An FDA panel weighs letting pharmacies make seven popular peptides

A panel of outside experts convened by the FDA meets on July 23 and 24 to weigh whether seven peptides, among them BPC-157, TB-500 and MOTS-C, should join the compounding list that lets pharmacies make a substance legally. The agenda pairs them with migraines, ulcerative colitis and osteoporosis.

Peptides are short strings of amino acids that act as signaling molecules for metabolism and the immune system. None of the seven has been through the large-scale human trials the agency requires, and much of the evidence comes from preclinical work in animals. Agency scientists read that same file last month and recommended against moving any of them.

Who sits on the panel is the sharper question. Many members have ties to the peptide industry and work for clinics that offer these injectables, which a Harvard expert on agency law reads as a committee assembled around a viewpoint rather than the evidence. Health officials say every member cleared an ethics and vetting process.

Industry makes an economic argument: many of these molecules cannot be patented, so the cost of a decisive trial falls on nobody with a reason to carry it, and patients wait on a rule instead of a result. Panel recommendations are advisory, and agency leadership has the final say.

Read the full story at NPR ↗

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