Abortion pill lawsuit won’t get a fair shake post-Roe

The first significant stage of post-Roe abortion litigation focuses heavily on abortion pills. GenBioPro, a pharmaceutical company that makes mifepristone, has asked a federal court to declare that West Virginia’s anti-abortion law is inconsistent with the Federal Drug Administration’s determination that the pill is safe and effective. If the lawsuit succeeds, states would not be able to criminalize abortions that rely on medication.

Mifepristone is FDA-approved only for abortions through the 10th week of pregnancy. People seeking the medication would still have to find prescribers, and pharmacies would still need to apply for a special certification to dispense it. Yet the fact that pills can be prescribed by telemedicine, mailed to patients and taken at home would still provide some measure of freedom to women in states that ban abortion.

Under a Republican administration, the FDA might come under pressure to restrict or repeal approval for mifepristone. A policy shift at the administrative agency level would, however, still have to go through judicial review.

Nothing would make me happier than to tell you the drug company’s suit will win and that the appellate courts and the U.S. Supreme Court will confirm that victory. Certainly, the legal concept known as federal preemption would dictate that states should not be able to block the sale of an FDA-approved drug.

The reality, however, is more complicated — and more depressing. Having just granted a historic victory to the anti-abortion movement in the Dobbs decision, the court’s conservative majority seems unlikely to be in the mood to undercut the states’ authority to ban abortion. I expect the lower courts — and eventually the justices — to cook up a new theory that allows states to ban mifepristone.

The idea behind federal preemption is that, under the Constitution, federal law is the supreme law of the land. When Congress is authorized to act, states cannot contravene the laws it passes. In a conflict between state and federal law, the federal one is supposed to prevail.

Under the federal law that governs drug approvals by the FDA, the business of regulating pharmaceuticals belongs to the federal government. If West Virginia set up its own food and drug administration, it would lack the power either to authorize or prohibit the medical use of pharmaceuticals that the federal FDA had chosen to regulate.

Federal preemption in areas of regulation also makes good economic sense. It would be difficult to run a national economy if the pharmaceutical industry and others like it had to go through drug approvals for each state and another for the federal government.

One federal case raising a somewhat analogous issue is from 2014. Massachusetts, citing the opioid crisis, adopted a set of regulations making it harder for patients to get an opioid called Zohydro. The regulations required the pharmacist to assess potential patients; prohibited anyone other than a licensed pharmacist from handling the drug; and required warnings when counseling patients about the dangers of addiction. Zogenix, the company that manufactured Zohydro, sued.

A federal district court judge, Rya Zobel, held correctly that federal law preempted Massachusetts from issuing its regulations. As she explained, a state like Massachusetts has the authority to “regulate the administration of drugs by the health professions.” But a state “may not exercise those powers in a way that is inconsistent with federal law.” She accepted the company’s argument that Massachusetts was “trying to make scarce or unavailable” a drug approved by the FDA.

Applied to mifepristone, the Zogenix decision would lead to the conclusion that West Virginia can’t regulate the drug beyond what the FDA requires. But a decision from the Massachusetts federal district court doesn’t bind courts outside of Massachusetts.

We can expect conservative judges to side with West Virginia, not GenBioPro.

The most straightforward way for a conservative court to do so would be to hold that West Virginia’s abortion ban isn’t imposing extra safety restrictions on mifepristone. Such a court might say that such abortion bans don’t target federally approved drugs but prohibit a specific action, namely abortion, that can be accomplished in various ways — including by using mifepristone.

The obvious counterargument is that the FDA has specifically approved mifepristone for the purpose of abortions, so its regulatory judgment should be final under federal law. But if conservative judges — and five conservative justices — want to reach the opposite conclusion, they will.