When the HHS Office of the Inspector General comes calling, you show up – and you come prepared. APC was invited to participate in a listening session this week as part of OIG's ongoing evaluation of GLP-1 compounding, and we made the most of the opportunity.
The framing we brought: what happened with GLP-1s was a genuine confluence of events unlike anything in recent memory. A new drug. A prolonged shortage. A price point that put the branded product out of reach for most patients, with insurance coverage that largely didn't exist. Into that gap stepped compounding pharmacies – meeting demand that manufacturers couldn't, at a price patients could actually afford, with a track record of relative safety.
From there, the conversation covered the details any honest evaluation of this space requires: 503A adherence to FDA's “essentially a copy” guidance; the persistent conflation between legitimate, state-licensed compounding pharmacies and the illicit actors who were the actual source of most patient safety concerns; med spas operating outside the enforcement reach of state boards of pharmacy; the rise of telehealth and 503B sourcing to 503A pharmacies. We also flagged concerns about how FAERS data and FDA statements have been used – and on the elevated scrutiny around API quality and advertising claims, we drew a distinction that often gets lost: some of those concerns are legitimate. Some are not.
APC will continue to engage as OIG's evaluation moves forward, but getting our perspective into that room early was a great win.