FDA advisory panel votes to ease compounding restrictions on four peptides

The FDA’s Pharmacy Compounding Advisory Committee voted to recommend that four peptides – BPC-157, KPV, TB-500 and MOTS-c – be allowed for preparation by compounding pharmacies. The recommendation does not make the substances FDA-approved drugs; a final rule will still be required from the agency.

Committee members were appointed by Health Secretary Robert F. Kennedy Jr., including six clinicians who run peptide-offering clinics. During the daylong meeting, FDA career scientists presented data gaps and safety concerns, noting that the chemical structures of many peptides are not universally defined, which hampers regulatory assessment.

“We’ve never faced a problem of, ‘What is it?’” – Russell Wesdyk, FDA official

Proponents argued that allowing compounding would move users away from the unregulated “research-only” market. Votes on the four peptides were close: all eight new appointees voted yes on BPC-157, KPV and TB-500, while the vote on MOTS-c was 7-5 with two abstentions.

Committee members expressed divergent views. Dr. Gabriel Alizaidy, a clinical researcher at an online clinic, voted yes for BPC-157 despite “incomplete data.” Dr. Haleem Mohammed, chief medical officer at a men’s health clinic, said his vote was driven by concerns for patient safety and “medical freedom.”

“As a physician, I have to make sure that I’m keeping patients as safe as possible… saying no and pushing it to the gray market, am I doing greater harm?” – Dr. Haleem Mohammed

Opponents warned that the lack of robust evidence could mislead the public into viewing the votes as endorsements. Dr. Brian Lee, an associate professor of medicine, voted no, citing the high placebo response rate in trials. Dr. Elizabeth Rebello, an anesthesiologist at MD Anderson, expressed concern that the review was driven by market demand rather than solid science and highlighted the ethical dilemma of endorsing products with unknown risks.

“I’m concerned that we’re responding to a market-induced demand rather than a decision based on solid science.” – Dr. Elizabeth Rebello

The panel’s recommendation will be forwarded to the FDA for a rulemaking proposal that could permit compounding pharmacies to produce the four peptides under specified conditions.