FDA panel narrowly backs unapproved peptide drugs favored by RFK Jr. and wellness influencers

WASHINGTON (AP) — A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals haven’t been shown to be safe or effective.

In a series of votes, outside experts to the Food and Drug Administration advised the agency to drop current restrictions barring pharmacies from producing injectable peptides with names including BPC-157, TB-500 and KPV.

The panel’s vote is not binding but is likely to embolden 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.

Across several votes, the panelists voted 8-6, with one abstention, in favor of putting the peptides on FDA’s list of substances considered safe for pharmacy compounding. If FDA follows that advice, telehealth companies are expected to ramp up marketing of the chemicals for wellness and cosmetic uses.

Thursday’s vote tally reflected the unusual makeup of the panel. Prior to the meeting, more than a half-dozen people with connections to the peptide industry were added to the group, including doctors, pharmacists or consultants who work in the field.

“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, after the vote on BPC-157.

The panel will vote Friday on three more peptides. The FDA isn’t required to follow the group’s advice, though it usually does.

FDA scientists remain unconvinced of peptide safety and benefits

The positive votes came despite highly critical reviews from FDA staff scientists, who said there was little data that BPC-157, TB-500 and the other chemicals can be safely used for medical purposes.

Panel members with backgrounds in academia, rather than peptides, mostly voted against the substances, which are widely advertised on social media.

“I’m concerned we’re responding to a market-induced demand rather than a decision based in solid science,” said Dr. Elizabeth Rebello of the University of Texas MD Anderson Center.

Peptide supporters include podcaster Joe Rogan and longevity influencers such as Gary Brecka, a supporter of Kennedy’s “Make America Healthy Again” agenda who sells peptides through his website.

But medical experts describe the marketplace as a “Wild West” of unproven, unregulated drugs that could cause serious harm, including infection, allergic reactions or other problems.

“This is really alarming,” said Rita Jew, a pharmacist and president of the Institute for Safe Medication Practices, in an interview ahead of the meeting. “There aren’t that many other substances people are injecting into themselves where you see that the clinical evidence is so lacking.”

In recent years, the FDA has warned Americans about the risks of injecting peptides like BPC-157 and TB-500. In 2023, both were placed on a list of substances considered to be too high-risk for pharmacy compounding. But Kennedy announced their removal from that list earlier this year.

Gap between FDA-approved drugs and wellness peptides is wide

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.

But most peptides sold online are promoted for unproven uses, often combined in “stacks,” to purportedly heal injuries, build muscle, rejuvenate skin or increase energy.

FDA scientists said they could find little data on the effectiveness of peptides for proposed medical uses like ulcerative colitis, wound healing and opioid addiction.

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.

For TB-500, regulators said they could not find any human studies using the compound.

Even determining which form of the peptides should be used was unclear to regulators, since substances like TB-500 aren’t recognized as official pharmaceutical ingredients 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.

Peptide supporters push for easier access

The panel votes are only one part of more than 18 hours of discussions and presentations scheduled across two days.

During several public comment periods, the panel heard from more than two dozen speakers — including doctors, lawyers and peptide entrepreneurs — urging that the 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.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.