An RFK Jr. peptide panel at the Food and Drug Administration voted Thursday to recommend lifting manufacturing restrictions on four peptides intended for human use, a decision that could reopen access through compounding pharmacies despite unresolved questions about safety and effectiveness.
The advisory committee was organized by the FDA, but Health and Human Services Secretary Robert F. Kennedy Jr. reshaped its membership before the vote. Ars Technica reported that Kennedy added members in June who, with one exception, had apparent financial or professional interests tied to making or selling unapproved peptides. The members appointed before Kennedy’s intervention voted against lifting the limits, while the newer members supplied the votes that carried the recommendation, according to Ars.
The committee is scheduled to vote on three more peptides Friday. Its recommendation is not binding. FDA officials can still reject it, although that would put agency experts at odds with Kennedy, who oversees HHS and has authority over FDA leadership.
What did the FDA peptide panel decide?
The panel recommended that restrictions be removed on manufacturing four peptides for human use. The practical target is compounding pharmacies, which make customized drugs and had been blocked under the Biden administration from producing many of these peptides because the products lacked the safety and efficacy data normally expected for drugs.
Kennedy had signaled earlier this year that he wanted to revisit that ban. He previously said independent experts would review each substance using clinical, pharmacological and safety evidence. Ars reported that no such body of 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 said it had not. That answer goes to the core problem: the vote was about access to substances that have not gone through the usual human testing process required to show whether a drug works and whether its risks are acceptable.
What are peptides?
Peptides are short chains of amino acids. Proteins are made from the same building blocks, but they are typically much longer. Some peptides are well understood and medically important, including insulin, which the FDA has approved through ordinary drug review channels.
Other peptides are biological fragments whose effects are much less clear. A peptide may bind to another protein and trigger a measurable response, or it may be broken down and reused by the body without doing much. Results from cells in a dish do not establish what happens in a human body, which is where many promising drug candidates fail.
That gap is why FDA scientists have been wary of broad access to unapproved peptides. The available evidence described at the meeting did not resolve whether the substances are safe, effective, or manufactured consistently enough for human use.
Kennedy, a public critic of vaccines, has also shown enthusiasm for peptides and has been described by Ars as a user of them. His ability to turn that interest into agency policy is the unusual part. The next decision belongs to the FDA, unless Kennedy’s pressure makes the advisory vote the agency’s answer in practice.
This story draws on original reporting from Ars Technica.
