WASHINGTON — On Friday, a Food and Drug Administration advisory panel recommended that compounding pharmacies be authorized to produce the peptides epitalon and semax. However, they narrowly voted against the production of emideltide.
This decision followed Thursday’s recommendation to allow the manufacture of four additional peptides, advancing health secretary Robert F. Kennedy Jr.’s objective of increasing access to these unapproved compounds for Americans. Peptides, known for their short-chain amino acid structure, have gained popularity in the U.S., fueled by social media influencer endorsements.
The two-day session underscored existing tensions between the Make America Healthy Again movement and mainstream scientific views. The core issue debated was whether it is acceptable to permit individuals to use medications without clear evidence of safety or effectiveness.
The FDA is not obligated to follow the panel’s recommendations. During the discussions, FDA staff advised against permitting compounders to proceed due to insufficient clinical evidence supporting safety and efficacy.
Normally, such decisions would be made by career staff members. However, due to Kennedy’s involvement and the Trump administration’s history of political influence over scientific matters, he or acting FDA commissioner Kyle Diamantas might override the career staff. The administration plans to publish its decision as a proposed rule and will invite public comments.
FDA experts cautioned that adding these peptides to the section 503A bulk drug substances list could be risky, likening it to an experiment where physicians would lack adequate dosing and prescription guidelines. The agency lacks the authority to demand safety or efficacy data from compounders once a substance is added to the list.
“In the grey market, that’s not a requirement to be sent to us,” explained Mary Thanh Hai, director of the Office of New Drugs. “Even getting on to the 503A compounding list, that isn’t a requirement.”
Those who voted in favor, many of whom have connections to the peptide industry and were appointed by the Health and Human Services Department, offered a different perspective. They argued that since they were not approving a drug, they did not need to consider the absence of comprehensive clinical data. Several panelists expressed a desire to meet their patients’ demands for these substances.
“We’re talking about dosing and efficacy and safety, and it doesn’t look like that’s what we’ve been asked to do,” said Asare Christian, founder of wellness clinic Aether Medicine. “As a physician, my view is through the lens of the patient in front of me.”
On Thursday, the panel voted 8-6 to include BPC-157 for ulcerative colitis treatment, KPV for wound healing and inflammatory conditions, and TB-500 for wound healing. They also voted 7-5 to add MOTS-c for obesity and osteoporosis. Those opposed mainly included physicians from academic institutions and patient representatives.
On Friday, the vote was 7-4 in favor of adding epitalon for insomnia. Semax was approved with an 8-5 vote for migraines as well as neurological issues like cerebral ischemia and trigeminal neuralgia.
However, emideltide, proposed for treating opioid withdrawal, chronic insomnia, and narcolepsy, was rejected with a 6-7 vote.
David Pope, chief pharmacy officer at XiFin Pharmacy Solution, joined the dissenters after initially supporting the previous peptides, citing concerns over emideltide’s “potentially dangerous downstream consequences.”
During public comments, semax had vocal supporters who pointed out that it is approved for clinical use in Russia, providing more data than other peptides discussed. Yet, FDA staffers maintained that the research did not sufficiently support its use for the proposed conditions.
This article has been updated to include the vote on semax.
