By Sneha S K
June 30 (Reuters) – The U.S. Food and Drug Administration’s staff reviewers said available evidence does not support allowing compounding pharmacies to manufacture seven popular peptides.
The remarks, outlined in documents the U.S. FDA released on Monday, come ahead of a July 23-24 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.
These have surged in popularity over the past year, driven by wellness influencers who promote them for a range of uses despite limited evidence on their safety and efficacy and a lack of adequate human studies.
At its July 23–24 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 for their proposed uses is scant and also flagged the lack of human trials.
In 2023, the Biden Administration had barred compounding pharmacies from manufacturing peptides for the same reasons, citing risks related to immunogenicity, toxicity and impurity.
However, the reviewers’ remarks contrast with the views of Health Secretary Robert F. Kennedy Jr, who has publicly endorsed the use of peptides and has said he is a “big fan” and has used them himself with “really good effect.”
The FDA also named new members to the panel that will review the peptides, many of whom have ties to peptide-related businesses and clinics. They include Melissa Loseke, who owns a wellness clinic in Omaha, Nebraska and Gabriel Alizaidy, scientific director at Maximus Health, which offers GLP-1 microdosing protocols and other peptide therapies.
(Reporting by Sneha S K in Bengaluru; Editing by Diti Pujara)
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