RFK Jr.'s hand-picked committee approves manufacture of peptides he uses - Ars Technica

What the report says

Ars Technica reported that an FDA-organized advisory committee voted Thursday to recommend easing restrictions on the manufacture of certain peptides for human use. The divided panel backed lifting limits on four peptides, with votes on three more expected the following day. The article says the recommendation came even though no human safety or efficacy evidence was presented for the substances under review.

Peptides are short chains of amino acids, and some are well-established medicines when developed through the FDA’s normal approval process, such as insulin and newer weight-loss drugs. Ars noted that many other peptides have not cleared that process, and that the Biden administration had restricted their production by compounding pharmacies, which make customized medications. The committee’s recommendation would move toward reversing those limits.

According to Ars, Health and Human Services Secretary Robert F. Kennedy Jr., described as a supporter and user of peptides, had signaled earlier this year that he wanted to revisit the restrictions. The outlet reported that Kennedy added members to the advisory group in June and that those newer appointees cast the decisive votes in favor of lifting limits, while members who predated his appointments opposed the change.

The recommendation is not binding. Ars reported that the FDA can still reject the panel’s advice, but doing so could create conflict between agency scientific staff and Kennedy’s policy preference. The article also cited The New York Times as reporting that, when asked whether the FDA had previously approved a product never tested in humans, an agency official said it had not.