A U.S. Food and Drug Administration (FDA) advisory committee voted against FDA staff recommendations on July 23, suggesting that two peptides, BPC-157 and KPV, be included on the 503A bulks list. This would permit certain specialty pharmacies to dispense them, moving them out of a current legal gray area. This move is considered unusual as FDA panels typically align with the agency's recommendations, and it paves the way for a lengthy public rulemaking process, though it is not a binding decision.
The committee's decision is controversial, especially given that the FDA had essentially banned compounding pharmacies from dispensing seven peptides, including BPC-157, KPV, TB-500, and MOTS-C, in 2023 due to "significant safety risks." Advocates for peptides argue that this ban has pushed consumers to riskier, unregulated sources, such as suppliers in China or even bodegas. Companies like Hims & Hers and Noom publicly advocated for peptides to be made available through compounding pharmacies to ensure safer access.
FDA staff had voiced concerns that the evaluation criteria weighed against placing BPC-157 and KPV on the list, citing limited evidence of their effectiveness and the existence of FDA-approved alternatives for conditions like ulcerative colitis. For BPC-157, the only trial FDA staff found involved 46 people, with the peptide administered as an enema, not an injection. Critics, including former FDA officials, warn that allowing peptides to be compounded could disincentivize companies from pursuing the rigorous and evidence-based FDA drug approval process. Financial analysts forecast a potential $2.2 billion telehealth marketing opportunity if these seven peptides are approved for compounding, with Hims & Hers stock reportedly rising over 10% after the BPC-157 vote.
