The Food and Drug Administration’s advisory committee narrowly voted to ease restrictions on the peptide, over strong opposition from career agency scientists.
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Throughout the day-long meeting, FDA scientists detailed the lack of evidence supporting the use of peptides, as well as safety concerns.
The FDA returned to the big sticking point again and again. That said, it’s not even known what these peptides are chemically. In other words, each peptide did not have a universally accepted chemical formula, making it extremely difficult for the FDA to evaluate its use.
“We’ve never had the question of, ‘What is it?'” FDA official Russell Wesdyk said during a panel discussion Thursday morning.
Peptides have skyrocketed in popularity in recent years, touted not only by the wellness industry but also by celebrities such as Secretary of Health Robert F. Kennedy Jr. and podcaster Joe Rogan. These compounds are touted for a variety of uses, from anti-aging effects to improving sleep and promoting healing.
However, these peptides primarily exist on the “grey market,” meaning they are not FDA-approved drugs, but are often purchased online from vendors who label them as “for research use only,” a legal workaround for selling compounds that claim they are not for human use. Kennedy argued that allowing the synthesis of peptides would encourage people to stay away from the gray market and seek 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 consider Emidertide, Epitalon and Semax.
The committee’s vote does not make the peptide an FDA-approved drug. Instead, they recommend adding peptides to the list of medicines that compounding pharmacies are allowed to manufacture. The final decision will come from FDA in the form of a proposed rule.
Eight panel members were appointed under the Kennedy administration, six of whom run clinics offering peptides. One of the committee members, Tennessee Sen. Bobby Hershberger, is the son of Rep. Diana Hershberger (R-Tenn.), who wrote a letter to Kennedy last year asking him to allow compounders to make certain peptides.
All eight newly appointed members voted in favor of peptides BPC-157, KPV, and TB-500. A further six committee members voted against the motion and one abstained. In MOTS-c, seven of the new appointees voted in favor, five voted against, and two abstained, including one of the new appointees.
FDA scientists considered 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 the public comment period that preceded each peptide’s publication, proponents of the compounds provided what they claimed was additional data for other uses. That data was not always included in FDA scientists’ presentations, a decision that frustrated some committee members.
Wesdyk defended the process, saying the scientists considered everything submitted by the deadline. “There is no attempt to hide anything or not use anything,” he said, adding that the agency would continue to evaluate new data.
But several times throughout the day, FDA scientists said that no data existed to evaluate certain peptides.
In a discussion about KPV, Josh Mailman, chairman of the board of the Neuroendocrine Tumor Research Foundation, said, “You’re voting on something here, but you don’t know what it is. It’s like a black box to me.” Postmen voted against it.
The lack of data did not necessarily deter committee members from recommending the peptide. Dr. Gabriel Alizaidi, a clinical researcher at Maximus, an online clinic that offers peptides, said he voted in favor of BPC-157 because he was “frankly disappointed that the data were so incomplete.”
The yes vote sometimes reflected common talking points with President Kennedy.
Dr. Haleem Mohamed, chief medical officer at Gameday Men’s Health, a Florida men’s clinic that offers peptides, said he voted in favor of 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 doctor, I have to keep my patients as safe as possible,” Mohammed said. “So am I doing more harm by saying no to this and looking at things that push it out onto the gray market? And that’s what keeps me up at night.”
David Pope, chief pharmacy officer at Xifin Pharmacy Solutions in Georgia, said the yes vote on BPC-157 was “to put this decision back in the hands of patients, doctors, and pharmacists.”
Dr. Brian Lee, an associate professor at the Keck School of Medicine at the University of Southern California in Los Angeles, voted against it, arguing that the public could view the vote and the FDA’s approval as an endorsement of the product, and that some compounds may be no different from a placebo.
“In terms of efficacy, we know that 30% of patients who receive a placebo have a self-reported or objective response,” Lee said.
Some people questioned why they were being asked to review peptides in the first place.
Dr. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, said of her vote against KPV, “I am concerned that we are responding to market-driven demand rather than a decision based on solid science.”
“I’m also concerned about the argument that patients are getting infected anyway,” Rebelo said after the subsequent vote on TB-500. “This actually violates the Hippocratic Oath, which is to do no harm, and if you don’t know if you’re causing harm, that’s a problem.”
