APC talks, FDA listens

On April 11, the FDA held a “listening session” with APC, where the agency sat down to hear our perspective — and concerns — on a range of compounding issues. It lived up to its name; “listening” is all the agency did in the meeting, although they did ask some questions. Importantly, we felt heard.  

The topics we covered:

• The FDA itself, from staff reductions to its regulatory agenda and how it might conduct 503B inspections
• Compounded GLP-1s, of course. We reiterated how successful it was for patients, talked about the scale of the shortage, and provided some reality checks on issues from drugmaker misinformation to patient sticker shock.
• 503B sourcing, including clarifying nomenclature to the next steps for the agency’s draft guidance
• The DDC list — the agency’s proposals and how drugmakers are trying to use it to prohibit GLP-1 compounding
• Ketamine best practices and the need for FDA to consider patient outcomes

We don’t expect to hear back from the FDA about any of these, at least not directly. The important thing was that we’re able to keep our concerns in front of the agency … and know they listened to us.