FDA advisers recommend against the first unapproved peptide on second day of meeting

Several panelists on Thursday raised questions about whether the regulator would require compounders to submit safety data after adding the peptides to the list. 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. Because compounded drugs are not FDA-approved drugs, the statutory requirement for substantial evidence of effectiveness is not applied to these products, said Mary Thanh Hai, director at the Office of New Drugs, in her opening remarks on Friday. "That said, for any physician prescribing a compounded product, one would think that it's important that the question is asked; wouldn't we want to know if the drug works?" 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. In a narrow majority, members on the first day voted in favor of allowing unapproved peptides BPC-157, KPV, TB-500 and MOTs-c to be compounded by pharmacies for patients with a prescription. There have been 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. Outside advisers to the U.S. Food and Drug Administration on Friday recommended against allowing compounding pharmacies to make an unapproved sleep-inducing peptide, following votes a day earlier to recommend that they be allowed to make four unapproved compounds. Emideltide is the first of three under review on the second day of a closely watched meeting. The panel will also vote on semax and epitalon. The nearly 12-hour meeting on Thursday pitted FDA staff, who argued against broader pharmacy compounding of the seven peptides under review due to limited evidence of safety and efficacy, against several panel members, many of whom have ties to the peptide industry and could benefit from expanded access. FDA staff argued on Friday that emideltide should remain off a list that allows U.S. companies to manufacture the drugs, saying there is no safety data to justify loosening its restrictions. Seven members voted to maintain restrictions for manufacturing the unapproved peptide emideltide. Six of the members voted in favor, while one member abstained. "I voted 'no,' primarily for low quality evidence around efficacy, the poor characterization of the bulk drug substance, and the fact that there are approved medical therapies for all the proposed uses," said Todd Durham, a panel member and a senior vice president at Foundation Fighting Blindness. The panel's support on Thursday for the peptides, drugs built from the same building blocks the body uses to make proteins, marks a victory for Health Secretary Robert F. Kennedy Jr., a vocal advocate, as well as for the biohackers, wellness influencers and online communities that have championed their use. These unapproved versions of 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. Some public commenters urged the advisers to vote in favor of loosening restrictions, in order to discourage illegal sourcing by making the ingredients readily available in the U.S. 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 U.S. Food and Drug Administration will ultimately decide whether to allow broader access.

FDA advisers recommend against the first unapproved peptide on second day of meeting

Questions remain over safety data and guardrails

FDA advisers reject emideltide on second day of peptide review

Broader peptide access could benefit wellness and telehealth sectors

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