Kennedy Opens Door to Unproven Peptide Injections

Health Secretary Robert F. Kennedy Jr. just opened the door to a suite of trendy peptide injections—without requiring the usual federal proof that they're safe or effective. In a move that sidesteps standard FDA drug-approval trials, Kennedy announced he will use "enforcement discretion" to let compounders make six unapproved peptides, including epitalon and BPC-157, widely available by prescription, the New York Times reports.

• "The secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety," a document released Wednesday states.

Kennedy, who has touted his own peptide use, cast the shift as expanding "patient choice and freedom" and a way to pull buyers away from the black market. But FDA scientists had advised against broad use, and were absent from at least one key meeting. The AP, citing six people familiar with the development of the plan, reports that FDA scientists strongly opposed the policy pushed by the Department of Health and Human Services, fearing that it would undermine the agency's mission to keep unproven products off the market in the US. In July, an advisory panel packed with people connected to the peptide industry recommended easing access to the injections.

According to the AP's sources, HHS initially sought an FDA regulation declaring the peptides safe for compounding pharmacies to use. After pushback, the sources say, HHS changed course and directed the FDA not to enforce its rules against the pharmacies. Former top FDA official Janet Woodcock warned the policy undercuts basic drug testing, while other critics say patients may assume a government endorsement that doesn't exist.

• The FDA agreed to provide technical assistance in drafting guidelines, including several safety measures HHS agreed to, the AP's sources say.
• The policy "requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers," HHS spokeswoman Emily Hilliard said, per the Times. She said the agency aims to confront "the risks of black-market peptides" and acknowledged that the policy "does not grant FDA approval or establish clinical safety and effectiveness."