FDA scientists opposed the Trump administration’s effort to ease peptides access

A plan to provide easier access to unproven peptide drugs, favored by Health Secretary Robert F. Kennedy Jr., was rejected by most FDA scientific staff members. The document, which addressed certain injectable peptides popular in the wellness industry, underwent regulatory review at the White House. Kennedy's Department of Health and Human Services (HHS) initiated the effort to ease access to peptides, which faced significant pushback from FDA drug staffers.

The policy aimed to prevent the FDA from taking action against specialty pharmacies selling specific peptides, substances not yet approved by the agency for safety and effectiveness. Peptides, naturally occurring in the human body, are used in various medications, including treatments for diabetes and weight loss. However, the peptides subject to the new policy have not undergone rigorous vetting by the FDA.

They include BPC-157 and TB-500, promoted for healing injuries and building muscle, but considered doping substances by sports authorities. Initially, HHS sought the FDA to create a regulation adding these peptides to a list of safe drug substances for compounding pharmacies. Yet, FDA officials raised safety concerns, leading HHS to instead instruct the FDA not to enforce its rules against compounding pharmacies.

FDA staffers provided technical assistance in drafting the HHS plan, including safety guidelines. Despite this, the policy avoids direct conflict with FDA concerns, focusing on directing the FDA not to enforce certain rules. The plan incorporates safety measures suggested by FDA staffers, such as sourcing ingredients from FDA-registered facilities and monitoring side effects.