We don’t venture into politics here at the DDL Blog, but sometimes we have to call them like we see them. A divided panel of the Fourth Circuit filed an opinion last week upholding a state law that essentially prohibits the sale and use of an FDA-approved drug within that state for its FDA-approved intended use. We have seen this play before, but with a different ending. More than 10 years ago, we wrote about a state law banning the sale and use of an FDA-approved pain medicine, i.e., state law purporting to ban behavior that federal law expressly authorized. The results there were orders enjoining the state law because federal law regulating the sale and use of prescription drugs impliedly preempted them.
Implied preemption, the bread and butter of the blog. So why then are we citing politics? Well, the prescription drug involved here was mifepristone, which the FDA has approved for use in medically induced abortions. In GenBioPro, Inc. v. Raynes, No. 23-2194, 2025 WL 1932936 (4th Cir. July 15, 2025) (to be published), the Fourth Circuit upheld a West Virginia law prohibiting abortion in most circumstances and with few exceptions. The plaintiff generic mifepristone manufacturer claimed that federal law regulating both the sale and use of mifepristone for its FDA-approved use preempted the state law.
The manufacturer was on solid footing. The FDA has not only approved mifepristone for use in medically induced abortions, but has also mandated a Risk Evaluation and Medication Strategy (or “REMS”) program under which only specially certified providers can prescribe and dispense the drug under specific protocols regarding treatment, handling, and recordkeeping. Id. at *1-*2. These are federal requirements, and under these circumstances, the manufacturer argued with substantial justification that federal law impliedly preempted West Virginia’s law prohibiting abortions and essentially banning the sale and use of an FDA-approved drug for its approved indication.
The district court upheld the West Virginia law, and the Fourth Circuit affirmed. It all started with Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022). And we don’t mean figuratively. The opinion cites Dobbs literally in the first sentence, setting our expectations and the tone of the opinion from the get go. In the view of this two-judge majority, Dobbs restored the states’ right to regulate abortion and allowing federal law to preempt such efforts would be “one small step short of defiance.” Id. at *1. More on this later.
How did this court get from the FDA’s well-established authority to regulate prescription drugs to an opinion that denigrates federal law as a “maze of provisions” enacted by a “distant sovereign,” which has to give way to a state’s “sovereign right to protect . . . health and safety”? Id. We know that implied preemption is grounded in the Supremacy Clause, which mandates that federal law is “the supreme law of the land. However, according to the Fourth Circuit, our version of federalism assumes that federal law will not supplant state law unless Congress clearly and manifestly intended that result. Id. at *5.
You can see where this is going: The presumption against preemption. (Regular readers of the blog can hear Bexis groaning). The Fourth Circuit invoked the presumption against preemption (and other unrelated presumptions) to erect a protective barrier around state regulation of health and safety, including laws enacted “for the express purpose of ‘protecting unborn lives.’” Id. (We assume the West Virginia legislature and the Fourth Circuit have equal concern for the health and wellbeing of pregnant women, but that concern is not mentioned in this opinion.) The court acknowledged that the presumption against preemption does not apply when a state regulates in an area where there has been “a history of significant federal presence.” Id. at *6. But here, the court reasoned that states have long regulated abortion under their traditional authority over health and safety and that federal regulation of prescription drugs is merely “incidental” and “tangential.” Id.
The court thus rejected both implied field preemption and implied conflict preemption. On field preemption, the court found that the laws operated in different fields: The state regulates abortion, including whether an abortion can be performed and under what circumstances. Federal law, on the other hand, regulates how mifepristone can be prescribed and dispensed. And even if the laws regulated the same field, it is not one that Congress has occupied.
On conflict preemption, the manufacturer argued that federal law has authorized the sale and use of mifepristone while state law has banned it. The Fourth Circuit, however, found this reasoning “flawed” because Congress did not intend to guarantee nationwide access to mifepristone through the FDA and REMS programs. Federal law merely established minimum safety rules in the event the drug is legally prescribed. Again, the Fourth Circuit faults the manufacturer for urging “a significant intrusion into a state’s traditional authority to protect the health and welfare of its citizens.” Id. at *8-*9. This is the first time ever, we believe, that a state ban against the use of an FDA-approved drug for its FDA-approved intended use has ever survived preemption.
We have several thoughts on this opinion, some of them covered in the dissenting opinion and others not. First and foremost, the Fourth Circuit emphasizes Dobbs and the rule of law, but what about Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013)? The Supreme Court held in Bartlett that the FDA’s regulation of prescription drugs impliedly preempted state-law design defect claims. More to the point, the Supreme Court also held that it is no answer to say that a manufacturer can comply with both state and federal law by simply not selling the drug. The West Virginia law places manufacturers in the same position—they can comply with the law by not selling the drug in West Virginia at all. Oddly, neither the majority opinion nor the dissent even mentions Bartlett.
Second, and as explained thoroughly in the dissenting opinion, the majority has not faithfully acknowledged the FDA’s role in regulating mifepristone and does not adequately explain away implied preemption. Federal law provides a comprehensive framework for accessing and using this product, yet West Virginia’s law criminalizes behavior that complies with federal requirements. That is neither “tangential” nor “incidental.” Contrary to the court’s conclusion, there is a history of “significant federal presence” in the regulation of prescription drugs. Moreover, when the majority finds that regulation of abortion and regulation of mifepristone occupy different fields, it is fair to ask whether the court is slicing the onion a bit too thin.
Third, the majority opinion (and the dissent) both trumpet that Dobbs returned the issue of abortion to the states. That is not what Dobbs held. The Supreme Court held in Dobbs that the constitution does not prohibit states from regulating abortion, subject to rational basis review, and that “authority to regulate abortion is returned to the people and their elected representatives.” Dobbs, at 259. So yes, the Supreme Court placed abortion in the hands of elected officials, but nowhere did it ordain that states would hold an exclusive position over federal lawmakers.
Fourth, and relatedly, the Fourth Circuit’s opinion rests squarely on states’ prerogative over health and safety, which is fine as far as it goes. But states’ authority over public health does not insulate them from federal requirements. It just so happens that the federal government has substantial authority over public health too, including and especially in connection with the sale and use of prescription drugs. Simply put, there is no “health” exception to the Supremacy Clause.
Finally, we cannot help but note the triumphant, even celebratory tone of this opinion. The author of the opinion is a true conservative, appointed by Ronald Reagan, and he has long expressed the view that Roe v. Wade was a judicial overreach and that issues such as abortion and gay marriage should not be constitutionalized. To make a point, he once wrote a concurring opinion describing abortion in graphic terms. He also is a respected jurist who just months ago published a resounding and expertly crafted rebuke of our current administration and its stunning disrespect for the judicial process. Hear, hear! All that being said, we formed the distinct impression in reading the opinion that these judges were taking a victory lap for “states’ rights.” Review the opinion for yourself, and see what you think.