RFK Jr. proposes FDA ease access to unproven peptide drugs, report says

Key facts

• FDA scientists found popular peptide drugs lack sufficient safety and efficacy data.
• The proposed policy would give the FDA "enforcement discretion" on certain peptide drugs.
• The advisory panel recommended adding six peptides back to the list of drugs compounding pharmacies can make.
• The Center for Science in the Public Interest urged the FDA to disregard the panel's recommendations.

Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving to ease access to unproven peptide drugs, despite internal scientists' concerns about their safety and efficacy. The FDA has submitted an "Interim Access Policy" for peptides to the White House for review. This policy would allow the agency "enforcement discretion" on certain peptide drugs, meaning it could choose not to enforce current restrictions and assure specialty pharmacies they would not be targeted.

The proposal comes as the FDA is re-reviewing a dozen popular, but unproven, injectable peptide drugs. In 2023, FDA scientists found these peptides lacked data on safety and efficacy and posed risks, leading to their removal from a list of drugs that compounding pharmacies can make. Despite this, sellers make unsubstantiated claims about their benefits, and they are popular among Kennedy's "Make America Healthy Again" movement.

In April, the FDA announced it would reconsider 12 unproven peptides. In June, Kennedy appointed nine new members to a 13-member FDA advisory panel, at least six of whom have ties to peptide-related businesses and clinics. In a July meeting, the panel voted to recommend adding six of the first seven peptides considered back to the list of drugs compounding pharmacies can make, overriding FDA staff scientists.

The Center for Science in the Public Interest (CSPI) is strongly opposing Kennedy's efforts. The group sent a letter to Acting FDA Commissioner Kyle Diamantas urging him to disregard the panel’s recommendations, warning that "charlatans will continue to put unsuspecting consumers at risk of serious injury."