By Sneha S K
June 30 (Reuters) – U.S. FDA staff reviewers said there is little evidence to allow compounding pharmacies to manufacture seven popular peptides, in stark contrast to Health Secretary Robert F. Kennedy Jr, who has publicly endorsed the compounds and said he is a “big fan”.
The remarks, outlined in documents the U.S. Food and Drug Administration released on Monday, come ahead of a July 23 to 24 meeting of its Pharmacy Compounding Advisory Committee, which will consider whether to add the peptides to the agency’s list of bulk drug substances permitted for use in compounded medicines.
Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body. If permitted, compounding pharmacies can manufacture them for personalized medications tailored to patients’ unique needs.
Peptides have gained mass popularity over the past year, fueled by a surge in interest in wellness and longevity and by influencer endorsements, despite limited evidence on their safety and efficacy and a lack of adequate human studies.
The reviewers’ concerns over the limited clinical evidence supporting peptides, as well as the lack of sufficient human trials, diverge sharply from Kennedy’s position. He has said he used them with “really good effect.”
At its July 23 to 24 meeting, the committee will weigh whether compounding pharmacies should be permitted to manufacture seven peptides, including BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis treatment.
The panel will also consider emideltide for opioid withdrawal and chronic insomnia, semax for conditions such as cerebral ischemia, migraines, and chronic pain, and epitalon for insomnia.
While the committee’s recommendations are non-binding, they are expected to inform the FDA’s final decision.
FDA staff reviewers highlighted that evidence supporting peptides’ effectiveness and safety for their proposed uses is limited and also flagged the lack of human trials.
PANELISTS’ LINKS TO PEPTIDE INDUSTRY
The FDA also appointed several new members to the panel that will review whether the peptides may be used in compounded drugs. Seven of the committee’s 14 members have ties to businesses or clinics involved in peptide therapies.
Among them is Melissa Loseke, who owns a wellness clinic in Omaha, Nebraska that provides personalized, “concierge” care in hormone therapy, sexual wellness and regenerative aesthetics.
Gabriel Alizaidy is the scientific director at Maximus Health, which offers GLP-1 microdosing protocols and growth hormone peptides.
Another panelist, Robert Harshbarger, is a Tennessee senator and licensed pharmacist. His mother, Congress member Diana Harshbarger, wrote to Secretary Kennedy last year to loosen FDA restrictions on the production of peptides.
Panel member Asare Christian’s clinic offers patients peptide therapies for pain relief, muscle growth, and longevity.
Also part of the panel is Haleem Mohammed, global chief medical officer at Gameday Men’s Health, with over 400 clinics across the U.S., that offers sermorelin peptide injections, currently not on any FDA restricted list.
(Reporting by Sneha S K in Bengaluru; Editing by Diti Pujara)
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