lunes, 23 de febrero de 2026

The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding February 23, 2026 By Karla L. Palmer & Sara W. Koblitz —

https://www.thefdalawblog.com/2026/02/the-governments-warning-shot-fda-and-hhs-turn-up-the-pressure-on-compounding/?utm_source=rss&utm_medium=rss&utm_campaign=the-governments-warning-shot-fda-and-hhs-turn-up-the-pressure-on-compounding Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled down on its own compounded semaglutide pill formulation. This likely was the spark that caused FDA’s Commissioner Marty Makary to tweet a not-so-subtle threat to compounders: FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.

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