Key facts
- An FDA advisory panel voted against adding the peptide emideltide to a list for broader pharmacy compounding.
- Seven panel members voted against the recommendation, while six voted in favor.
- The committee reviewed seven peptide compounds, including emideltide, BPC-157, and TB-500.
- These peptides have not undergone large-scale trials for FDA drug approval.
- Proponents argue current restrictions fuel a black market for peptides.
An advisory panel to the U.S. Food and Drug Administration has voted against recommending the peptide emideltide for inclusion on a list that would permit broader pharmacy compounding. The vote was close, with seven members voting against the recommendation and six voting in favor, while one member abstained.
The Pharmacy Compounding Advisory Committee met to discuss whether a dozen peptide drugs should be eligible for compounding by licensed facilities. These peptides are used for various conditions, including opioid use disorder, wound healing, insomnia, and ulcerative colitis. Emideltide itself was being considered for opioid withdrawal, chronic insomnia, and narcolepsy.
Many of these peptides have not undergone the rigorous large-scale trials required for FDA drug approval, leading to safety concerns from some experts. Proponents, however, argue that current restrictions have driven demand into a "gray market" of overseas suppliers, potentially exposing consumers to unvetted substances. They advocate for regulatory changes to ensure quality and safety through legal compounding channels.
Health Secretary Robert F. Kennedy Jr. has publicly supported lifting restrictions on peptides, claiming the FDA illegally reclassified certain peptides as unsafe. He believes that reintroducing them to the compounding list would create a legal market for safer, quality-sourced products. The FDA is reviewing seven specific peptides in July, with plans to discuss five additional peptides before February 2027.