White House docket posts access policy for unapproved compounded peptides
FDA scientists had 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 23 18:45 ETSource: Piedmont Exedra
The wire
- 01A temporary access policy appeared on a White House docket October 14 proposing to let licensed pharmacies make and sell certain unapproved peptides directly to consumers, KFF Health News reports.
- 02Clinics selling BPC-157 and similar products would gain cover from a federal policy, while FDA staff warned in July that the drugs have not been adequately tested in clinical trials.
- 03KFF notes several advisory committee members have financial stakes in peptide businesses; HHS says all members meet FDA ethics requirements, and the policy's final form and timing remain unsettled.
From the source
Read at piedmontexedra.com4 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)
