Robert F. Kennedy Jr. announced on Wednesday that he would permit widespread patient access to unapproved peptide injections popularized by internet influencers, overriding F.D.A. safety recommendations. The policy uses "enforcement discretion" to let companies produce the injections without standard drug approval processes, bypassing tests for efficacy and safety.
The six peptides include epitalon, marketed for longevity, and BPC-157, known as the "wolverine" peptide for muscle repair. H.H.S. spokeswoman Emily Hilliard said the policy requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting. It aims to counter black-market peptides but does not grant F.D.A. approval or establish clinical safety.
F.D.A. scientists previously advised against widespread use, and none attended meetings finalizing the policy. Dr. Janet Woodcock, a former F.D.A. official, warned the move resembles unregulated folk medicine that historically caused harm. The policy requires manufacturing at F.D.A.-registered facilities, though this mainly requires notifying the agency of an address.
Telehealth companies like Hims & Hers and Noom are positioned to dispense the peptides through compounding pharmacies. The decision aligns with the "medical freedom" movement championed by Mr. Kennedy's supporters, who favor treatments with limited scientific evidence.
Source: New York Times Top Stories · Summarized by HeadlinesBriefing