AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court
FDA Law Blog
MARCH 5, 2024
AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).
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