FDA Staff Oppose Draft Guidance on Unproven Peptides

A draft guidance document at the Food and Drug Administration would allow specialty pharmacies to sell specific unproven peptide drugs without immediate regulatory action. Six people familiar with the document’s development said the plan faces internal resistance from scientific staff. The policy aligns with the preferences of Health and Human Services Secretary Robert F. Kennedy Jr.

The guidance covers injectable peptides popular in the wellness sector. It recently completed regulatory review at the White House, a step typically taken before publication. Three of the sources stated the document instructs the FDA not to act against specialty pharmacies that sell these specific compounds. Without this guidance, the substances are technically illegal drugs because they have not passed the agency’s review for safety and effectiveness.

The individuals spoke on condition of anonymity to discuss confidential deliberations. A Department of Health and Human Services spokesperson did not immediately respond to requests for comment. The policy targets substances like BPC-157 and TB-500. These are promoted as aids for injury healing and muscle building. International sports authorities classify them as doping substances.

Kennedy has described himself as a fan of peptides. He recently noted using BPC-157 to treat a muscle injury. He has argued that U.S. compounding pharmacies must be permitted to sell these products. He cited a trend of Americans buying imported vials from China, often labeled for research use only, to bypass U.S. rules.

Two sources indicated the current draft is a retreat from earlier HHS plans. Officials initially wanted the FDA to write a formal regulation adding these peptides to a safe-for-compounding list. FDA officials warned that agency scientists had major safety concerns and would not support such a rule. HHS subsequently shifted to an enforcement-based approach. This method avoids a direct conflict with FDA staff while still allowing sales.

FDA staffers provided technical input on the plan, including safeguards to improve safety. Pharmacies would be required to source ingredients from FDA-regulated factories. They must also collect side effect data and verify chemical identity. Industry groups, including the Alliance for Pharmacy Compounding, have met with White House officials and support these measures.

Decisions on compounding have historically come from the FDA, which maintains a dedicated office for this purpose. Former FDA officials note it is rare for HHS to lead policy drafting in this area. Compounding became a multibillion-dollar industry after the 2012 fungal meningitis outbreak linked to a Massachusetts pharmacy. In 2023, the FDA added more than a dozen peptides to its list of substances not to be compounded due to risks like kidney damage and tumor growth.

At a July meeting, FDA staffers reiterated that more than half a dozen peptides under reconsideration remained unproven for safety and effectiveness. The draft guidance stands as a new approach to a long-standing regulatory question.