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

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 meaningful accountability of conduct by the manufacturers and providers and limit HHS’s oversight of the 340B program.