Inactive Case

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

Docket No.
8:21-cv-00198
District Court
Maryland

Goal

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

Issues

Why this Matters:

The plaintiff argues that a federal regulation that governs how claims related to the 340B program are resolved violate the Administrative Procedure Act and the Appointments Clause of the Constitution. The growth of the 340B program and practices by drug manufacturers and certain providers—including the overcharging for 340B drugs and diversion of these drugs — have amplified the need for the federal government to take measures to ensure compliance with the law and lower health care costs.


Potential Impact:

Preventing the federal government from adopting a robust dispute resolution process will hamper accountability of conduct by the manufacturers and providers and limit the Department of Health and Human Services’ oversight of the 340B program.

33 Major Filings

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Related Litigation

Current Status

Case dismissed

Legal Issues

Administrative Procedure Act - Arbitrary and Capricious, Administrative Procedure Act - Contrary to Law, Appointments Clause

Amicus Briefs for Defendant(s)

Genesis Health Care, Inc.

Date Filed
January 22, 2021
Case Type
Civil
Court Type
District Court
Court
Maryland
Court Division
Southern
Judge
Grimm, Paul W. Appointed By: Barack Obama
Plaintiff(s)
Pharmaceutical Research and Manufacturers of America
Lead Counsel For Plaintiff(s)
Sidley Austin LLP
Defendant(s)
Xavier Becerra; Department of Health and Human Services; Diana Espinosa; Health Resources and Services Administration
Lead Counsel for Defendant(s)
Government