A Food and Drug Administration advisory committee narrowly voted in favor of loosening restrictions on peptides over strong objections from agency career scientists.
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Throughout the daylong meeting, FDA scientists detailed a lack of evidence supporting the use of the peptides along with safety concerns.
Over and over again, the FDA came back to a major sticking point: It’s unclear, chemically, what these peptides even are. In other words, there was no universally accepted chemical formula for each peptide, making it extremely difficult for the FDA to evaluate its use.
“We’ve never faced a problem of, ‘What is it?’” Russell Wesdyk, an FDA official, told the panel Thursday morning.
Peptides have surged in popularity in recent years, touted by the wellness industry as well as high-profile figures including Health Secretary Robert F. Kennedy Jr. and podcaster Joe Rogan. The compounds are promoted for a variety of uses, from anti-aging benefits to better sleep and faster healing.
However, the peptides have largely existed in a “gray market” — they are not FDA-approved drugs but are often bought online from vendors who label them “for research use only,” a legal workaround to sell compounds they claim aren’t meant for humans. Allowing the peptides to be compounded, Kennedy has argued, would move people away from the gray market and toward safer products.
On Thursday, the FDA’s Pharmacy Compounding 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.
The committee’s votes do not make the peptides FDA-approved drugs. Instead, they are recommending that the peptides be added to a list of drugs that compounding pharmacies are allowed to make. The final decision will come from the FDA in the form of a rule proposal.
Eight panel members were appointed under Kennedy, including six who run clinics that offer peptides. One committee member, 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.
For the peptides BPC-157, KPV and TB-500, all eight of the new appointees voted yes. Another six members voted no, and one person abstained. For MOTS-c, seven of the new appointees voted yes, five people voted no and two, including one of the new appointees, abstained.
The FDA scientists reviewed 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.
But during a public comment period ahead of each peptide presentation, proponents of the compounds offered what they said was additional data for other uses. That data wasn’t always included in the FDA scientists’ presentations — a decision that rankled some committee members.
Wesdyk defended the process, saying scientists reviewed everything that came in by the deadline. “There’s no attempt to conceal anything or not use something,” he said, adding that the agency would continue to evaluate new data.
But at several points throughout the day, the FDA scientists said that there was simply no data for them to assess for certain peptides.
During a discussion about KPV, Josh Mailman, president of the Neuroendocrine Tumor Research Foundation board of directors, said, “I’m voting on something here, but I don’t know what that something is. It’s kind of like a black box to me.” Mailman voted no.
A lack of data didn’t necessarily dissuade committee members from recommending the peptides. Dr. Gabriel Alizaidy, a clinical researcher at online clinic Maximus, which offers peptides, said he voted in favor of BPC-157 because he was “frankly disappointed at how incomplete the data was.”
Yes votes sometimes echoed common Kennedy talking points.
Dr. Haleem Mohammed, the chief medical officer at Gameday Men’s Health, a men’s health clinic in Florida that offers peptides, said he voted yes for BPC-157 “for patient safety, you know, the greater good and medical freedom.”
Earlier in the day, he cited concerns about the gray market. “As a physician, I have to make sure that I’m keeping patients as safe as possible,” Mohammed said. “So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? And that’s what I lose sleep at night over.”
David Pope, the chief pharmacy officer at Xifin Pharmacy Solutions in Georgia, said his yes vote for BPC-157 was “to put this decision back into the hands of the patient, the physician and the pharmacist.”
Dr. Brian Lee, an associate professor of medicine at Keck School of Medicine of USC in Los Angeles, voted no, arguing that the public could view the votes — and FDA sign-off — as endorsements of the products and that some of the compounds may be no better than a placebo.
“For effectiveness, we know that 30% of patients on placebo will have a self-reported response or even objective response,” Lee said.
Others questioned why they were being asked to review the peptides at all.
“I’m concerned that we’re responding to a market-induced demand rather than a decision based on solid science,” Dr. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, said about her no vote on KPV.
“I’m also concerned with the argument that patients are getting it anyway,” Rebello said after a later vote on TB-500. “That actually goes against the Hippocratic oath, which is do no harm and if we don’t know if we’re causing harm, that’s an issue.”
