Trump administration advances plan for peptide drugs favored by RFK Jr.
The proposal was quickly praised online by some Kennedy allies who sell peptides.
TL;DR
- U.S. health officials are advancing a plan to allow specialty pharmacies to produce certain peptides.
- The plan was submitted by the Department of Health and Human Services for White House review.
- Peptides are building blocks of proteins used for growth, metabolism, and healing, with some approved as medications for diabetes and weight loss.
- The peptides at issue have not undergone rigorous vetting and are popular for unapproved uses like bulking up, looking younger, or boosting energy.
- Health Secretary Robert F. Kennedy Jr. previously advocated for ending the FDA's "war" on peptides and allowing U.S. compounding pharmacies to sell them.
- The proposed policy would allow temporary compounding of popular peptides, such as BPC-157, which is promoted for muscle building and injury healing.
- This initiative aligns with efforts by Kennedy and other officials to ease access to unproven products popular within the "Make America Healthy Again" movement.
- The FDA had previously flagged certain peptides as too risky for compounding due to potential risks like contamination and allergic reactions.
- An external FDA advisory panel recommended dropping restrictions on several peptides, a decision that went against FDA staff scientists' conclusions on safety and effectiveness.
- The new policy would employ "enforcement discretion," allowing the FDA to selectively not enforce regulations against compounding certain peptides.
- The peptide business is attracting attention from telehealth providers, with an estimated market value of $2 billion to $3 billion.