FDA scientists warn of insufficient evidence as panel to review peptide therapies
FDA reviewers have raised safety and efficacy concerns about several peptide drugs slated for consideration by an advisory panel, while Health Secretary Robert F. Kennedy Jr. advocates loosening restrictions.
The Food and Drug Administration released a review on Monday highlighting a lack of robust clinical evidence and potential safety issues for a group of peptide therapies that a federal advisory panel will evaluate in late July. The peptides under review, including BPC-157, TB-500 and MOTS-C, are marketed online for purported benefits such as injury recovery, muscle repair and metabolic effects, but have not been tested in large, controlled human trials.
The FDA scientists noted inconsistent data and flagged possible risks, echoing findings from prior assessments of these compounds. The Biden administration had reclassified the peptides in 2023, effectively restricting compounding pharmacies from producing them, which pushed some users toward unregulated sources abroad.
Health Secretary Robert F. Kennedy Jr. has publicly expressed personal use of the peptides and urged the FDA to permit compounding pharmacies to resume offering them. The upcoming panel, composed of members with industry ties, will examine evidence for seven peptides across indications such as ulcerative colitis, wound healing, obesity and migraines during a two-day meeting on July 23-24, with a follow-up session planned for February.
It remains uncertain how the panel will balance the FDA scientists’ conclusions with industry perspectives when forming recommendations.