WASHINGTON (AP) — Health advisers met Thursday to review more than a half-dozen peptides, unproven substances that have become a growing wellness trend despite little evidence they are safe or effective.
In the first of several votes, the panel of Food and Drug Administration experts narrowly voted 8-6 in favor of broadening access to a chemical called BPC-157, one of the most popular peptides among longevity and wellness influencers. One panel member
abstained from voting.
The two-day meeting has the backing of Health Secretary Robert F. Kennedy Jr., who has described himself as a “big fan” of peptides and vowed to overturn FDA restrictions put in place under President Joe Biden.
The vote on BPC-157 reflected the unusual makeup of the panel. Before the meeting, more than a half-dozen people with connections to the peptide industry were added to the panel, including doctors, pharmacists or consultants who work with the chemicals.
All those experts voted in favor of allowing specialty pharmacies to produce their own formulations of BPC-157 for patients.
“I voted yes because it’s time to put this decision back in the hands of the patient, the physician and the pharmacist,” said David Pope, chief pharmacy officer of Xifin Pharmacy Solutions.
The vote came despite a highly critical review of the peptide from FDA’s staff scientists, who said there was little data suggesting BPC-157 is effective for medical use.
The panel is scheduled to take similar votes Thursday and Friday on six other popular peptides, recommending whether they should be added to a list of substances that are safe for compounding by pharmacies. The votes aren’t binding and the FDA has periodically bucked the recommendations of its outside experts.
In recent years, the FDA has warned Americans about the risks of injecting peptides like BPC-157 and TB-500, another compound set for review Thursday. Both are considered doping substances by international sports authorities.
Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.
FDA convened this week’s meeting to discuss seven unapproved peptides that are under review for various medical conditions, including ulcerative colitis, migraines and opioid addiction. FDA’s staff reviewers said before the meeting they couldn’t find strong evidence to support any of those uses.
Social media platforms are brimming with testimonials from people claiming the substances helped them build muscle, recover from injuries or look younger. BPC-157 is among the most popular peptides sold online and via compounding pharmacies. It’s been cited by podcaster Joe Rogan and other celebrities as a way to heal injuries.
But FDA scientists said they could find little data on the medical use of BPC-157 and raised concerns about risks of contamination, allergic reactions and quality control.
Five studies of BPC-157 reviewed by the agency “were of short duration, had small sample sizes and evaluated doses that were likely exploratory in nature,” the staffers said.
Even determining which form of the drug should be used was unclear to regulators, since BPC-157 is not recognized as an official pharmaceutical ingredient in the U.S.
“There’s no way to know what the substance actually is, was or will be tomorrow because that name has no legal meaning,” said Russell Wesdyk, an associate director in FDA’s drug center,
The panel votes are only one part of more than 18 hours of discussions and presentations scheduled across the two days.
During a public comment period, the panel heard from more than 20 speakers — including doctors, lawyers and peptide entrepreneurs — urging that BPC-157 and other substances be made more widely available.
Brigham Buhler, a wellness clinic owner whose clients include Rogan and other celebrities, said allowing U.S. pharmacies to compound peptides would steer Americans away from unvetted products imported from China and other foreign countries.
“It’s crucial to allow patients to have safe and effective access to these treatment options,” Buhler said. “Individuals who have gotten these resources are going to continue to utilize these products.”
After the meeting, the FDA will review the votes, discussion and public comments before making a decision on each of the peptides.
FDA-watchers say the most likely outcome may be a temporary policy reassuring pharmacies that they won’t be targeted for compounding the peptides under review. Formally placing the substances on FDA's list of drugs that are safe for compounding would require new regulations, which can take months or years to draft.
“We’re still going through this process, but I think it’s more than likely that the process will end up at the result that Secretary Kennedy wants,” said Nathan Beaver, an attorney specializing in FDA issues.
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