The US government violated the Administrative Procedures Act by expanding the statutory definition of “qualifying single source drug,” and adding a new “bona fide marketing” requirement in its guidance implementing the Medicare price negotiation program, AstraZeneca PLC argues in a lawsuit against the US government filed in Delaware district court 25 August.
Piling On: AstraZeneca Files Sixth Manufacturer Lawsuit Against Medicare Negotiation Program
Firm leans into allegations that the US government violated the Administrative Procedures Act in implementing the program. More legal actions are expected from industry once CMS announces the first list of drugs subject to negotiation. Our lawsuit tracker will keep you apprised.
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