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Off-label (view source)

Revision as of 19:49, September 25, 2022

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== Background ==

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{{cquote|This reading of the Authorization comports with the background understanding of the Federal Food, Drug, and Cosmetic Act. The Act regulates drug distribution; it does not bar doctors from prescribing an approved drug (like hydroxychloroquine) for an off-label use (like COVID-19). ''See Caronia'', 703 F.3d at 153. The Association's complaint thus alleges that the Act permits off-label prescriptions. Compl., R.1, PageID 5-6. And the FDA even acknowledged this narrow reading of the Authorization's scope on appeal. Appellees' Br. 21; ''cf. Driehaus'', 573 U.S. at 165.}}

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''Ass'n of Am. Physicians & Surgs v. United States FDA'', 13 F.4th 531, 544 (6th Cir. 2021).

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{{cquote|e) Off-Label Use

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