Key facts
- An advisory committee selected by Robert F. Kennedy Jr. voted to overturn a ban on the manufacture of unapproved peptides.
- The committee's decision was made despite a lack of safety and efficacy data for the peptides.
- The FDA has not previously approved any substance that has not been tested in humans.
- The committee's role is advisory, and the FDA can reject its recommendations.
An advisory committee hand-picked by Robert F. Kennedy Jr. has voted to overturn a ban on the manufacture of unapproved peptides, a decision that occurred despite a lack of safety and efficacy data for the substances. The committee's vote was decisive, with the newly appointed members providing the necessary support, while pre-Kennedy members voted against the measure.
While the FDA has approved peptide drugs like insulin and certain weight-loss medications through standard processes, most peptides remain off the market due to insufficient safety and efficacy data. The Biden administration had previously blocked their manufacture by compounding pharmacies. However, Kennedy expressed interest earlier this year in reversing this ban.
Concerns were raised that Kennedy would stack the advisory board with allies who would predetermine decisions to ease access to these drugs without rigorous scientific evaluation. This prediction appeared to materialize when Kennedy added members in June who, with one exception, had clear interests in the manufacture and sale of the unapproved peptides.