FDA advisory panel votes to lift restrictions on four peptides amid safety concerns

An advisory panel convened by the Food and Drug Administration voted Thursday to recommend lifting manufacturing restrictions on four peptide substances intended for human use. The panel, which was sharply divided, approved the recommendation for the four peptides, with votes on three additional peptides scheduled for the following day. The decision was made despite a continued lack of human safety and efficacy data for the compounds.

The panel’s composition was changed earlier in the year after Health and Human Services Secretary Robert F. Kennedy Jr. added new members, most of whom have commercial interests in peptide manufacturing. According to reporting, the pre-existing members voted against the recommendation, while the newly appointed members provided the decisive votes.

Kennedy has advocated for reversing a previous ban that prevented compounding pharmacies from producing certain peptides. He has stated that “independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence,” although no such evidence was presented at the meeting.

The advisory panel’s recommendation is non-binding; the FDA could choose to reject it. An FDA official told a committee member that the agency has never approved a product that had not been tested in humans, a factor that may influence the agency’s next steps.

The outcome raises questions about the adequacy of the review process for peptide drugs that have not undergone comprehensive clinical testing.