Outside advisers to the U.S. Food and Drug Administration reconvened on Friday to continue reviewing a slate of peptide products, taking up three more items after a high-profile opening day the previous day. The second-day agenda centers on a trio of peptides the panel will vote on: emideltide, semax and epitalon.
The first day of the meeting produced a notable outcome when the advisory group recommended on Thursday that compounding pharmacies be permitted to produce four unapproved compounds. That initial session stretched nearly 12 hours and exposed clear divisions between FDA staff and multiple members of the advisory panel.
FDA staff presented a cautionary view to the committee, arguing against expanding pharmacy compounding for the seven peptides under review. Agency staff cited what they described as limited evidence on both safety and efficacy for those compounds.
Several panel members, however, expressed a different perspective. The record shows some advisers have ties to the peptide industry and stand to gain from broader access, a point the meeting highlighted during the debates. The panel’s evolving position has political resonance as well: its support for certain peptides was described as a favorable outcome for Health Secretary Robert F. Kennedy Jr., who has publicly voiced support for the substances.
The positions taken by the panel also align with groups and communities outside formal clinical channels. Biohackers, wellness influencers and online forums that have promoted peptide use stand to see their advocacy reflected in the panel’s recommendations.
At a basic level, peptides are compounds constructed from the same molecular building blocks the body uses to assemble proteins. Versions of these peptides that are not approved by regulators are already circulating online through unregulated channels in the gray market, where they are marketed for uses ranging from muscle recovery to longevity.
With additional hearings scheduled, Friday’s votes on emideltide, semax and epitalon will add to the committee’s record and shape the immediate debate over whether compounding pharmacies should gain wider latitude to prepare these unapproved peptide formulations.
Summary
An FDA advisory committee continued its review on Friday of three peptides after a contentious opening day. The first day saw the panel endorse permitting compounding pharmacies to prepare four unapproved compounds, while agency staff warned against broader compounding of seven peptides due to limited safety and efficacy evidence. Friday’s agenda includes votes on emideltide, semax and epitalon.