FDA adds peptide advocates to compounding panel
FDA documents show nine new advisers were added before meetings on whether compounders may make several contested peptide drugs.
By James Whitfield · Staff Writer
3 min read
Federal health officials have added nine members to an FDA advisory committee that is about to review wider access to several injectable peptide drugs. FDA staff, in briefing documents released for the meetings, said the products still lack enough evidence of safety and effectiveness for the uses under review.
The Food and Drug Administration updated the roster of its Pharmacy Compounding Advisory Committee on Monday. According to the FDA list and public clinic pages, most of the new members promote peptide use, work with clinics that offer peptide treatments, or have other ties to businesses in the wellness and longevity market.
The committee now has 13 members, including the nine new appointees. Health Secretary Robert F. Kennedy Jr. has publicly supported peptides, calling himself a “big fan” on X and saying he wanted to end what he described as the FDA’s “aggressive suppression” of them.
Meetings set for July
The FDA says the committee will meet July 23 and 24 to discuss whether seven peptide substances should be allowed for use by compounding pharmacies. Compounding pharmacies make customized medicines, but the FDA currently does not allow the peptides at issue to be compounded for human use, according to agency materials.
On July 23, the advisers are scheduled to consider BPC-157 for ulcerative colitis, KPV for wound healing and inflammation, TB-500 for wound healing, and MOs-C for obesity and osteoporosis. On July 24, the agenda lists emideltide for opioid withdrawal, chronic insomnia and narcolepsy; semax for cerebral ischemia, migraine and trigeminal neuralgia; and epitalon for insomnia.
The FDA says a later meeting, expected before the end of February 2027, will cover five more peptides. The agency said in its briefing materials that it will not make final decisions until it has considered the committee process and completed its reviews.
Advisory committee recommendations do not bind the FDA, but the agency often takes them into account. In 2023, FDA scientists found that the peptides lacked sufficient evidence of benefit and could raise safety concerns, according to agency documents.
New members and ties
The new roster includes Gabriel Alizaidy, scientific director at Maximus, a “personal performance medicine” clinic that offers peptide injections. The Washington Post reported that the FDA recently sent Maximus a warning letter over allegedly false or misleading peptide-related weight-loss claims.
Other new members include Asare B. Christian, founder of Aether Medicine in Pennsylvania, which describes peptide use in treatments for pain, injuries, anti-aging and neurological disease; Melissa Loseke, founder and medical director of Nebraska’s Re-New Institute, which advertises peptide treatments; and Haleem Mohammed, chief medical officer at Gameday Men’s Health, which offers peptide therapy.
The FDA roster also adds Gerald Morris, medical director at AMG Medical in Tucson, whose website cites an interest in regenerative medicine, peptide therapy and longevity; Josh Starbuck, a Hawaii concierge physician whose practice says it focuses on functional medicine and peptide therapy; and Kris Wusterhausen, founder of Texas-based The Resurge Clinic, which promotes peptide treatments.
Robert Harshbarger, a Tennessee Republican state senator and pharmacist, was also added. His mother, U.S. Rep. Diana Harshbarger, asked Kennedy in November to have the FDA revisit six peptides, according to a letter posted by the Alliance for Pharmacy Compounding. David Pope, chief pharmacy officer at XiFin Pharmacy Solution, is the ninth new member; the public materials reviewed did not show a clear public position from him on peptide use.
The four prior members listed by the FDA are Timothy Fensky of the National Association of Boards of Pharmacy, Elizabeth Rebello of MD Anderson Cancer Center, Brian Serumaga of U.S. Pharmacopeia and Donnette Staas of Jazz Pharmaceuticals, who serves as a non-voting industry representative.
This story draws on original reporting from Ars Technica.