Does the FDA get final say on abortion?
A new court case from West Virginia intends to upend Dobbs
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GenBioPro, a drug company whose only product is the generic version of mifepristone, the chemical abortion drug, has filed suit in federal court in West Virginia arguing that the FDA’s approval of its drug means that no state may regulate or prohibit chemical abortion. If GenBioPro were to prevail, the case would result in a federal elective abortion mandate. On the merits, GenBioPro’s case is weak, but it nevertheless represents a grave threat to state pro-life laws.
After the Supreme Court overturned Roe v. Wade, the West Virginia legislature enacted the Unborn Child Protection Act, which prohibits abortions except in circumstances involving medical emergency, rape, incest, or a nonviable child. GenBioPro makes the audacious claim that West Virginia’s law is invalid because federal law “delegates to FDA exclusive authority” to decide whether chemical abortion should be permitted nationwide.
GenBioPro’s claim arises from a legal doctrine known as preemption. Under the Supremacy Clause of the United States Constitution, when state and federal law conflict, the federal law governs, and the state law must give way. The touchstone of the legal analysis is always congressional intent. Sometimes Congress will expressly preempt state law—as it has with nuclear power safety standards and with medical devices regulated by the FDA. In other, more limited circumstances, the Supreme Court has found implied preemption where state law frustrates and conflicts with a federal purpose.
GenBioPro’s preemption claim fails because the drug company cannot point to any evidence that Congress ever mandated nationwide abortion access or delegated to the FDA the authority to do so. The statute that governs the FDA—the Food, Drug, and Cosmetic Act (FDCA)—does not even mention abortion. Nor has it ever been interpreted to require nationwide access to any drug, much less one that is inherently dangerous to women and causes the death of an unborn child.
In fact, because chemical abortion is dangerous and associated with serious adverse events like hospitalization and death, it is subject to greater federal restrictions than other drugs. Mifepristone’s current medication guide, for instance, acknowledges that between 2.9 percent and 4.6 percent of women who use the drug will end up in the emergency room. Because of these risks, Congress required the FDA to put additional restrictions, called REMS, on the drug’s distribution and use.
GenBioPro creatively claims that because Congress told the FDA not to unduly burden patient access when the FDA itself crafted REMS, the states cannot exercise their long-held prerogative to regulate for health and safety. GenBioPro is wrong. It is simply not the case that the more dangerous a drug is, the less ability a state has to protect its citizens. To win on this claim, GenBioPro would need to overcome a presumption that Congress does not cavalierly preempt state law in areas like public health, an area traditionally regulated by the states. Yet the FDCA has long been interpreted as providing a minimal federal safety floor for drug approvals while allowing states to impose additional regulations and restrictions on those drugs. Further, through many amendments to the FDCA, Congress has taken care to preserve parallel state laws that also protect public health.
GenBioPro’s contrary argument is so aggressive that even the Biden administration—an administration that has been upfront about its post-Dobbs desire to require nationwide abortion access regardless of where women live—has failed to support the company in the case. Even in the face of President Joe Biden’s directive to the FDA to ensure that abortion drugs are as widely accessible as possible, the FDA has never argued that the FDCA preempts state abortion restrictions and regulations. Instead, the agency has long acknowledged that providers must comply with state laws in addition to the FDA’s REMS restrictions. For example, while its REMS requirements allow non-doctors to prescribe mifepristone, health care providers are instructed to check “individual state laws” to determine whether they are allowed to prescribe mifepristone in their jurisdiction.
GenBioPro’s arguments would destroy the promise of Dobbs. That decision finally returned to the people and their elected representatives the power to protect unborn life and maternal health. Yet according to GenBioPro, the desire of state legislatures to protect life is meaningless because the FDA approved the chemical abortion drug. Yet no one thought Dobbs was of little consequence because the FDA had already decided chemical abortion should be legal in every state. And for good reason. There is zero evidence that Congress delegated to an agency the power to decide whether unborn children have the most basic of rights: the right to life.
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