The Food and Drug Administration is preparing a policy that could relax controls on peptide medications that have not been proven safe or effective, according to a filing posted on the Office of Management and Budget website. The draft, titled an “Interim Access Policy” for peptides, has been sent to the White House for review. While the notice does not disclose the policy’s specifics, sources familiar with the proposal told the Associated Press that it would grant the agency “enforcement discretion” for certain peptide products. That language would allow the FDA to forgo enforcing existing rules on these drugs, giving specialty pharmacies confidence that they would not be targeted for distribution.
Health Secretary Robert F. Kennedy Jr. has championed the move, aligning it with the goals of his Make America Healthy Again movement, which promotes the use of these peptides despite concerns from FDA scientists that the compounds have not undergone sufficient study to confirm safety or efficacy and could pose health risks. The Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment from Ars Technica.