Piling On: AstraZeneca Files Sixth Manufacturer Lawsuit Against Medicare Negotiation Program

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.

The complaint, which also claims the Centers for Medicare and Medicaid Services violated the Fifth Amendment of the Constitution’s due...