THE LATEST: On January 25, GenBioPro, the manufacturer of generic mifepristone – which is approved by the U.S. Food and Drug Administration (FDA) as part of a two-drug regimen for the termination of early pregnancy – sued to block West Virginia’s ban on abortion and associated restrictions that restrict access to the medication. The suit, filed in federal court, alleges that a state abortion ban passed in the aftermath of Dobbs and other restrictions as they apply to medication abortion, violates the Supremacy Clause and the Commerce Clause of the U.S. Constitution.  

GenBioPro’s suit, which is the first of its kind to be filed since Dobbs, affirms that FDA’s congressionally-mandated authority to impose regulations on the prescription and distribution of mifepristone in a way that carefully balances patient need and safety supersedes state efforts to restrict access to medications. It also comes on the heels of FDA’s announcement earlier this year that enabled mifepristone to be accessed through certified pharmacies and through the mail.  

GenBioPro is represented in the suit by a team of lawyers from Kellogg, Hansen, Todd, Figel & Frederick, Democracy Forward Foundation, Arnold & Porter, and Powell & Majestro.

 BACKGROUND – GenBio Pro, Inc. v. Patrick Morrisey & Mark A. Sorsaia

West Virginia’s legislature passed the Unborn Child Protection Act following the Supreme Court’s Dobbs decision that stripping federal abortion protections. The law, which bans abortion in the majority of cases, joined a prior state restriction on prescribing mifepristone through telemedicine. 

Medication abortion using the two-drug regimen involving mifepristone early in pregnancy is the most common and preferred form of abortion care in the United States, representing more than half of all pregnancy terminations. Despite the FDA’s established scientific authority and majority support from voters nationwide who say states should not be able to ban FDA-approved medications including abortion medications, extremists continue to threaten basic access to mifepristone – an FDA-approved medication that has been used safely and effectively to end a pregnancy for more than 20 years. 

In January, the Attorney General of West Virginia, joined a letter in which a number of state attorneys general proclaimed to FDA that they “will not yield” to FDA’s federally based authority to approve drugs and strike the optimal regulatory balance between risk mitigation and ensuring patient access.

People living in West Virginia who need this basic health care are being forced to travel out of state or forgo care altogether. Even before the state’s abortion ban took effect, severe state restrictions obstructed West Virginia residents’ access to mifepristone, stifling GenBioPro’s ability to conduct business in that state compared to others in the region. Congress preempted these state laws by determining that FDA alone may impose restrictions on the prescription and distribution of mifepristone and must do so in a way that minimizes the burden on the healthcare delivery system in violation of the Constitution’s Supremacy Clause. 

Read the release here.