WASHINGTON — A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptide epitalon, but narrowly voted to recommend against manufacturing emideltide.
The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring health secretary Robert F. Kennedy, Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides, which are short-chain amino acids, have become increasingly popular in the U.S., driven by endorsements from social media influencers.
The two-day meeting highlighted broader tensions between the Make America Healthy Again movement and mainstream scientists. The fundamental question facing panelists was whether it is acceptable to let individuals take medicines of unclear safety or efficacy.
The FDA does not have to listen to the panel’s advice. For each peptide under consideration, FDA staff told the panelists they recommended against giving compounders the green light due to a lack of clinical evidence demonstrating safety and efficacy.
Typically this type of decision would be made by those same career staff members. But given Kennedy’s interest in the matter and the Trump administration’s propensity to allow politics to influence science, it is possible that he or acting FDA commissioner Kyle Diamantas could overrule career employees. The administration will publish its decision as a proposed rule and give the public the opportunity to comment.
