July 24 (Reuters) – Outside advisers to the U.S. regulator on Friday began their review of three more peptides on the second day of a closely watched meeting, following their recommendation a day earlier that compounding pharmacies be allowed to make four unapproved compounds.
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.
The panel’s support 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.
On Friday, they will vote on emideltide, semax and epitalon.
The telehealth industry stands to reap a significant windfall, as a legitimized peptide market could be potentially 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.
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Several panelists on Thursday raised questions on whether the regulator would require compounders to submit safety data after adding the peptides to the list that would allow them to be compounded by pharmacies for patients with a prescription.
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.
(Reporting by Sriparna Roy and Sneha S K in Bengaluru; Editing by Shinjini Ganguli)
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