FDA panel votes to support compounding of six peptide therapies

Panel recommendation does not change legality; FDA must still review data

A committee that advises the Food and Drug Administration voted in late July to allow compounding pharmacies to produce six of seven unapproved peptide injectables, but the vote does not itself change the legal status of the substances. The agency’s leadership must now weigh the evidence and determine whether to formally authorize the production of BPC-157, TB-500, MOTS-c, and the other compounds, a process that could take several months to more than a year — though the administration may attempt to accelerate it.

The hearing drew unprecedented attention to the experimental therapies. The panel considered seven peptides in total — all promoted widely in wellness and longevity circles for injury recovery, muscle growth, fat loss, and metabolic enhancement — and voted in favor of all but one. Patients who followed the debate are now asking when the drugs might become available through legitimate channels, according to Dr. Jessica Duncan, chief medical officer of the telehealth company IVIM Health, who spoke in favor of the peptides at the meeting.

“They are now even more curious,” Duncan said. “We tell them that the timeline is uncertain.”

Normally, the FDA would move forward through its formal rulemaking process, which could take from several months to more than a year, said Jesse Dresser, a partner at the law firm Frier Levitt who represents compounding pharmacies. But Dresser told NPR that the circumstances are unusual. “It would actually surprise me if this followed the traditional pathway of formal rulemaking,” he said. “Whatever options exist to make this a faster process, I think they are going to be leveraged.”

One likely scenario, Dresser said, is that the agency places the peptides on the “Category One list” in the interim, giving compounding pharmacies legal cover to begin manufacturing them while the longer rulemaking proceeds. Another, more legally contentious path would see Health Secretary Robert F. Kennedy Jr. cite the dangers of the unregulated peptide market as justification to immediately authorize compounding — a power normally reserved for removing unsafe products. Dresser called the situation “a unique scenario, unique product, unique industry and unique administration.”

If the FDA instead decides to reject the panel’s recommendation, it would likely face lawsuits from industry, according to Abha Kundi, an attorney at the firm Aaron Fox Schiff who focuses on FDA regulatory law. Kundi said the agency is “very attuned” to the reality that the peptides are already widely accessible online. “In many ways, the toothpaste is out of the tube here,” she said. “I think that is absolutely part of the calculus.”

That reality is the gray market that expanded after the FDA several years ago barred compounding pharmacies from making many of the substances, citing safety concerns. The shift led to a situation in which people obtain the peptides from unvetted online sources under the guise that they are used for “research purposes,” not human consumption.

“The gray market space is a lot seedier than what people think,” said Dr. Haleem Mohammed, chief medical officer of Gameday Men’s Health and one of the FDA panelists who voted to support the peptides. “This is about moving towards a regulated pathway for peptides that patients are already using.”

FDA career scientists had recommended against altering the regulatory status of any of the seven peptides, pointing to a lack of published human data and noting that even defining the substances was difficult because a single common name can refer to many chemically different compounds. None of the seven has undergone the large-scale, rigorous human trials required for full drug approval.

Ilisa Bernstein, a former FDA official and pharmacist who is an expert on drug and pharmacy policy, said the agency has a “responsibility to ensure that there’s some level of safety before they become widely available.” She noted that once the door is opened, any pharmacy can compound the products, which “could have a huge presence in the marketplace.”

Even if the FDA ultimately permits compounding, patients will not be able to obtain the drugs at a corner pharmacy soon. The drugs would be prepared only by compounding pharmacies, and Scott Brunner, who leads the industry trade group the Alliance for Pharmacy Compounding, said pharmacies will need time to acquire the active ingredients. “It’s going to create some chaos,” Brunner said. “It might take two months, it might take nine months, it depends on the substance.”

Meanwhile, prescribing practices are likely to be uneven. Major direct-to-consumer telehealth companies and longevity clinics already market the peptides, but many doctors in conventional medical settings are expected to remain cautious because no widely accepted, evidence-based guidelines from major medical associations yet exist. Dr. Harmeet Narula, an endocrinologist at Banner Health in Arizona who regularly fields patient questions about the therapies, said “the commercial enthusiasm is outpacing clinical science” and stressed that the advisory committee’s vote “does not mean these drugs are FDA approved.”

The advisory committee’s vote followed a two-day review of the seven peptides that began on July 23, as MSI previously reported.