We’ve told you about FDA’s double-whammy statement a couple of weeks ago — the one saying that 1) the agency will (may?) be cracking down on the use of GLP-1 APIs, as well as 2) suggesting enhances enforcement on what it sees as inappropriate marketing of compounded drugs.
We were confused about those statements for a number of reasons, and it turns out we’re not alone. Attorneys who follow pharmacy regulation were just as unclear about what the agency will actually do, and what legal precedent it might lean on, considering that both statements — the potential API limitations and the crackdown on advertising — seem to run counter to the Food, Drug, and Cosmetic Act.
Writing for FDA law blog this week, Karla Palmer and Sara Koblitz’s of Hyman Phelps expressed their confusion about the logic and legality of the agency’s arguments for potentially limiting an API, while also wondering what legal ground the FDA is standing on as it prohibits compounders from stating (truthfully) that their compounded formulations use the same active ingredient as FDA-approved drugs. But beyond the (lack of) logic, they consider the bigger picture revealed by the statements:
While FDA seems to be tightening its regulatory scrutiny of GLP-1 compounders now, the agency could refocus on compounders of other compounded formulations, particularly when a new drug receives approval, and is not in shortage. (emphasis in original)
Meanwhile in a blog post for Skadden, Rachel Turow questions the legality and indeed the advisability of what seems to be the agency’s new enforcement approach. It could, ironically, end up confusing patients — a ‘problem’ the agency says its trying to solve.
Turow puts the legal issue succinctly: “FDA’s position, as currently articulated, appears to be inconsistent with the federal Food, Drug, and Cosmetic Act, FDA’s prior communications about active pharmaceutical ingredients used in compounding, and longstanding agency practice.”
Both pieces hone in on the same point: It seems FDA is telling pharmacists that they can’t say something that — per the law and FDA policy — is factual. That strikes us as something that’s going to end up in court soon enough.