RFK Jr. to ease access to unapproved peptides, draft policy states

Health and Human Services Secretary Robert F. Kennedy Jr. has proposed a draft policy that could potentially ease access to six unapproved peptide drugs for wellness purposes. The policy, which was filed this week, allows compounding pharmacies to prepare these peptides - BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500 - even though they lack FDA approval.

The Department of Health and Human Services aims to provide patients with a more controlled alternative through this policy, which includes stringent quality testing, safety reporting, and the requirement for FDA-registered ingredient makers. However, it's important to note that the policy does not grant FDA approval or establish clinical safety and effectiveness for these peptides.

The decision was made based on a July FDA advisory panel recommendation, despite the panel's scientists recommending against it due to insufficient evidence of safety and effectiveness.

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