US Health Secretary overrides FDA to authorize sale of six peptide drugs
Secretary Robert F. Kennedy Jr. has issued a policy permitting compounding pharmacies to manufacture and sell six specific peptides, bypassing FDA safety restrictions.
Health Secretary Robert F. Kennedy Jr. has directed the Department of Health and Human Services (HHS) to cease enforcement actions against compounding pharmacies producing six specific peptide drugs. The policy, titled 'Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,' effectively allows these substances to re-enter the market despite prior FDA objections.
In 2023, the FDA removed these peptides from the list of substances authorized for compounding due to concerns regarding clinical efficacy and potential patient safety risks. Agency scientists argued that evidence failed to support the medical utility of the compounds, categorizing them as potentially hazardous for public consumption.
The new HHS policy does not formally overturn the FDA's regulatory classification. Instead, it utilizes administrative discretion to prevent the federal government from prosecuting pharmacies that manufacture these drugs. The rule was filed in the Federal Register this week, with final publication scheduled for October 30.
This decision marks a significant deviation from standard FDA review processes. The peptides in question have gained popularity within the 'Make America Health Again' movement, with several prominent figures associated with the group involved in the distribution of these supplements.