.

And the final* twist? Novo Nordisk has filed a patent lawsuit over the telehealth platform’s compounding with the semaglutide API. It’s the first such GLP-1 patent lawsuit, and obviously APC will be keeping an eye on it … and the broader issue. We’ll keep you in the loop.

* Well, final for the moment, but probably not the final final twist.