FDA advisory panel backs compounding of unapproved peptides BPC-157 and KPV
An FDA advisory panel voted narrowly to recommend that compounding pharmacies be permitted to produce the unapproved peptides BPC-157 and KPV.
The recommendation is seen as a victory for supporters of peptide therapies and for health secretary Robert F. Kennedy Jr., who has advocated for broader access.
The panel’s vote is non-binding; the FDA still must decide whether to lift existing restrictions on these compounds. The agency will also consider two additional peptides, TB-500 and MOTS-c, later the same day, with further compounds slated for review on Friday.
Most panelists who voted in favor have ties to the peptide industry, raising questions about potential conflicts of interest as the FDA evaluates the safety and efficacy of these largely unstudied substances.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: In win for RFK Jr., FDA advisory panel narrowly votes to allow compounding of unapproved peptides”
read at STAT ↗
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