Here’s what to know.
Why is an FDA committee meeting about peptides?
The FDA convened the committee meeting on July 23 and 24 to debate whether to recommend that seven popular peptides be included on a list, called the 503A bulks list, that would allow compounding pharmacies to dispense them. Many of the voting members on the committee consult with or are employed by companies that could promote or dispense peptides. Usually, these FDA panels are composed of academics and researchers.
But it is unprecedented for a drug to be put on the pathway to widespread adoption in this manner instead of having to go through the more arduous and evidence-based FDA drug approval process, experts say. Most drugs are not dispensed through compounding pharmacies at all but are instead approved by the FDA and manufactured by drug companies under strict FDA supervision.
Since that 2023 ban, consumers have turned to alternative sources—including suppliers in China—which puts them in danger, advocates for peptides say. In testimony on July 23, Dr. Anant Vinjamoori, chief medical officer at the telehealth company Hims & Hers, said that a colleague had recently sent him a photo of a bodega in Queens selling peptides. “This is the real alternative to FDA's permission of legitimate pharmacies to compound peptides in controlled conditions,” he said. (Both Hims & Hers and Noom, a weight-management company, advocated before the vote for peptides to be allowed to be made at compounding pharmacies.)
What did the committee decide?
On BP-157, eight members of the committee voted yes, six voted no, and one abstained. The “yes” votes were largely from committee members who represent or advise telehealth companies, which broadly stand to benefit financially from the widespread adoption of peptides. Many of the people who voted “yes” said they wanted compounding pharmacies to dispense peptides because the alternative—patients getting the drug in the gray market—was worse.
Mohammed went on to vote “yes,” recommending that BP-157 be placed on the 503A bulks list. (He also voted “yes” on KPV.) He later said that he voted “yes” in part for “medical freedom.” That term was echoed by the American Academy of Peptide Medicine, an industry group that has been lobbying for the inclusion of peptides on the list; its founder later said in a statement that the committee “voted to restore medical freedom and medical liberty for all of us.”
In preparatory documents for the meeting, FDA staff said that it believed the evaluation criteria “weigh against” placing BPC-157 on the list because there was limited evidence about the peptide’s effectiveness and because there are other FDA-approved treatments for ulcerative colitis. The only trial FDA staff were able to find about the effectiveness of using BPC-157 to treat ulcerative colitis was a meeting abstract reporting on the results of a study using 46 people in which the peptide was given as an enema, not as an injection.
“I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science,” said committee member Dr. Elizabeth Rebello, executive director of anesthesiology, critical care, and pain medicine at the University of Texas MD Anderson Cancer Center.
“The substance's supposed benefits are largely based on anecdotal evidence, and the interest in it appears to be driven by those who stand to benefit from increased demand,” said Nina Zeldes, a researcher at Public Citizen's Health Research Group, a nonprofit watchdog group, in testimony on the morning of July 23 opposing the inclusion of BP-157.
What might this mean for peptides in the U.S.?
“As a consumer representative, I worry what placing a bulk substance on the list conveys in terms of FDA approval,” said committee member Todd Durham, senior vice president of clinical outcomes and research at the Foundation Fighting Blindness, who voted “no” on adding these peptides to the list.
Safdar says he knows of several instances when people had serious health problems after taking compounded medications. He worries that people will think that these peptides have robust clinical evidence behind them as a result of being added to the list.
Indeed, Lurie continued, financial analysts are predicting a $2.2 billion telehealth marketing opportunity if these seven peptides are approved for compounding. Him & Hers stock rose more than 10% after the BPC-157 vote.
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