Outside advisers to the Food and Drug Administration (FDA) resumed their assessment of three additional peptides on Friday during the second day of a closely watched meeting, extending discussions that began a day earlier. The advisory panel had recommended that compounding pharmacies be permitted to produce four unapproved peptide compounds.
The meeting, which lasted nearly 12 hours, featured differing viewpoints between FDA staff and several members of the advisory panel. FDA officials argued against expanding pharmacy compounding of the seven peptides under review, citing limited evidence regarding their safety and efficacy. In contrast, several panel members—many of whom have ties to the peptide industry and could potentially benefit from wider availability—supported broader access.
The panel’s endorsement of these peptides, which are built from the same building blocks the body uses to make proteins, represents a significant development for Health Secretary Robert F. Kennedy Jr., who has publicly supported peptide use, as well as for biohackers, wellness influencers and online communities that have actively promoted them.
Although unapproved versions of these peptides are already widely sold online through unregulated gray-market channels for purposes ranging from muscle recovery to longevity, analysts estimate that a legitimized peptide market could be worth between $2 billion and $3 billion, creating major opportunities for the telehealth industry.
FDA Staff and Panel Debate Safety, Quality, and Oversight
During Thursday’s discussions, several panelists questioned whether compounders would be required to submit safety data if the peptides were added to the list permitting pharmacy compounding for patients with a prescription. FDA staff responded that the panel itself does not have the authority to direct the regulator and indicated that the FDA’s investigational new drug application pathway would instead serve as the mechanism for monitoring safety of the peptide compounds.
Addressing the panel on Friday, Mary Thanh Hai, director at the Office of New Drugs, emphasized the distinction between compounded products and FDA-approved medicines. “Because compounded drugs are not FDA-approved drugs, the statutory requirement for substantial evidence of effectiveness is not applied to these products,” she said in her opening remarks.
“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,” she added.
Concerns also extended beyond safety to the quality standards and common naming conventions associated with peptide compounds. Both panel members and participants from the public highlighted the need for clearer regulatory safeguards during Thursday’s proceedings.
On Friday, FDA staffer Russell Wesdyk addressed those issues directly, stating, “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.”
On the first day of the meeting, panel members narrowly voted in favor of allowing the unapproved peptides BPC-157, KPV, TB-500 and MOTs-C to be compounded by pharmacies for patients with a prescription. The discussions have also drawn attention to concerns over potential bias because of several panelists’ affiliations with the peptide industry. However, the health department has stated that all members underwent the same ethics review and vetting process required of FDA advisory committee members before participating in the proceedings.
