AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court
FDA Law Blog
MARCH 5, 2024
According to AstraZeneca, the statute defines a qualifying single source drug by reference to its individual “approval,” and “any other reading. The court also found that the company could not win on its Fifth Amendment argument because it did not have a protected property interest. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).
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