A Food and Drug Administration advisory panel voted on peptides under consideration for compounding pharmacy manufacture during a two-day meeting that highlighted tensions between the Make America Healthy Again movement and mainstream scientists.
On Thursday, the panel voted to recommend adding four peptides to the list of substances available for compounding. The votes included 8-6 to add BPC-157 for treating ulcerative colitis, 7-5 to add KPV for wound healing and inflammatory conditions, 7-5 to add TB-500 for wound healing, and 7-5 to add MOTS-c for obesity and osteoporosis. On Friday, the panel voted 7-4 to recommend adding epitalon for insomnia and 8-5 to recommend adding semax for migraines and neurological conditions. However, emideltide, proposed for opioid withdrawal, chronic insomnia, and narcolepsy, failed to gain approval with a vote of 6-7 against.
FDA career staff members recommended against all peptides due to insufficient clinical evidence demonstrating safety and efficacy. Agency experts emphasized that adding peptides to compounding lists would constitute a dangerous experiment, noting that once substances are added, the FDA lacks authority to require compounders to submit safety or efficacy data. Mary Thanh Hui, director of the Office of New Drugs, stated the agency cannot mandate such submissions for grey market substances.
Panelists who voted in favor, many with industry ties, argued they were not voting to approve drugs and therefore did not need to consider robust clinical data requirements. Several emphasized their desire to serve individual patients seeking these substances. FDA officials noted that the administration will publish its decision as a proposed rule allowing public comment before final determination, and health secretary Kennedy could potentially overrule career staff recommendations.
Article Attribution | Read More at Article Source
Article summary produced by Claude AI