The FDA's Pharmacy Compounding Advisory Committee recently voted to recommend that several unapproved peptides, specifically BPC-157, KPV, TB-500, and MOTS-c, be added to a list that would enable compounding pharmacies to dispense them. This decision, made on Thursday, July 23rd, and Friday, July 24th, comes despite strong opposition from FDA scientists and staff who had previously banned these peptides in 2023 due to significant safety concerns and lack of rigorous testing regarding their purported uses. The committee's recommendations are not binding, and the peptides will still undergo a lengthy public rulemaking process before potentially being added to the 503A bulks list.
For BPC-157, KPV, and TB-500, eight members of the committee voted in favor, six against, and one abstained. For MOTS-c, seven members voted affirmatively, five negatively, and two abstained. Notably, many of the "yes" votes came from committee members who have ties to or are employed by telehealth companies, which are predicted to benefit financially. For example, Him & Hers stock reportedly rose over 10% after the BPC-157 vote, and financial analysts project a potential $2.2 billion telehealth market opportunity if these peptides are approved for compounding. FDA scientists had reviewed these peptides for specific uses: BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis.
The committee's decision was described as "highly unusual" as it went against the FDA staff's own advice. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner, voiced concerns that allowing compounding would remove incentives for companies to go through the rigorous FDA drug approval process, potentially compromising safety and effectiveness evidence. Public health groups also expressed worry about the reduced oversight of compounded medications compared to FDA-approved drugs, citing higher rates of adverse effects and reporting errors for compounded products in a recent study. Advocates for peptides, however, argued that strict regulations have pushed consumers to unsafe gray markets, including foreign suppliers, and that allowing compounding could provide a safer, regulated alternative.
