A Food and Drug Administration advisory committee hearing on Thursday and Friday may set Health and Human Services Secretary Robert F. Kennedy Jr., known for embracing unproven wellness trends, on a collision course with agency scientists who have deep expertise on drug safety.
At issue is whether the F.D.A. should allow specialized pharmacies to produce seven peptide injections that the agency banned three years ago over safety concerns. The injections, some of which Mr. Kennedy has used and trumpeted, are currently sold as “research grade” products not meant for widespread use. Despite the restriction, they are marketed online for a wide range of claimed benefits, from tendon repair to brain health.
In documents prepared for the hearing, F.D.A. scientists advise against allowing broader use, saying that the risks and benefits of the peptide drugs under consideration are poorly understood and have not been sufficiently studied.
The 19-member committee evaluating that data and other information includes a traditional roster of pharmacists and academic scientists and doctors — but also six people who sell or dispense peptides. F.D.A. advisory panels are intended to be neutral bodies of outside experts; it is highly unusual to appoint people to them who market the products that they are voting on.
“There seems to be a fingerprint of R.F.K. on this committee, is my impression,” said Paul Knoepfler, a University of California at Davis biologist who studies F.D.A. oversight of unproven treatments. He added: “To me, the makeup of this committee seems pretty striking.”
The Department of Health and Human Services defended the selections. “All committee members underwent the same ethics review and vetting process required of all FDA advisory committee members,” the department said in a statement. “Candidates that could not meet existing ethics requirements were removed from consideration.”
Soon after President Trump tapped Mr. Kennedy to take a health leadership role, Mr. Kennedy pledged to end the F.D.A.’s “war” on peptides and other restricted items. Thursday’s hearing begins the first potent test of whether he will follow through.
The outcome carries incredible weight, said Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School who studies agency oversight.
“It’s going to reposition the F.D.A. in a much weaker position if they cave to this kind of political pressure,” he said. “Because there’s no reason these peptides should be approved.”
F.D.A. advisory committee votes are nonbinding. A committee’s input is typically considered by F.D.A. scientists and officials who make a final recommendation to the agency’s commissioner. However, the health and human services secretary has the authority to overrule the agency’s decision.
That rarely happens, but in conversations about peptides, Mr. Kennedy has expressed an interest in making the final decision and has leaned toward adding the peptides back to the compounding list, according to two people familiar with the matter who were not authorized to speak publicly.
Peptides are chains of amino acids that prompt cells to perform actions like decreasing inflammation or increasing collagen production. Some peptides that have been fully vetted by the F.D.A. include drugs like insulin or GLP-1s.
But unproven peptides with names like BPC-157 and MOTS-c have gained a foothold on social media, where users show off their “stacks,” or combinations of peptides, and extol their virtues for weight loss, muscle building and glowing skin. They are often referred to as “peppers” to avoid content moderation.
Some are backed by studies in rodents or in a petri dish suggesting that they could help with wound healing, osteoporosis or inflammation. But a similarly limited set of studies suggests they could cause harm, such as severe allergic reactions or the potential to enhance tumor growth.
There is little to no data on how these peptides work in humans.
“We’re missing safety, we’re missing efficacy — we’re missing the critical evidence,” said Dr. Eric Topol, a cardiologist and the founder of the Scripps Research Translational Institute.
“I don’t have a bias that the peptides are bad, necessarily,” he added. “I just want to see the evidence, and we don’t have any.”
F.D.A. records show that the six committee members who sell peptides include self-described longevity physicians who market peptides for overall health, and even for some specific diseases. Some of their clinics also offer other unproven treatments such as ozone therapy and energy healing.
One member, Dr. Gabriel Alizaidy, is the scientific director at Maximus, a telehealth company that sells growth hormone peptides for about $200 per month. The company received a warning letter from the F.D.A. over its claims about compounded weight-loss medications.
Another panelist is Bobby Harshbarger, a Tennessee state senator and pharmacist. His mother, Representative Diana Harshbarger, Republican of Tennessee, who is also a pharmacist, wrote to Mr. Kennedy in November urging him to allow wider use of some of the peptides under consideration Thursday and Friday.
On a podcast last year with Gary Brecka, a biohacker who sells peptides on his website, Mr. Kennedy said the F.D.A. should “just do the science” on items like peptides and unproven stem cell treatments, “but not tell people, and not tell physicians, what they can and cannot prescribe.”
“If you want to take an experimental drug, you can do that,” Mr. Kennedy said. “You ought to be able to do that.”
More recently, Mr. Kennedy has said that the 2023 ban on the peptides has forced people to use gray-market peptides that present safety concerns. Adding them to the list of compounds that can be made in regulated pharmacies would increase safety, he has argued.
But Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding, said that traditional manufacturers of pharmaceutical ingredients had never made these peptides.
He said that would be unlikely to change if Mr. Kennedy reverses the ban, given widespread jitters among compounding pharmacies about using peptides that were “never authorized for use in human drugs.”
Mr. Brunner said he would propose at the hearing on Thursday that the peptides be added to the list of items that pharmacies can compound, but in a process that includes guardrails such as safety tracking, disclosures about risks and mandatory reporting of serious adverse events.
Doing so, he said, would mean “allowing state-licensed pharmacies to prepare the substances as a means of blunting the illicit markets.”
To prepare for the two-day meeting, F.D.A. scientists performed reviews of each of the seven peptides. One initial obstacle they discovered was that even though each peptide had a single name, in practice, it tended to refer to a mixed bag of formulations.
What patients actually get “may offer distinct properties,” the F.D.A. said in its analysis of one peptide, and “represent a safety risk for patients” who get a different substance than what a doctor had in mind.
Scientists also noted that some peptides marketed as longevity tonics may also promote cancerous tumor growth.
They also suggested that patients pursuing peptide therapy for serious conditions could miss out on treatments that were carefully reviewed and deemed effective. They flagged one small study of the peptide BPC-157 for people with ulcerative colitis that suggested benefits that the agency scientists found unconvincing for “a serious chronic disease that may cause life-threatening complications.”
Dr. Pinchas Cohen, the dean of the University of Southern California Leonard Davis School of Gerontology, is scheduled to present his research at the meeting but said he is “very conflicted” about the issue.
Dr. Cohen (no relation to Dr. Pieter Cohen) was the first to publish on one of the peptides being debated, MOTS-c. He thinks the peptide is safe and may be beneficial for muscle and metabolic health, but he would prefer to develop the molecule as a drug through the traditional pathway.
Still, he added, “Since tens of thousands of people want this and other peptides, to protect them, I think it will be beneficial to semi-legalize this process.”
