FDA scientists opposed Trump administration’s move to ease peptide access
Summary
The Department of Health and Human Services issued a policy telling the FDA not to enforce certain rules against specialty pharmacies selling six unapproved wellness peptides. Most FDA scientific staff opposed the move, citing safety concerns, and had limited input in drafting it.Key Facts
- The policy covers injectable peptides promoted for muscle building, injury recovery and energy.
- The peptides include BPC-157, TB-500 and KPV; the FDA has not approved them as safe and effective.
- HHS first considered a regulation that would classify the peptides as safe for use by compounding pharmacies, but shifted to an enforcement policy after FDA staff raised concerns.
- FDA staff provided technical assistance and recommended safeguards, including using ingredients from FDA-registered factories.
- Health Secretary Robert F. Kennedy Jr. has called himself a fan of peptides and said he used BPC-157 for a muscle injury.
- Kennedy has argued that U.S. pharmacies should be able to sell peptides because Americans are turning to products from gray markets abroad.
- Federal law gives HHS broad authority over drug regulation, which it generally delegates to the FDA.
- A 2012 outbreak of fungal meningitis was linked to contaminated injections from a Massachusetts compounding pharmacy.
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