FDA under Kennedy submits policy to ease enforcement on unproven peptide drugs
The Health and Human Services Department, led by Robert F. Kennedy Jr., has proposed giving the FDA 'enforcement discretion' on peptide drugs despite staff scientists finding insufficient safety and efficacy data.
What happened
The FDA submitted an 'Interim Access Policy' on peptides to the White House Office of Management and Budget for review. According to people familiar with the proposal, the policy would grant the FDA 'enforcement discretion' on certain peptide drugs, allowing the agency to choose not to enforce current restrictions and assuring specialty compounding pharmacies they will not be targeted. This comes as the FDA is re-reviewing a dozen popular injectable peptide drugs that FDA scientists determined in 2023 lacked safety and efficacy data and posed risks, leading to their removal from the list of drugs compounding pharmacies can make. Kennedy has described himself as a 'big fan' of peptides and vowed to end the FDA's 'war' on peptides upon taking office.
Context
Peptide drugs are being marketed with unsubstantiated wellness claims—including improving appearance, boosting energy, and healing injuries—particularly among Kennedy's Make America Healthy Again movement, with prominent MAHA figures selling peptide products. The proposed policy would reverse the 2023 FDA determination by de facto allowing compounding pharmacies to produce these drugs without FDA enforcement action, despite the agency's own scientists concluding the drugs have not been sufficiently studied. This represents a significant shift in FDA regulatory posture on a category of drugs flagged by the agency's own staff as potentially harmful.
What's disputed
The specific details of the proposed Interim Access Policy are not publicly available; the OMB posting does not provide information on the policy itself, only that it has been submitted for review.