HHS sends peptide plan to White House for review — SkimNews
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- HHS submitted a peptides "interim access policy" to the White House's Office of Management and Budget for review, per a Thursday posting on a government website.
- The proposed policy would allow compounding pharmacies to temporarily produce peptides including BPC-157 — a chemical promoted for muscle building and injury healing — through FDA "enforcement discretion" so pharmacies would not be targeted.
- Kennedy, before joining the administration, declared that "FDA's war" on peptides would soon end, and earlier this year directed the agency to reconsider a short list of peptides promoted by wellness influencers.
- An FDA advisory panel selected by HHS recommended in July that the agency drop restrictions on 6 of 7 peptides reviewed, going against FDA staff scientists who said none had been adequately studied to establish safety and effectiveness.
- The FDA had previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky to compound, citing potential contamination, allergic reactions and tumor growth.
- Hims & Hers and Noom recently announced plans to offer peptides if federal access eases, with Wall Street analysts estimating the market at $2 billion to $3 billion.
Why it matters: This formalizes — via OMB review — Kennedy's push to let compounding pharmacies sidestep FDA compounding bans on peptides whose safety agency scientists say is unproven. Consumers gain easier access to popular wellness injections, while Hims & Hers, Noom, and specialty clinics eye a $2 billion to $3 billion market the FDA had previously kept off-limits.
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