White House docket posts temporary access policy for unapproved compounded peptides
KFF Health News reports FDA scientists advised against the measure in July, but an advisory panel with new appointees tied to the peptide industry voted to loosen restrictions.
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By Daniel Okafor · Regulatory Correspondent
Oct 19 08:15 ETSource: Sierra Sun Times
The wire
- 01A temporary access policy appeared on a White House docket on October 14 proposing to let licensed pharmacies make and sell certain unapproved peptides to patients, despite FDA staff warnings that the drugs have not been adequately vetted in clinical trials.
- 02Health secretary Robert F. Kennedy Jr. and MAHA figures have pushed for broader peptide access; one committee member who voted yes, Haleem Mohammed, is chief medical officer of Gameday Men's Health, a men's clinic that sells peptides.
- 03HHS spokesperson Emily Hilliard says every committee member satisfies FDA ethics requirements. The piece also flags marketing claims that peptides are not drugs, which legal experts dispute.
From the source
Read at goldrushcam.comKFF Health News: Four Red Flags and One Truth Amid the Peptide Hype
Experimental peptides are often sold at longevity, wellness, and “performance medicine” clinics — even though they haven’t proved safe and effective in clinical trials. (Amy Maxmen/KFF Health News)
