Pharmaceutical Research and Manufacturers of America v. Kennedy et al.

Docket No.
1:26-cv-03498
District Court
District of Columbia

Goal

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

Litigation Content

Why This Matters:

Why This Matters

A drug manufacturer trade group, PhRMA, challenges a new drug payment model from the Center for Medicare and Medicaid Innovation (CMMI) known as Global Benchmark for Efficient Drug Pricing (GLOBE). GLOBE uses international drug pricing information to calculate rebates that manufacturers must pay under Medicare Part B.  PhRMA argues that GLOBE is invalid under the Administrative Procedure Act because it employs standards outside CMMI’s authorizing statute and violates the major questions doctrine. PhRMA also asserts that GLOBE is unconstitutional because it violates the Presentment Clause and the nondelegation doctrine.

Potential Impact:

Potential Impact

The rising costs of prescription drugs have rendered them unaffordable for many individuals and families. New efforts to lower prescription drug prices nationwide could be impeded by successful litigation.

1 Major Filings

Litigation Information

Current Status

Briefing is ongoing