FDA advisory panel narrowly rejects compounding of one peptide, backs two others
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- The FDA advisory panel voted 7-4 Friday to add epitalon for insomnia, 8-5 for semax (migraines, cerebral ischemia, trigeminal neuralgia), and rejected emideltide 6-7 for opioid withdrawal, chronic insomnia, and narcolepsy.
- Thursday's session produced 8-6 votes to add BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, and TB-500 for wound healing, plus 7-5 to add MOTS-c for obesity and osteoporosis.
- FDA staff uniformly recommended against all seven peptides, citing a lack of clinical safety and efficacy evidence and warning that physicians would be "flying blind" on dosing and best practices.
- Panelists who voted yes mostly had ties to the peptide industry and were appointed by HHS; dissenters were largely physicians from academic institutions and patient representatives.
- David Pope of XiFin Pharmacy Solution joined the emideltide dissenters after voting with the majority on prior peptides, citing "potentially dangerous downstream consequences."
- Robert F. Kennedy Jr. or acting FDA commissioner Kyle Diamantas retain authority to overrule career FDA staff, with the administration set to publish its decision as a proposed rule with a public comment period.
Why it matters: FDA career staff uniformly warned of safety risks from all seven peptides, yet a panel stacked with HHS appointees and peptide-industry ties greenlit six of seven — meaning the final call falls to Kennedy Jr. and Diamantas, who can override career scientists without any compounders ever having to submit safety or efficacy data once on the 503A list.
