FDA Considers Easing Access to Unproven Peptide Drugs Despite Safety Concerns

The Food and Drug Administration, under Health Secretary Robert F. Kennedy Jr., is moving forward with a plan that could make certain unproven peptide drugs more accessible. The proposal comes despite FDA staff scientists finding that the drugs have not been studied enough to establish their safety or effectiveness and may pose health risks.

The FDA has submitted an “interim access policy” for the peptides to the White House for review, according to a filing notice posted on the Office of Management and Budget’s website. The notice does not describe the proposed policy.

However, people familiar with the proposal told The Associated Press that it would give the FDA “enforcement discretion” for certain peptide drugs. That could allow authorities to refrain from enforcing current restrictions, giving specialty pharmacies more assurance that they could manufacture the peptides without being targeted by regulators.

The Department of Health and Human Services, which oversees the FDA, did not respond to requests for comment from Ars Technica.

FDA Says Peptides Lack Sufficient Safety and Efficacy Data

The proposal comes as the FDA reviews more than a dozen popular but unproven injectable peptide drugs. In 2023, FDA scientists determined that the peptides lacked sufficient safety and effectiveness data and could pose a risk.

As a result, the drugs were excluded from the list of substances that can be manufactured by specialized compounding pharmacies. These pharmacies produce custom-made medications, often based on individual prescriptions.

Peptides Gain Popularity Among MAHA Supporters

Despite the concerns, peptide drugs have become increasingly popular. Sellers claim, without evidence, that the products can improve appearance, increase virility, and help heal injuries.

The drugs are especially popular among supporters of President Kennedy’s Make America Healthy Again, or MAHA, movement. Several prominent MAHA figures sell peptide products, while Kennedy has described himself as a “huge fan” of peptides.

Before taking office, Kennedy vowed to end what he called the FDA’s “war” on peptides.