FDA science staff voted against new peptide rule

The majority of scientific staff at the Food and Drug Administration opposed a new policy that permits specialty pharmacies to sell unproven peptide drugs, according to six people familiar with the internal discussions. These officials spoke on the condition of anonymity because they were describing confidential government deliberations.

The Department of Health and Human Services posted the document online on Wednesday. It covers a specific group of injectable peptides, including BPC-157, TB-500, and KPV, which are marketed in the wellness sector for muscle building, injury healing, and energy boosts. An HHS spokesperson did not immediately respond to a request for comment.

The policy directs the FDA to refrain from taking action against specialty pharmacies that sell these six compounds. Without this directive, the chemicals would be treated as illegal drugs under current FDA rules because they have not undergone the agency's standard review for safety and effectiveness. Health Secretary Robert F Kennedy Jr, who favors the plan, has described himself as a big fan of peptides and recently stated he used BPC-157 to treat a muscle injury.

The final document represents a shift from earlier HHS proposals. Officials initially wanted the FDA to write a formal regulation adding these peptides to a list of substances considered safe for compounding pharmacies. FDA officials reported that agency scientists had major safety concerns and would not support a regulation deeming the substances safe. HHS then moved to a strategy of directing the FDA not to enforce its existing rules against pharmacies that compound the drugs.

FDA staff provided technical input on the final plan, including safeguards that require pharmacies to source ingredients from FDA-registered factories. The policy also directs compounders to collect side effect data for safety analysis and to verify the chemical identity of the peptides. This approach avoids a direct conflict with FDA staff because it instructs the agency to pause enforcement rather than change its scientific standards.

Decisions on compounding have historically rested with the FDA, not HHS, which maintains an office dedicated to protecting consumers from unsafe compounded drugs. Agency attention to the issue increased after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts compounding pharmacy. Former FDA officials noted it is extremely rare for HHS to lead policy drafting on compounding, although federal law grants HHS authority over drug regulation, which it typically delegates to the FDA.

Kennedy has argued that US compounding pharmacies must be allowed to sell peptides to prevent Americans from relying on gray market products imported from China and other countries. Many consumers currently order vials online from Chinese chemical manufacturers, often labeled for research use only to bypass US regulations. In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to a list of substances that should not be compounded, citing risks of allergic reactions, kidney damage, and tumor growth. At a July meeting, agency staff reiterated that more than half a dozen peptides under reconsideration remained unproven for safety and effectiveness.