RFK Jr. peptides panel backs easing FDA manufacturing limits
An FDA advisory panel voted to lift limits on four peptides despite safety questions, after Robert F. Kennedy Jr. added new members.
By Hana Yoshida · Markets Reporter
3 min read
An FDA advisory committee tied to the RFK Jr. peptides debate voted Thursday to recommend easing manufacturing limits on four peptides for human use, Ars Technica reported. The decision matters because the compounds lack the safety and effectiveness evidence normally associated with FDA-approved drugs, according to Ars Technica.
The panel was split, with members appointed after Health and Human Services Secretary Robert F. Kennedy Jr. took office providing the decisive support, Ars Technica reported. Votes on three more peptides were scheduled for Friday, according to the same report.
What did the FDA peptide panel decide?
The committee recommended removing restrictions that had blocked manufacture of four peptides by compounding pharmacies, Ars Technica reported. Compounding pharmacies make specialty medicines, and the Biden administration had barred them from producing many peptides that lacked adequate safety and efficacy data, according to Ars Technica.
The committee’s vote does not by itself change FDA policy. Ars Technica reported that the panel is advisory, meaning the FDA can accept or reject the recommendation.
That next step could put FDA staff in a difficult position, Ars Technica reported. Rejecting the panel’s recommendation would place the agency’s experts at odds with Kennedy, who oversees the department that includes the FDA, according to Ars Technica.
What are peptides?
Peptides are short chains of amino acids, similar in building blocks to proteins but much smaller, Ars Technica reported. Some medically important peptides, including insulin, have clear biological roles and have been approved through standard FDA drug-review processes, according to Ars Technica.
Other peptides are less understood. Ars Technica reported that many can be fragments produced when larger proteins break down, and scientists may have only limited lab evidence about what they do in cells, with no human testing showing whether they are safe or effective.
Developing that evidence can take years, according to Ars Technica. The report said results seen in cell cultures often fail to translate into successful drug candidates when tested in living organisms.
Kennedy’s role in the peptide decision
Kennedy had previously signaled interest in reversing limits on peptides, Ars Technica reported. The outlet reported that he added members to the advisory group in June, and that all but one of the new members had apparent interests connected to making or selling unapproved peptides.
Ars Technica reported that the members who were on the panel before Kennedy’s additions voted against lifting the restrictions. The newly added members supplied the votes needed to recommend loosening the rules, according to Ars Technica.
Kennedy had said independent experts would examine each substance using clinical, pharmacological and safety evidence, Ars Technica reported. The outlet said that no such evidence was presented at Thursday’s meeting.
The New York Times reported that, when a committee member asked whether the FDA had ever approved a product that had not been tested in humans, an FDA official answered that it had not. Ars Technica reported that this could become a central issue as the FDA decides whether to follow the panel’s advice.
This story draws on original reporting from Ars Technica.