Kennedy proposes limited access to six unapproved peptides

US Health Secretary Robert F. Kennedy Jr has set out a draft policy that would make it easier for licensed pharmacies and doctors to prepare medicines using six peptides that have not been approved by the Food and Drug Administration (FDA). The change would be a limited decision not to take enforcement action under specified conditions, rather than approval of the substances as medicines.

The proposal covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. It applies to medicines prepared for individual patients on prescription, using ingredients that meet requirements for sourcing and testing. Preparers would have to report serious adverse events. Each prepared product could contain only one of the six listed active ingredients; the policy would not permit them to be combined in a single product.

Kennedy’s Department of Health and Human Services (HHS) argues that this route could give patients a more controlled alternative to peptides sold as research products. An HHS spokesperson told CBS News: “The policy does not grant FDA approval or establish clinical safety and effectiveness.” Medicines prepared in this way are not reviewed by the FDA for safety, effectiveness or quality before marketing.

The proposal follows a disagreement over how to regulate the substances. In briefing papers for a July advisory meeting, FDA staff proposed keeping the forms under consideration off the regular list of bulk ingredients permitted for pharmacy compounding. The advisory committee voted in favour of their inclusion, according to HHS. That vote was advice, not an FDA decision or drug approval; HHS says its interim approach also draws on information obtained after the staff assessments.

One FDA assessment illustrates the clinical uncertainty. For BPC-157 as a treatment for ulcerative colitis, staff found that a single small trial did not provide enough evidence to establish effectiveness. That finding concerns that substance and use, not all six peptides.

The notice was made public on 28 October and was scheduled for publication in the Federal Register on 30 October, followed by two weeks for comments. The draft says it is not binding. When any resulting policy would take effect, and how it would work in practice, remains unclear.