An advisory committee to the Food and Drug Administration (FDA) voted narrowly to loosen restrictions on peptides, despite strong objections from the agency’s career scientists.
Throughout the daylong meeting, FDA scientists detailed the lack of evidence supporting the use of the peptides, as well as raising safety concerns.
Time and time again, the FDA returned to a fundamental sticking point: Chemically, it’s unclear what exactly these peptides are. In other words, there was no universally accepted chemical formula for each peptide, making it extremely difficult for the FDA to evaluate their use.
“We’ve never faced a problem like, ‘What is this?’” Russell Wesdyk, an FDA official, told the panel Thursday morning.
Peptides have gained widespread popularity in recent years, touted by both the wellness industry and high-profile figures, including Health Secretary Robert F. Kennedy Jr. and the podcaster Joe Rogan. These compounds are touted for a variety of uses, from anti-aging benefits to better sleep and faster recovery.
However, peptides have largely existed in a “gray market”: They are not FDA-approved drugs, but can often be purchased online from suppliers who label them “for investigational use only,” a legal way to avoid regulations to sell compounds that they claim are not intended for humans.
Allowing the formulation of peptides, Kennedy has argued, would steer people away from the gray market and toward safer products.
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This Thursday, the FDA’s Pharmaceutical Preparations Advisory Committee voted in favor of four peptides: BPC-157, KPV, TB-500 and MOTS-c. On Friday, the committee will look at emideltide, epitalon and semax.
Committee votes do not make peptides FDA-approved drugs. Instead, they recommend that peptides be added to a list of medications that compounding pharmacies can make. The final decision will be made by the FDA through a proposed rule.
Eight members of the panel were appointed by Kennedy, including six who run clinics offering peptides. One of the committee members, Tennessee state Sen. Bobby Harshbarger, is the son of Rep. Diana Harshbarger, R-Tenn., who last year wrote to Kennedy asking that compounders be allowed to make certain peptides.
In the case of the BPC-157, KPV and TB-500 peptides, all eight new members voted in favor. Six other members voted against and one person abstained. Regarding MOTS-c, seven of the new members voted in favor, five people voted against and two, including one of the new members, abstained.
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FDA scientists evaluated the peptides for specific uses: BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis.
However, during a public comment period prior to each peptide’s submission, proponents of the compounds presented what they claimed was additional data for other uses. That data was not always included in FDA scientists’ presentations, a decision that upset some committee members.
Wesdyk defended the process, saying scientists reviewed everything that was received before the deadline. “There is no attempt to hide anything or stop using anything,” he said, adding that the agency would continue to evaluate new data.
However, at various points throughout the day, FDA scientists noted that, simply, there was no data that they could evaluate in the case of certain peptides.
Dr. Haleem Mohammed, medical director of Gameday Men’s Health, a men’s health clinic in Florida that offers peptides, said he voted in favor of BPC-157 “for patient safety, the public good and medical freedom.”
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Earlier in the day, he mentioned his concerns about the gray market. “As a doctor, I have to make sure I keep patients as safe as possible,” he said. “So when I think about something like rejecting this and pushing it to the gray market, am I doing more harm? And that’s what keeps me up at night.”
David Pope, pharmaceutical director of Xifin Pharmacy Solutions in Georgia, said his vote in favor of BPC-157 was “to put this decision back in the hands of the patient, the doctor and the pharmacist.”
Dr. Brian Lee, an associate professor of medicine at the Keck School of Medicine of USC in Los Angeles, voted against it, arguing that the public could interpret the votes – and the FDA approval. as a product endorsement and that some of the compounds may be no better than a placebo.
“In terms of efficacy, we know that 30% of patients who receive placebo will report a subjective response or even an objective response,” Lee said.
Others questioned why they were being asked to evaluate peptides in the first place.
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“I am concerned that we are responding to market-driven demand rather than a decision based on sound science,” said Dr. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, referring to her vote against KPV.
“I’m also concerned about the argument that patients are getting it anyway,” Rebello noted after a later vote on TB-500. “In fact, that goes against the Hippocratic Oath, which says ‘do no harm,’ and if we don’t know if we’re causing harm, that’s a problem.”
