AstraZeneca Pharmaceuticals LP et al. v. Kennedy et al.

Docket No.
26-2165
Appellate Court
Fourth Circuit

Goal

  • Block enforcement of an agency action
  • Compel agency action
  • Declaration that an agency action is unlawful
  • Vacate agency action

Litigation Content

Why This Matters:

Why This Matters

The plaintiffs argue that the Inflation Reduction Act’s Medicare drug negotiation process violates the Administrative Procedure Act. Medicare’s authority to negotiate the price of certain single-source, high-priced drugs is estimated to result in substantial savings for Medicare beneficiaries and the federal government. This appeal challenges the district court’s ruling that CMS’s definition of qualifying single-source drug does not violate the APA.

Potential Impact:

Potential Impact

Successful challenges to Medicare’s negotiation authority would negate savings to Medicare beneficiaries and taxpayers and could severely restrict federal regulatory authority in the health care arena.

Litigation Information

Current Status

Briefing is ongoing

Important Date

Joint Appendix and Plaintiffs' Opening Brief Due