FDA advisory panel narrowly rejects compounding of one peptide, backs two others
Published by STAT
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A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide.
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The panel’s decision on Thursday recommended allowing pharmacies to make four other peptides.
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.
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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.
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Peptides, which are short-chain amino acids, have become increasingly popular in the U.S., driven by endorsements from social media influencers.
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The fundamental question facing panelists was whether it is acceptable to let individuals take medicines of unclear safety or efficacy.
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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.
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It is possible that Robert F. Kennedy Jr. or Kyle Diamantas could overrule career employees.
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.
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The administration will publish its decision as a proposed rule and give the public the opportunity to comment.
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FDA experts repeatedly stressed that adding the peptides to the section 503A bulk drug substances list would be a dangerous experiment, with physicians flying blind as far as dosing data and best prescription practices.
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They said the agency has no authority to require compounders to submit safety or efficacy data once a substance is added to the list.
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In the grey market, that’s not a requirement to be sent to us.
“In the grey market, that’s not a requirement to be sent to us,” said Mary Thanh Hai, director of the Office of New Drugs.
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Even getting on to the 503A compounding list, that isn’t a requirement.
“Even getting on to the 503A compounding list, that isn’t a requirement.”
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Panelists who voted yes said they did not have to consider the lack of robust clinical data.
They said because they were not voting to approve a drug, they did not have to consider the lack of robust clinical data.
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Several said they wanted to satisfy their individual patients who have been clamoring for these substances.
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Asare Christian said that dosing, efficacy, and safety are not what the panel has been asked to do.
“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.
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On Thursday, the panel voted 8-6 to add BPC-157 to the list for treating ulcerative colitis, to add KPV for wound healing and inflammatory conditions, and to add TB-500 for wound healing.
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The panel voted 7-5 to add MOTS-c to the list for obesity and osteoporosis.
The panel voted 7-5 to add MOTS-c to the list for obesity and osteoporosis.
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On Friday, the panel voted 7-4 to add epitalon to the list for insomnia.
On Friday, the panel voted 7-4 to add epitalon to the list for insomnia, again voting along similar lines.
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The vote on adding semax for migraines and neurological conditions was 8-5.
The vote on adding semax, for migraines as well as the neurological conditions cerebral ischemia and trigeminal neuralgia, was 8-5.
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Emideltide failed voting passage by a tally of 6-7.
But emideltide, under consideration for opioid withdrawal, chronic insomnia, and narcolepsy, failed voting passage by a tally of 6-7.
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David Pope said he was concerned about emideltide’s potentially dangerous downstream consequences.
He said he was concerned about emideltide’s “potentially dangerous downstream consequences.”
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During public comments, the peptide semax had some especially vociferous supporters, who noted that there is more data on the drug than many other peptides under discussion because it’s approved in Russia for clinical use.
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But FDA staffers said their review of research found insufficient evidence to support its use for the conditions in question.
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The article has been updated to add the vote on semax.
This article has been updated to add the vote on semax.
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