FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next?
Summary
An FDA advisory committee voted narrowly to recommend adding six peptides to a list that allows pharmacies to make custom drugs containing them. The vote is not final and still needs approval from the FDA, with debate ongoing about safety and scientific evidence.Key Facts
- The FDA’s Pharmacy Compounding Advisory Committee voted to add six peptides: BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax.
- The vote is advisory and non-binding, requiring final approval by the FDA.
- Peptides are small chains of amino acids used in some approved medicines like insulin, but many peptides lack strong clinical testing.
- The panel rejected adding a seventh peptide, emideltide, due to weak evidence and existing treatments.
- Six of the eight committee members currently run clinics offering peptides, showing some conflict of interest concerns.
- FDA scientists opposed adding the peptides due to insufficient data and risks like inconsistent production and immune reactions.
- Supporters argue adding peptides could reduce harm by moving use away from unregulated black markets.
- Adding peptides to the compounding list does not make them FDA-approved drugs or available as over-the-counter supplements.
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