Kennedy’s draft HHS policy would ease access to six unapproved peptides

Health and Human Services Secretary Robert F. Kennedy Jr. filed a draft policy on October 28 that would allow licensed pharmacies and physicians in the United States to compound six unapproved peptides without HHS enforcement action under specified safeguards, CBS News reported. The move could give patients a regulated route to substances already promoted for wellness, although HHS says it does not establish their safety or effectiveness.

The substances are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. NBC News described the measure as temporary enforcement discretion: compounders can begin offering them while they remain off the Food and Drug Administration’s list of ingredients permitted for compounding. Compounding pharmacies prepare customized medicines for individual patients.

What the peptide policy requires

Kennedy argued that access through licensed compounders would offer patients a more controlled alternative to unregulated sellers. NBC News reported that HHS likewise presented the measure as a response to the gray market for peptides. These substances have been promoted online for purported benefits ranging from faster healing to longer life, but FDA scientists concluded there was insufficient evidence to establish that the six are safe and effective, NBC reported.

FDA staff concerns and the next decision

Most FDA scientific staff members opposed the plan and had limited input in drafting it, the Associated Press reported, citing six people familiar with its development. HHS ultimately incorporated several safeguards suggested by FDA staff, according to two of those people. An FDA advisory panel had recommended allowing the six substances in compounding in July, CBS News reported, but its recommendation was not FDA approval and ran against the agency scientists’ assessment.

The policy has also drawn criticism outside the agency. Shabbir Safdar, executive director of the Partnership for Safe Medicines, told NBC News that easing access would expose Americans to ‘untested, dangerous substances.’ His warning reflects the unresolved question at the center of the policy: whether tighter controls on compounding can reduce risks when clinical safety and effectiveness have not been established.

Public comment on the draft is scheduled to open October 30 and run through November 13, CBS News reported. The policy is intended to remain in place until the FDA finalizes a rule on compounded peptides; the agency had not proposed one at the time of the report.