Whole Woman’s Health Alliance et al. v. U.S. Food and Drug Administration et al.

Docket No.
3:23-cv-00019
District Court
Virginia

Goal

  • Declaration that all or part of FDA's mifepristone REMS are unconstitutional
  • Declaration that all or part of FDA's mifepristone REMS violate the APA
  • Declaration that approval of mifepristone is lawful and valid
  • Enjoin defendants from implementing mifepristone REMS

Litigation Content

Why this Matters:

The Plaintiffs allege that the Food and Drug Administration (FDA) violated the Equal Protection Clause of the U.S. Constitution and the Administrative Procedure Act by subjecting mifepristone to burdensome requirements that makes the drug extremely difficult to access and prescribe. Ensuring that individuals have access to safe and effective medication abortions enables patients to receive necessary reproductive health care.

Potential Impact:

Unnecessary restrictions on safe and effective drugs can create obstacles for doctors to promote medically appropriate care and jeopardize the health and safety of patients seeking medication for abortion services.