Abortion pill lawsuit won’t get fair shake

by Noah Feldman

The first significant stage of post-Roe abortion litigation is underway and focuses heavily on abortion pills. GenBioPro, a pharmaceutical company that makes the drug 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 medical abortions — terminations that rely on medication rather than a procedure.

From the standpoint of abortion-rights advocates, a ruling that uses federal law to protect medical abortion would not be as good as restoring Roe v. Wade. But it might be the next best thing. Medical abortion accounts for more than half the terminations in the U.S.

To be sure, mifepristone is approved by the FDA 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 even repeal approval for mifepristone. A shift in policy at the administrative agency level would, however, still have to go through judicial review to prove it was based on reason and not arbitrary.

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 a drug approved by the FDA.

The reality, however, is more complicated — and more depressing. Having just granted an epochal, 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 within their borders despite the FDA’s licensing.

To see how that might be done, you have to start with the way the case really should come out legally — and would, if it weren’t about medication connected to the abortion issue.

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, there is no question that the business of regulating pharmaceuticals belongs to the federal government, not the states. If West Virginia set up its own state-level 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.

Apart from the logic of formal constitutional law, you can also see why federal preemption in areas of regulation 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 51 times — one for each state and another for the federal government. (In the case of vehicle emissions, where California has demanded more rigorous standards than those required by the federal government, Congress had to pass special legislation to allow the deviation.)

The 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, however well-meaning they were. 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. That would, logically, mean that West Virginia and other states that impose extra regulatory restrictions on the administration of mifepristone may not do so.

But a decision from the Massachusetts federal district court doesn’t bind any courts outside of Massachusetts.

We can expect conservative judges, whether at the district, appellate, or Supreme Court level 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. Indeed, a conservative court might say that such abortion bans don’t target federally approved drugs at all. Instead, they prohibit a specific action, namely abortion, that can be accomplished in various ways — including by using mifepristone. Thus, even if the conservative court disqualified state regulations that make mifepristone difficult to get — for example, for patients who need it to treat a miscarriage — it could still hold that the state could make it illegal to obtain or use the drug for an abortion.

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.

Noah Feldman is a Bloomberg Opinion columnist and a professor of law at Harvard University.