AbbVie Inc. v. Kennedy et al.

Docket No.
1:26-cv-01190
District Court
District of Columbia

Goal

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

Issues

Litigation Content

Why This Matters:

Why This Matters:

The plaintiff, a drug manufacturer, challenges the Health Resources and Services Administrations’ (HRSA) oversight over the 340B drug discount program, which requires drug manufacturers to sell certain safety-net providers outpatient drugs at a discount. Federal law prohibits such providers from selling or transferring the discounted drug to a person who is not a patient of the provider.  HRSA’s guidelines implementing the 340B program define who qualifies as a “patient,” but the plaintiff argues that the definition is overly broad and inconsistent with the 340B statute.

Potential Impact:

Potential Impact:

A ruling in favor of the plaintiff would constrain HRSA’s interpretive authority under the 340B statute.

Litigation Information

Current Status

Briefing is ongoing

Important Date

Plaintiff's Response to Motion to Dismiss Due