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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.
Peptides and Safety Concerns
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.
New Enforcement Discretion Policy
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 data 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.
Questionable Rationale
Along with the notice in the Federal Register, HHS also posted a more detailed explanation of the policy today that includes more of Kennedy’s rationale for easing enforcement of the six select peptides, which are: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
