WASHINGTON — A Food and Drug Administration advisory committee recommended Friday that compounding pharmacies be allowed to make the peptide epitalon, but narrowly voted against recommending that they make emideltide.
The vote follows the committee’s decision Thursday to recommend allowing pharmacies to manufacture four other peptides, bringing Health Secretary Robert F. Kennedy Jr. one step closer to his mission to make these unapproved compounds more accessible to Americans. Peptides, short-chain amino acids, are becoming increasingly popular in the United States with support from social media influencers.
The two-day conference highlighted broader tensions between the “Make America Back to Health” movement and mainstream scientists. The fundamental question the panelists faced was whether it was permissible to put individuals on drugs whose safety and effectiveness were unclear.
Peptide epidemic reveals link between Americans and risk
FDA does not have to listen to the committee’s advice. FDA staff told panelists that they recommended not giving the green light to formulators for each peptide under consideration due to a lack of clinical evidence of safety and efficacy.
These types of decisions are typically made by staff members from the same career. But given Kennedy’s interest in the issue and the Trump administration’s propensity to allow politics to influence science, it is possible that he or acting FDA Commissioner Kyle Diamantas could overturn the career official’s decision. The administration will publish its decision as a proposed rule and give the public an opportunity to comment.
FDA experts have repeatedly emphasized that adding these peptides to the 503A bulk list is a risky experiment and leaves physicians blind to dosing data and prescribing best practices. They said the agency does not have the authority to require formulators to submit safety or efficacy data after a substance is added to the list.
“In the gray market, that’s not a requirement sent to us,” said Mary Tan Hai, director of the new pharmacy. “Even being on the 503A compounding list, that’s not a requirement.”
But the panelists who voted in favor, most of whom had ties to the peptide industry and were appointed by the Department of Health and Human Services, saw things differently. They said they don’t vote to approve drugs, so they don’t have to consider the lack of robust clinical data. Several said they wanted to satisfy individual patients seeking these substances.
“We’re talking about dosage and efficacy and safety, but that doesn’t seem to be what we’re being asked to do,” says Asare Christian, founder of wellness clinic Ether Medicine. “My perspective as a physician is through the lens of the patient in front of me.”
On Thursday, the committee voted 8-6 to add BPC-157 to the list of drugs to treat ulcerative colitis, KPV to wound healing and inflammatory conditions, and TB-500 to wound healing. The committee voted 7-5 to add MOTS-c to the obesity and osteoporosis list. The dissenting panelists primarily represented physicians and patients at academic institutions.
On Friday, the committee voted 7-4 to add Epitalon to the insomniac list, again voting along similar lines. However, emideltide, which is being considered as a treatment for opioid withdrawal, chronic insomnia, and narcolepsy, was rejected 6-7.
David Pope, chief pharmacy officer at XiFin Pharmacy Solution, joined the opposition after voting majority in favor of the previous peptide. He said he was concerned about emideltide’s “potentially dangerous downstream effects.”
