During a meeting last week, the Food and Drug Administration’s Pharmacy Compounding Advisory Committee recommended that six previously restricted peptides be made available for pharmacy compounding.
Peptides are short chains of amino acids, the building blocks of proteins. Compounding is the preparation of customized medications for individual patients rather than the dispensing of conventionally manufactured, FDA-approved drugs.
The committee endorsed BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax — substances promoted for conditions ranging from ulcerative colitis and wound healing to obesity, osteoporosis, insomnia, and neurological disorders. Only emideltide was rejected, 7-6.
Every affirmative vote was close: 8-6, 8-6, 8-6, 7-5, 7-4, and 8-5. That pattern deserves scrutiny. A scientific committee applying a consistent evidentiary standard to seven substances supported by widely varying data should not produce a succession of nearly identical cliffhangers. The uniform margins suggest that something other than case-by-case evaluation of the evidence was driving the results.
The explanation is not subtle.
Shortly before the meeting, eight new members were named to the committee. According to news reports, six had sold peptides or were affiliated with clinics, pharmacies, or companies operating in the peptide market. These were not merely scientists with distant “industry ties.” They were active market participants voting on whether to expand the market in which they worked.
Dr. Gabriel Alizaidy, for example, is the scientific director of Maximus Health, a telehealth company offering peptide-related services, and has charged for consultations about peptides and where to obtain them. The FDA has warned Maximus over misleading claims involving compounded GLP-1 products.
Another appointee, Tennessee state Sen. Bobby Harshbarger, is a pharmacist in his family’s compounding business. His mother, Rep. Diana Harshbarger (R-TN), had written to Health and Human Services Secretary Robert F. Kennedy Jr. requesting that restrictions be relaxed on several peptides, including BPC-157 and TB-500.
HHS responded to criticism by saying all members underwent the standard ethics review. That describes a process, but it does not dispel the appearance of conflicts. A panel is not independent and conflict-free merely because its members completed the requisite paperwork.
Dr. Peter Lurie, a former FDA associate commissioner and current president of the Center for Science in the Public Interest, aptly described the episode as “an extraordinary abuse of the advisory committee process to secure ends that have no basis in science.”
During my 15 years at the FDA, as a medical reviewer, special assistant to the commissioner, and office director, I never witnessed anything comparable.
The votes are especially indefensible because FDA career scientists had reviewed all seven peptides and recommended against listing every one. The committee overruled them six times.
Evidence of safety and efficacy was scarce or nonexistent. For several peptides, the FDA found no human exposure data for the proposed routes of administration. The available evidence consisted largely of laboratory experiments, animal studies, uncontrolled observations, and anecdotes — the sort of preliminary material that should prompt further research, not widespread clinical use.
FDA reviewers also raised concerns about immunogenicity, impurities, aggregation, and inadequate characterization of the active ingredients. Epitalon’s proposed effects on telomeres raised theoretical concerns about causing malignancies. For BPC-157, the FDA found only limited clinical evidence, including an abstract describing a small ulcerative-colitis study.
Dr. Brian Lee, a USC transplant hepatologist who voted against BPC-157, noted that placebo-response rates can approach 30% and concluded that the evidence presented did not convincingly exceed that benchmark. Cardiologist Eric Topol summarized the problem succinctly: “We’re missing safety, we’re missing efficacy — we’re missing the critical evidence.”
Compounding does not solve those problems. It adds others.
Compounded drugs are not FDA-approved, and their production is overseen primarily by state pharmacy boards. Russell Wesdyk, an FDA pharmaceutical-quality official, told the committee that the agency lacks authority to impose many of the purity-testing and adverse-event-reporting safeguards panelists said they wanted.
The supply chain is also murky. Investigations have traced online peptide sales to Chinese chemical manufacturers, including firms linked to commerce in fentanyl precursors. Transactions may occur through cryptocurrency and untraceable intermediaries. Incorrect amino-acid sequences, degradation, contamination, and dosing errors can be difficult to detect.
Supporters argued that pharmacy compounding would protect consumers currently buying peptides on the gray market. But legitimizing poorly studied substances is not a substitute for demonstrating that they are safe and effective. Nor is inclusion on the compounding list easily distinguished, in the public mind, from an FDA endorsement.
EVIDENCE VS INFLUENCERS: THE FDA VOTE PUTTING PATIENTS IN DANGER
Kennedy has said the FDA should “do the science” and inform the public but not dictate to physicians what they may prescribe or to patients what they may take. That is a philosophy of medical freedom, not a scientific standard — and it disregards the consumer-protection purpose and requirements of the federal drug laws.
The committee’s recommendations are not binding. The FDA can reject them, and it should. Approving medicines by assembling a panel of enthusiasts and commercial participants, then overriding the agency’s own scientists, is not regulatory reform. It is regulatory surrender.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished scholar at the Science Literacy Project. He was the founding director of the FDA’s Office of Biotechnology.