Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is advancing plans to ease access to unproven peptide drugs popular with members of Kennedy's Make America Healthy Again movement. The move comes despite FDA staff scientists finding that these drugs have not been sufficiently studied to establish safety and efficacy and may cause harm.
The FDA submitted an "Interim Access Policy" on peptides for White House review, according to a filing notice posted on an Office of Management and Budget website. The notice does not describe the proposed policy. However, people familiar with the proposal told The Associated Press that it would give the FDA "enforcement discretion" on certain peptide drugs, allowing the agency to choose not to enforce current restrictions. It would also assure specialty pharmacies eager to begin making the drugs that they will not be targeted.
The Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment from Ars Technica. The proposal arrives as the FDA re-reviews a dozen popular but unproven injectable peptide drugs. In 2023, FDA scientists determined the peptides lacked adequate safety and efficacy data and posed risks, and they were removed from a list of drugs that compounding pharmacies can make.
Despite those concerns, sellers continue to promote the drugs, claiming without evidence that they can improve appearance, boost energy and help heal injuries. Peptides are especially popular among the MAHA crowd, where many prominent figures sell peptide products. Kennedy, a self-proclaimed "big fan" of peptides, vowed to end "FDA's war" on them when he took office.
Source: Ars Technica · Summarized by HeadlinesBriefing