An FDA advisory panel narrowly endorsed expanding access to certain compounded peptides, recommending broader manufacturing of four peptides—while closely weighing safety evidence, according to coverage of the Pharmacy Compounding Advisory Committee (PCAC) discussions. Panelists recommended against manufacturing others, setting up continued tension between patient access arguments and regulators’ evidence standards. The outcome came as health secretary Robert F. Kennedy Jr. promoted an approach to increase availability of unapproved peptide products, with the FDA retaining final decision authority. The panel’s split vote is likely to intensify scrutiny of how compounded drugs enter the supply chain, especially where clinical benefit data are limited.
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