An FDA advisory committee voted Thursday to remove compounding restrictions on four peptides despite little evidence the products are safe or effective for medical use.
BPC-157 -- touted by wellness influencers and considered a doping substance by international sports authorities -- is being proposed as a treatment for ulcerative colitis; KPV is being proposed for inflammatory conditions and wound healing; TB-500 is being proposed for wound healing; and MOTS-c has been proposed for obesity, osteoporosis, and insulin resistance.
In a series of 8-6 votes (with one abstention), the panelists recommended that the free base and acetate forms of BPC-157, KPV, and TB-500 be placed on the agency's 503A bulk drugs compounding list, which allows pharmacies to make compounded versions. The panel also voted 7-5 (with two abstentions) in support of TB-500.
The votes came during a nearly 12-hour session, the first of a 2-day meeting of the agency's Pharmacy Compounding Advisory Committee, where more than half a dozen peptides are under review for conditions that also include opioid withdrawal, insomnia, narcolepsy, cerebral ischemia, migraine, and trigeminal neuralgia.
FDA staff has recommended against putting any of the peptides on the compounding list, noting that their chemical makeup "was not well characterized" and that few safety or efficacy studies support them for the proposed uses.
The committee itself was recently reconstituted by HHS Secretary Robert F. Kennedy Jr. New members include more than a half-dozen panelists who run clinics, online businesses, or pharmacies specializing in peptides, which are often given alongside other unapproved therapies, including vitamin infusions.
For example, panel member Haleem Mohammed, MD, MBA, who voted in favor of adding the peptides to the compounding list, runs clinics in Florida that sell injections of peptides, vitamins, testosterone, and weight-loss medications.
Since becoming the nation's top health official, Kennedy has vowed to overturn restrictions on the unproven products put in place during the Biden administration. Peptides of course also include legit pharmaceutical products such as the GLP-1 drug semaglutide (Ozempic, Wegovy) for diabetes and weight-loss, and the recently approved PCSK9 inhibitor enlicitide (Lipfendra) for lowering cholesterol.
Committee members were divided on whether putting the peptides on the list or keeping them off was better for patient safety.
Todd Durham, PhD, the consumer representative on the committee, voted against adding BPC-157 to the compounding list, saying there was "a lack of evidence for efficacy for ulcerative colitis, and at the very least some suggestion of potential harm should people be exposed to this substance over the long term."
"There are other available therapies for the proposed indication," added Durham, senior vice president for clinical and outcomes research at the Foundation Fighting Blindness, who said he worries what message the recommendation conveys about FDA approvals.
But Melissa Loseke, DO, chief medical officer of the Re-New Institute in Omaha, Nebraska, said she voted yes because putting peptides on the bulk drugs list would enable more restrictions to be put on them.
"I would like to see some tighter restrictions -- APIs [active pharmaceutical ingredients] from U.S.-based pharmacies only, patient registries, and mandatory side effects reporting," she said.
"Many years ago, I made a promise to do no harm to my patients, and probably two or three times a week, I'm trying to fix something that a chiropractor or a nutritionist did," said Loseke. "Just last week, I had a patient whose [peptide] that they brought to me was laced with MDMA and ecstasy. That's not protecting the American people."
Getting a place on the compounding list is not the same as being approved by the FDA, but the notion that adding peptides or other substances to the bulk drugs list could become an end run around the agency's approval process was a recurring theme at the meeting.
"We are at the risk of undermining the integrity of our entire FDA approval framework based on safety and effectiveness," said John Hertig, PharmD, of the Collaborative for Evidence-Based Medicine, during a public comment period.
"It really does put the entire public and patient safety system at risk," he said, noting that it could create a parallel pathway to get a product to the public with less rigor and fewer science-backed studies.
The agency doesn't have to heed the advice of its advisory committees, but it usually does.