FDA scientists voted against peptide policy backed by health secretary

Most scientific staff at the Food and Drug Administration opposed a new policy that allows specialty pharmacies to sell six unapproved injectable peptides, according to six people familiar with the deliberations. The policy, favored by Health Secretary Robert F Kennedy Jr, was published online by the Department of Health and Human Services on Wednesday. The individuals spoke on condition of anonymity because they were discussing confidential government discussions.

The plan directs the FDA not to take action against pharmacies that sell wellness peptides, including BPC-157, TB-500, and KPV. These chemicals are promoted in the wellness industry for building muscle, healing injuries, and boosting energy. Under existing FDA rules, these substances are considered illegal drugs because they have not undergone agency review for safety and effectiveness. Kennedy has described himself as a big fan of peptides and recently stated that he used BPC-157 to treat a muscle injury.

The current document represents a change from the department's initial approach. HHS officials originally intended for the FDA to write a formal regulation adding BPC-157 and other peptides to a list of safe substances for compounding pharmacies. FDA officials responded that agency scientists had major safety concerns and would not support a regulation deeming the substances safe. HHS subsequently shifted its strategy to directing the FDA not to enforce its rules against pharmacies that compound these products.

FDA staff provided technical assistance on the final plan, which includes safeguards such as requiring pharmacies to source ingredients from FDA-registered factories. Compounders are also directed to collect information on side effects for safety analysis and to verify the chemical identity of the peptides. This approach avoids a direct clash with FDA staff because it only instructs the agency not to enforce specific rules.

Decisions on compounding have historically rested with the FDA rather than HHS. The FDA's focus on the issue expanded after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts compounding pharmacy. Former FDA officials noted that it is extremely rare for HHS to lead policy drafting on compounding, although federal law gives HHS authority over drug regulation, which it typically delegates to the FDA.

Kennedy argued that US compounding pharmacies must be allowed to sell peptides because Americans are turning to gray market products imported from China and other countries. Many users currently order vials online from Chinese chemical manufacturers, who often label products for research use only to sidestep US rules. The FDA added more than a dozen peptides to its do-not-compound list in 2023, citing risks of allergic reactions, kidney damage, and tumor growth. At a July meeting, agency staff reiterated that the peptides up for reconsideration remained unproven for safety and effectiveness.

An HHS spokesperson did not immediately respond to a request for comment regarding the policy. The document covers a handful of injectable peptides that have not been approved by the FDA as safe and effective. The policy aims to address the availability of these substances in the United States.