No backdoor abortion mandate

On Tuesday, the Fourth Circuit refused an invitation to mandate access to chemical abortion drugs nationwide. In GenBioPro v. Raynes, the court held that the Food and Drug Administration’s (FDA) regulation of mifepristone—the first drug in the chemical abortion regimen—does not preempt West Virginia’s democratically enacted law protecting unborn children. The court refused “to once again federalize the issue of abortion without a clear directive from Congress, right on the heels of Dobbs.”

After the Supreme Court “return[ed] the issue of abortion to the people’s elected representatives” in Dobbs v. Jackson Women’s Health Organization, West Virginia enacted a law prohibiting abortion except in cases involving non-viable pregnancies, ectopic pregnancies, medical emergencies, rape, or incest. GenBioPro, the manufacturer of generic mifepristone, filed suit in federal court arguing that the FDA’s approval and regulation of mifepristone preempts West Virginia’s pro-life law.

GenBioPro’s preemption argument centered on a 2007 Amendment to the Food Drug and Cosmetic Act. That amendment known as the FDAAA enhanced the FDA’s regulatory authority over high-risk drugs. Under the FDAAA, the FDA may require a drug manufacturer to develop and implement a Risk Evaluation and Mitigation Strategy or REMS. When a drug is especially high-risk, like mifepristone, and has been known to cause serious adverse events, the FDA may require additional “elements as are necessary to assure safe use.” Such safe-use elements include limiting the dispensing of these high-risk drugs to certain health-care settings or mandating patient monitoring.

Mifepristone, for instance, contains a black box warning providing that serious infections and even death may result. According to the FDA’s own label, approximately one in 25 women who use the abortion drug end up in the emergency room.

GenBioPro seized on language in the 2007 Amendment stating that the elements to ensure safe use imposed by the FDA should “not be unduly burdensome on patient access to the drug.” According to GenBioPro, that language silently federalized abortion, requiring access to the abortion drug in all 50 states, irrespective of any state’s pro-life law. Ironically, GenBioPro argued that because mifepristone was especially dangerous and needed additional safeguards, that meant that West Virginia was powerless to protect women or unborn life from the drug.

The Fourth Circuit disagreed. The Court began by noting that states have long exercised their police powers to protect the health and safety of their citizens. In areas of such traditional state regulation, the court assumes that federal law does not supplant state law, unless Congress clearly says so. This presumption means that courts do not read federal law to override state law unless Congress unmistakably provides for preemption.

The Fourth Circuit refused to find a nationwide abortion mandate in a statute that does not so much as mention the procedure. It firmly rejected the notion that Congress intended to guarantee nationwide access to mifepristone when it enacted the 2007 amendments. To the contrary, Congress has never created a federal right of access to any drug since doing so would constitute a significant intrusion into state sovereignty: “To read an access mandate into the FDAAA would be to radically redefine the FDA’s historic role and authorize an unprecedented federal intrusion into the regulation of medical practice—an area long reserved to the states.” The Court also explained that the Food Drug and Cosmetic Act sets a federal floor, not a federal ceiling. This means that states may complement federal law regulating drugs like mifepristone with additional state regulation.

GenBioPro’s theory of preemption was sweeping. Under the drug manufacturer’s preemption theory, the states would be powerless to regulate the highest-risk drugs on the market. GenBioPro’s theory would preempt state laws regulating everything from opioids to mifepristone. Many states, for example, limit the maximum daily dose or duration for certain opioid prescriptions. Finding them to be preempted could cause real harm to real people.

The Fourth Circuit’s decision throws cold water on the abortion drug manufacturer’s efforts to judicially resurrect a nationwide abortion access mandate via the backdoor of preemption. If federal courts could nullify state abortion laws just because the FDA has regulated the high-risk drug, the promise of Dobbs would be illusory. Thankfully, the Fourth Circuit rightly held that Congress did not impose a nationwide abortion mandate in a statute that says nothing about abortion.