Robert F. Kennedy Jr. allowed pharmacies to compound six FDA-unapproved peptides
Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday that HHS would exercise enforcement discretion for compounding pharmacies making six peptides not approved by the FDA, including BPC-157 and Semax. The Associated Press reported that FDA scientists opposed the change. HHS spokeswoman Emily Hilliard said the policy requires patient-specific prescriptions, quality testing and safety reporting.
More context
Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday that pharmacies could compound six FDA-unapproved peptides. The Department of Health and Human Services said it would exercise enforcement discretion, meaning it would not take action against pharmacies compounding the substances. The peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The BBC reported that the draft came from Kennedy’s office rather than the FDA. The FDA removed the six from its list of drugs eligible for compounding in 2023 over safety concerns, Ars Technica reported. According to six people familiar with the matter, FDA scientists had little role in the decision and objected to it, The Independent reported. The BBC reported that health experts caution against their use, citing a lack of human clinical trials and unknown long-term effects.
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Reporting
- The New York Times — Kennedy to Allow Broad Use of Unapproved Peptide Injections - The New York Times
- The Washington Post — RFK Jr. plans to make these 6 unapproved peptides available for temporary sale - The Washington Post
- Time — The Peptide Rush Has Begun - Time Magazine
- The Independent — RFK Jr says he will allow widespread unapproved injections despite prior FDA warnings - The Independent
- BBC News — US Health Secretary RFK Jr to expand access to unapproved peptides - BBC
- Houston Public Media — Trump administration will allow pharmacies to make popular peptides - Houston Public Media
- National Public Radio — HHS will let pharmacies make popular peptides not approved by the FDA - NPR
- arstechnica.com — Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA - Ars Technica
Verifier’s note
The New York Times, The Washington Post, Ars Technica, TIME, The Independent, BBC, Houston Public Media, and NPR report on the administration’s plan to expand access to unapproved peptides; several also report FDA scientists’ opposition or concerns. Houston Public Media’s report is NPR coverage, while the results otherwise align on the timing and substance of the plan.