Physicians and drug-safety groups criticised the U.S. Food and Drug Administration on Saturday after one of its advisory panels narrowly recommended adding the peptide BPC-157 to a list permitting pharmacy compounding, despite the compound lacking FDA approval. The vote drew immediate scrutiny over the agency's evidence standards.
The recommendation came from the FDA's Pharmacy Compounding Advisory Committee, which met Thursday to review a group of bulk drug substances. BPC-157, a synthetic peptide promoted by podcaster Joe Rogan and other online figures for muscle and joint recovery, has never been tested in large human clinical trials or approved for any medical use in the United States.
Shares in telehealth company Hims & Hers Health rose sharply after the vote, climbing roughly 13 percent on Thursday, as investors anticipated new demand for compounded peptide products. Analysts at several firms linked the rally directly to expectations that clinics and compounding pharmacies would expand offerings of the substance.
Critics, including members of the advisory panel who voted against the measure, warned that endorsing a compound with limited safety data risked legitimising products marketed through social media rather than clinical evidence. The FDA is not bound by the committee's recommendation and must issue a final decision before any change takes effect.
Consumer-safety organisations urged the agency to require rigorous toxicology and human trial data before permitting wider distribution. The debate highlighted tension between influencer-driven wellness markets and traditional regulatory review of experimental therapies.