FDA revamps peptide panel with industry advocates

 The FDA has released the names of panel members who will weigh in on whether seven popular peptides should be more widely available for pharmacy compounding. The new roster mainly includes physicians who run wellness, longevity and regenerative medicine clinics rather than the university researchers who staffed prior panels. 

The Pharmacy Compounding Advisory Committee will meet July 23 and 24 to decide whether seven peptides widely sold by wellness clinics and online retailers — including BPC-157 and TB-500 — should be added to the list of bulk drug substances pharmacies are permitted to use in compounding. The panel’s recommendations are non-binding, but the FDA generally follows them.

Since 2023 previous committees with similar makeups have voted down peptide ingredients on safety and evidence grounds. This year, the FDA has restructured the reviewing panel, and its own staff have already published findings on two of the seven substances under review, both recommending against approval. Here’s what to know: 

1. The panel skews toward peptide promoters, not academics. Eight of the committee’s 12 voting members run private wellness, longevity or regenerative medicine clinics, including physicians from Aether Medicine, a cellular medicine and regenerative therapies clinic in Wayne, Pa., Re-New Institute, a regenerative medicine practice in Omaha, Neb., Makena Health, an internal medicine practice in Wailea, Hawaii, and The Resurge Clinic, a family practice in Weatherford, Texas, among others. 

2. Several panelists have direct financial ties to the peptide and regenerative medicine industry. Haleem Mohammed, MD, is global chief medical officer at Chicago-based Gameday Men’s Health, a clinic chain that sells peptide, vitamin and weight loss injections. Robert Harshbarger III, PharmD, a Tennessee state senator appointed under the committee’s pharmacy expertise seat, is a pharmacist whose family runs a compounding pharmacy business. Gabriel Alizaidy, MD, is scientific director at Maximus Health, a Des Moines, Iowa-based clinic. According to a June 29 report from the Associated Press, he separately promotes peptides including BPC-157 to followers on social media and charges for consultations.

3. FDA staff reviewers recommend against approval for the substances they’ve evaluated so far. Briefing documents released ahead of the meeting concluded the evidence weighs against adding BPC-157 and TB-500 to the agency’s list of bulk drug substances approved for compounding. For BPC-157, reviewed for ulcerative colitis, FDA cited a single small, poorly documented trial and no human data at all for the oral, subcutaneous, nasal or transdermal routes proposed. For TB-500, reviewed for wound healing, FDA found zero human studies of any kind and no nonclinical evidence the substance promotes healing.

4. Both substances under review have characterization and safety gaps. FDA reviewers flagged inconsistent naming conventions, incomplete impurity testing and unclear sterility data for both peptides, along with unaddressed immunogenicity risk from aggregation when delivered by injection. The committee will also review KPV, MOTs-C, Emideltide, Semax and Epitalon at the meeting.

5. The reshaped panel breaks from a pattern of past committees voting down peptides on safety grounds. The committee’s December 2024 meeting, for example, drew voting members from Durham, N.C.-based Duke University, the University of California, Riverside, the NIH’s National Institute of Mental Health, the Uniformed Services University and Boston Children’s Hospital, among other academic and federal institutions. Those panels voted against a string of nominated peptide ingredients citing weak evidence. HHS Secretary Robert F. Kennedy Jr., who told podcast host Joe Rogan he is “a big fan of peptides,” according to the Associated Press, fired all 17 members of the CDC’s Advisory Committee on Immunization Practices in June and has since appointed about a dozen new members, many with a history of anti-vaccine rhetoric. 

https://www.beckershospitalreview.com/glp-1s/fda-revamps-peptide-panel-with-industry-advocates-5-things-to-know/