APC files citizen's petition on DTE

Even with all the work at the state level, fear not — APC is still actively engaged in issues in Washington. This week we submitted a citizen petition to FDA asking the agency to reverse its decision classifying desiccated thyroid extract as a biological.

But that’s not all. In the same petition we ask it to clarify that its August 6, 2025 “Notice to Industry” does not constitute an across-the-board ban on compounding animal-derived thyroid preparations for individual patients. In fact, we’d like FDA to be unambiguous when it comes to natural thyroid products: They should be evaluated and approved as drugs, not biologics. (In the future we’d like to see the agency engage stakeholders to developing a science-based framework for thyroid compounding that ensures quality while preserving patient access.)

So what happens next? Technically, FDA has 180 days to respond to a citizen petition, but we’ve heard sometimes that takes longer. We’ll keep you updated, of course.