Rebutting AZ’s IRA lawsuit, U.S. defends CMS procedures

The Department of Justice has asked a federal court to dismiss a lawsuit filed by AstraZeneca that challenges the constitutionality of the Inflation Reduction Act’s Medicare drug price negotiation program and asserts that the law violates the Administrative Procedures Act.

The government’s arguments are likely to be recycled in other cases that allege CMS has violated the APA by treating products approved under separate NDAs and BLAs as a single drug, and that challenge the way CMS defines a single source drug. ...