FDA digs into APC’s peptide proposal

Monday’s listening session with FDA staff brought a substantive discussion of APC’s proposed guardrails for peptide compounding, with several incisive questions about technical details. Board Chair Philip Smyth, Advocacy Chief Tenille Davis, and CEO Scott Brunner presented for APC. Research partner Dr. Donghai Liang of Emory University’s Rollins School of Public Health also presented a framework for limited utilization reporting if FDA authorizes compounding of selected peptides.

APC’s proposal asks FDA to use interim enforcement discretion to permit patient-specific compounding of selected peptides under strict conditions: validated sourcing of cGMP-compliant active ingredients, USP-compliant preparation, enhanced patient disclosures, serious adverse-event reporting and limited utilization reporting. That approach would preserve carefully controlled access while additional safety evidence is developed.

“After two listening sessions on this topic, my sense is that FDA is seriously considering an interim framework much like what we've proposed, and they're quite interested in our technical assistance,” said Brunner.