In GenBioPro, Inc. v. Raynes, (4th Cir., July 15, 2025), the U.S. 4th Circuit Court of appeals in a 2-1 decision, held that federal law regulating the abortion drug mifepristone does not pre-empt West Virginia's Unborn Child Protection Act which bans almost all abortions. The suit was brought by a manufacturer of generic mifepristone. The majority said in part:
We begin by addressing GenBioPro’s field preemption theory. GenBioPro argues that the FDAAA “occupied the field of regulating access to REMS drugs with safe-use elements.”... In its view, West Virginia’s abortion law intrudes into this field by restricting access to mifepristone.
We disagree. West Virginia’s abortion law and the FDAAA operate in different fields. West Virginia’s law regulates the incidence of abortion. It determines whether an abortion may be performed at all, prohibiting the procedure in all but a few specific circumstances. In contrast, the FDAAA permits the FDA to regulate how mifepristone must be prescribed and dispensed if and when a medication abortion is performed....
And even were we to assume the state and federal laws regulate the same field, that field is not one that Congress has occupied....
We last address GenBioPro’s contention that the West Virginia law conflicts with the FDAAA....
The company claims that it cannot comply with both federal and state law because the FDA has authorized the sale of mifepristone while the state has banned its use. It likewise argues that the West Virginia law poses an obstacle to the FDAAA’s goal of ensuring drug access. In its view, Congress struck a careful balance between drug safety and access, and West Virginia’s abortion law disrupts this balance by burdening access to mifepristone.
Both of these theories rely on the same flawed premise: that Congress intended to guarantee nationwide access to mifepristone when it enacted the FDAAA. We see no indication that it did....
Judge Benjamin dissented, saying in part:
By criminalizing medical providers and prohibiting medication abortions, then, West Virginia has exceeded the ability to regulate abortion as established in Dobbs and has trespassed on the FDA’s authority to regulate the safe use of and unburdened access to mifepristone.
Stated simply, the majority’s conclusion on this point focuses on regulation of abortion generally, despite the issue here being the state regulation of an otherwise federally approved drug—a much narrower focus. The federal government has clearly occupied the drugs with REMS and elements to assure safe use field, and West Virginia overreaches by seeking to add additional regulations to the same. Accordingly, field preemption applies....
Because the UCPA burdens patients and healthcare systems and imposes inconsistent regulation of mifepristone in ways not intended by Congress, conflict preemption also precludes the state law.
Metro News reports on the decision.
