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

Docket No.
26-02165
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.

2 Major Filings

Litigation Information

Current Status

Briefing is ongoing

Important Date

Plaintiffs' Opening Brief Due