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A divided panel of experts aligned with health secretary Robert F Kennedy Jr defied the US drug regulator’s scientists and voted to broaden public availability of a controversial drug popular on social media.
At a meeting at the US Food and Drug Administration in Maryland, the panel voted eight to six to end prohibitions for a peptide known as BPC-157, also called the “Wolverine” peptide on social media, disregarding the recommendations of the FDA’s own staff who said the scientific evidence weighs against broadening access.
The vote came after the panel was reconstructed under Kennedy’s leadership to include pharmacists and doctors who stand to benefit from selling peptides, and at least six members who have ties to the industry. Another new member who voted in favour of deregulation, Tennessee state senator Bobby Harshbarger, is the son of Republican Congress member Diana Harshbarger, a pharmacist who has advocated peptide use.
The vote to advance peptides comes as investors are closely watching the niche market as a lucrative business opportunity. Pharmacy businesses have said they have been contacted by investors ahead of potential regulatory change, and the peptides market could grow to a multibillion-dollar opportunity, according to Wall Street estimates.
BPC-157 is one of seven peptides the FDA panel is considering for deregulation on Thursday and Friday. These peptides are strings of amino acids common in regulated weight-loss drugs such as Ozempic. Peptides are injected like most weight-loss drugs.
Initial studies of BPC-157 in animals and cells have shown the drug may reduce inflammation in muscles and tendons and speed fracture healing. These outcomes have made the drug popular among bodybuilders as well as the online “looksmaxxing” subculture.
The FDA said it was not clear what BPC-157 actually is — an initial question for the agency before considering its approval. The drug is not part of an approved product in any country, and it is listed on the World Anti-Doping Agency’s prohibited list, the agency said. Risks of the drug include ulcerative colitis, an inflammatory bowel disease.
Kennedy has promoted peptides and praised their potential. His support suggested peptide availability was inevitable despite the FDA’s objections, said Paul Kim, a partner at Kendall Square Policy Strategies, a consultancy.
“This is not about the science at all,” Kim said after the BPC-157 vote. “This is a purely political exercise.”
These peptides are currently available in the US through regulatory loopholes and are typically shipped from China.
At the meeting, pharmacy businesses, doctors and others criticised the FDA’s analysis as incomplete. Supporters said the drugs were already widely available on the unregulated grey market and should be made in the US at pharmacies so the drugs can be sold safely.
The panel’s vote is nonbinding and the FDA could still refuse to broaden access for BPC-157. But Kennedy was likely to over-rule any FDA rejections for peptides, said Edgar Asebey, partner at law firm Frier Levitt in Florida.
“The committee may be giving cover for Kennedy to take this action,” he said. The FDA historically has not disagreed with its own scientists, but with the vote “I think it is more creating a cover for Secretary Kennedy to do this on his own,” Asebey said.
“Nowadays political preferences have become much more prominent and have led to policy changes.”
