Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

Robert F. Kennedy Jr., the Health Secretary of the Make America Health Again movement, has taken it upon himself to allow six specific peptide drugs to be sold by specialty pharmacies, despite the Food and Drug Administration's (FDA) warnings. These peptides have gained popularity among Kennedy's supporters and many prominent figures within the MAHA.

Kennedy himself admits to using some of the peptides, stating that he is a "big fan." However, FDA scientists insist that there is not enough evidence to prove their safety or efficacy. In response to safety concerns, the FDA removed these peptides from the list of drugs that specialty pharmacies, known as compounding pharmacies, could create in 2023.

Kennedy's new rule, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," bypasses the need to formally reverse the FDA's previous decision. The rule, published on Wednesday in the Federal Register, is set to take effect on October 30. It does not alter the regulatory status of the peptides; instead, it grants the Department of Health and Human Services (HHS) the authority to no longer take enforcement action against compounding pharmacies for manufacturing and selling these drugs.

This effectively gives the pharmacies a green light to freely produce and sell the peptides. Kennedy proposed this rule quietly earlier in the month.