Science-Based Medicine faults FDA panel vote on six compounded peptides
The essay argues peptide is a molecule class, not a regulatory category, and that evidence for socially promoted peptides often lags far behind the claims.
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By Maren Holt · Senior Reporter, GLP-1
Oct 22 09:19 ETSource: Science-Based Medicine
The wire
- 01The commentary notes the FDA's Pharmacy Compounding Advisory Committee recommended in July adding six of seven nominated peptides to the 503A bulks list, against FDA staff briefing documents citing limited safety and efficacy evidence.
- 02It draws a line between peptides vetted through research and review, such as insulin and semaglutide approved in 2017, and compounded peptides sold on claims that outrun their data.
- 03This is opinion, not new agency action; the author's concern is label-versus-contents mismatch of the kind that drove the 1906, 1938 and 1962 drug laws.
From the source
Read at sciencebasedmedicine.orgSnake Oil to Compounded Peptides: Why We Ask For Evidence
Clark Stanley’s Snake Oil Liniment promised relief from rheumatism, neuralgia, sciatica, sprains, toothache, and frostbite. When federal investigators finally tested it, they found mineral oil, fat, red pepper, and turpentine. The snake oil contained no snake.
