AP report: FDA scientists opposed the Trump administration's move to ease peptides access

A proposed policy for U.S. access to untested peptide drugs, backed by Health Secretary Robert F. Kennedy Jr., encountered significant opposition from Food and Drug Administration (FDA) scientific staff, according to six sources familiar with the policy's creation. The policy, outlined by the Department of Health and Human Services (HHS) and posted online, covers various injectable peptides marketed for wellness purposes like muscle building, injury healing, and energy enhancement.

The FDA's scientific personnel, who had limited involvement in drafting the policy, expressed concerns that it could undermine the agency's mandate to prevent unproven health products from entering the U.S. market. The FDA had previously directed specialty pharmacies selling these peptides not to take action against them, as they would be considered illegal drugs due to lack of FDA approval.

The HHS policy essentially instructs the FDA not to enforce specific rules against pharmacies that compound the substances, thereby avoiding a direct conflict with the FDA's stance. Despite these measures, FDA scientists emphasized the need for regulatory safeguards, such as sourcing ingredients from FDA-registered facilities and monitoring side effects.

The policy reflects a compromise between HHS's desire to expand access to peptides and FDA's commitment to ensuring patient safety.