Anti-vaccine Health Secretary Robert F. Kennedy has unilaterally passed a rule that will allow specialty pharmacies to sell six specific peptide drugs, overruling scientists at the Food and Drug Administration.

The peptides are popular among members of Kennedy's Make America Health Again movement, and many prominent MAHA figures and Kennedy allies sell them. Kennedy said he uses some of the peptides and called himself a "big fan." But FDA scientists continue to say there is insufficient evidence to show if they're effective, and they are potentially dangerous. In 2023, the safety concerns led the FDA to remove the six peptides from a list of drugs that can be made by specialty pharmacies called compounding pharmacies—which make customized formulations of drugs for patients, or, in cases such as this, specialty drugs in bulk.

Kennedy's new rule sidesteps the need to formally undo that FDA action. The rule is titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" and was made available Wednesday on the Federal Register, with the final publication date set for October 30. The rule does not change the regulatory status of the peptide; instead, it states the Department of Health and Human Services (HHS) will no longer take enforcement action against compounding pharmacies for making the peptides, essentially giving them a green light to freely produce and sell them. Kennedy had quietly proposed this rule earlier this month.

Read full article

Comments

Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy's Make America Healthy Again movement—despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.

The FDA submitted an "Interim Access Policy" on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. The posting does not provide information on the proposed policy. But people familiar with the proposal told The Associated Press that it would give the FDA "enforcement discretion" on certain peptide drugs. This would allow the agency to choose not to enforce current restrictions on peptides and provide an assurance to specialty pharmacies eager to start making them that they will not be targeted by the agency.

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

Read full article

Comments