FDA advisers recommend relaxing US rules on compounding peptides

Outside advisers to the U.S. Food and Drug Administration recommended broader access to six unapproved peptides, capping a two-day review that backed most of the compounds despite the health regulator's staff concerns about limited safety and effectiveness data. Over the course of the meeting held on Thursday and Friday, the panel voted to recommend the FDA allow compounding pharmacies to manufacture six out of seven peptides being considered for patients with a prescription, reversing Biden-era restrictions criticized by Health Secretary Robert F. Kennedy Jr. This was against the guidance of FDA staff, who argued there is not sufficient evidence to support loosening the rules on compounding. The FDA's staff said it does not have the authority to direct the regulator, and suggested that the FDA's investigational new drug application pathway would monitor the safety of the peptides. Some panel members and other public members also raised concerns over the quality standards on peptides, as well as the common names for them on Thursday. "We lack the regulatory authority that put those guardrails in place ... Even before I can get to putting quality guardrails in place, we've got to establish an identity. So that's what I'd ask you to think about as we go through these votes today," FDA staffer Russell Wesdyk told the panel on Friday. On Friday, a narrow majority asked the agency to allow compounding of the unapproved peptides Epitalon and Semax, used to support aging and treat migraines, respectively, after recommending on Thursday that pharmacies be permitted to make four other unapproved compounds. The panel's support for the treatments marks a victory for Health Secretary Robert F. Kennedy Jr., who has said he has used peptides and in April described a black market of unregulated products that still make their way into the United States. The Biden administration in 2023 found that nearly 20 peptides raised safety concerns and barred their legal compounding. Advisers on Friday voted against allowing compounding pharmacies to make an unapproved sleep-inducing peptide, emideltide. The 14-member committee prior to the meeting added seven people who operate or work for clinics or businesses selling peptide treatments. Critics have raised concerns about the bias of the panelists given their affiliation to the peptide industry, although the health department has said the members underwent the same ethics review and a vetting process required of all FDA advisory committee members. Peptides are already widely available online through unregulated channels in the gray market where the substances are sold for everything from muscle recovery to longevity. "We didn't approve a drug. Nobody put a finished product on a shelf. We took a decision that patients are already making, and we try to keep it inside a system that has rules and regulations," said Haleem Mohammed, a voting member and the chief medical officer at Gameday Health, a men's health clinic. The telehealth industry stands to reap a significant windfall, as a legitimized peptide market could be valued at $2 billion to $3 billion, analysts estimate. The panel's recommendations are, however, non-binding, and the FDA will ultimately decide whether to allow broader access.

FDA advisers recommend relaxing US rules on compounding peptides

FDA advisers back broader access to six peptides

FDA staff warn about guardrails and quality standards

Epitalon and Semax get support, emideltide is rejected

Telehealth industry could benefit if FDA broadens access

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