Fifth Circuit upholds FDA removal of semaglutide, tirzepatide from shortage list
The court found any failure to use notice-and-comment rulemaking harmless, closing the main legal challenge to the end of shortage-based GLP-1 compounding.
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By Daniel Okafor · Regulatory Correspondent
Sep 10 03:00 ETSource: Clark Hill
The wire
- 01The Fifth Circuit rejected compounder challenges under the Administrative Procedure Act to FDA decisions declaring the semaglutide and tirzepatide injection shortages resolved.
- 02The rulings confirm compounders can no longer rely on shortage status to make copies of Ozempic, Wegovy, Mounjaro and Zepbound, affecting pharmacies, telehealth firms and med spas.
- 03The court held the FDA reasonably relied on manufacturer production and inventory data and adequately weighed contrary evidence from compounders, patients and clinicians.
From the source
Read at clarkhill.comFifth Circuit Upholds FDA on GLP-1 Shortage Decisions
The U.S. Court of Appeals for the Fifth Circuit upheld the FDA’s decisions removing semaglutide and tirzepatide injection products from the federal drug shortage list. The two cases involved Ozempic and Wegovy, manufactured by Novo Nordisk, and Mounjaro and Zepbound, manufactured by Eli Lilly. In both cases, compounding interests challenged the FDA’s determination that manufacturer supply could me
