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Tuesday, June 18, 2024

Abortion Pills May Force States and the FDA Into a Standoff

Two weeks after the Dobbs decision that annulled the right to legal abortion across the US, it’s becoming clear that the availability of medication abortion—the early-pregnancy pill regimen that could offer a work-around—is not going to be as seamless as advocates hoped. Despite the White House and federal agencies promising unfettered access to the drugs, by mail if necessary, legal scholars are predicting court battles between states opposed to abortion and the US Food and Drug Administration—battles that, if they go badly, could undermine the FDA’s authority to regulate whole categories of drugs.

The hope for pill availability centers on a legal doctrine called preemption, which is based on the Supremacy Clause of the Constitution. That clause says that when federal and state laws come into conflict, federal law prevails—and that states can’t assume powers that already belong to the feds. In the case of medication abortion, the federal power is the FDA’s responsibility for ensuring that drugs are evaluated, via a predictable process, before being declared safe and effective. The conflict is the slew of proposals in multiple states—some already enacted and others under consideration—that would declare the abortion-pill regimen illegal in their jurisdictions, punching holes in the FDA’s nationwide approval.

Who will win this dispute isn’t clear. It’s widely accepted that FDA approval is the “floor” of drug regulation in the US: That is, a state can’t allow distribution of a pharmaceutical if the agency hasn’t approved it first. The fight is over whether FDA approval also represents a ceiling: whether a state can revoke availability of a drug that the agency judges legal and safe.

Medication abortion accounts for more than half of abortions in the US each year, so a decision on preemption could determine the future of a substantial portion of them. “There’s nothing that is expressly written in the FDA statutes that says FDA regulation of prescription drugs expressly preempts state efforts to regulate prescription drugs,” says Patricia J. Zettler, an associate professor at Ohio State University’s Moritz College of Law and coauthor of a February editorial in the New England Journal of Medicine that argues for preemption. “There are provisions in FDA statutes about over-the-counter drugs or about medical devices, but there’s nothing on prescription drugs. The question for the court is: Did Congress intend federal regulation in this space to displace state regulation?”

Depending on how it concludes, this face-off could have implications for drugs beyond the pharmaceutical combo that makes up medication abortion. Allowing a state to block drug access for political reasons could lead to bans on other drugs that members of a state legislature find objectionable: contraception, for instance, or the puberty-blocking hormones used in gender-affirming care.

Not only is there little statutory authority to help resolve this question, there’s also almost no prior case law. Scholars point to two potentially influential cases: a 2009 suit in which the Supreme Court agreed that a Vermont state law could mandate stronger side-effect label warnings than the FDA had required, and a 2014 case in which a district judge ruled that a Massachusetts governor did not have the power to ban a controversial but FDA-approved opioid.

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For medication abortions, sorting out federal preemption will require fresh lawsuits, which are likely to be brought in states already hostile to abortion, and—depending on their outcome—might rise to a Supreme Court that has already negated abortion rights. Legal experts worry that this could lead to findings with wider implications for federalism as a whole. “In over 230 years of Supreme Court jurisprudence, and the practice of law and rule of law, it has always been that federal laws and regulations govern the laws of our nation,” says Michele Bratcher Goodwin, a law professor and founding director of the Center for Biotechnology and Global Health Policy at the University of California, Irvine. “But there may very well be challenges to how we understand that rule of law, and what we’ve known for over 230 years may be chipped away.”

On the day of the Dobbs decision, President Joe Biden and Attorney General Merrick Garland separately stated that the federal government would protect pregnant people’s right to access the drugs that cause medication abortion: mifepristone and misoprostol. “We stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care,” Garland said. “The FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

To this point, though, there’s been no public commitment to action. Four days after the Dobbs ruling, Xavier Becerra, secretary of the Department of Health and Human Services, said in a media briefing that his team would work to increase access to medication abortion but told reporters to “stay tuned” when they asked for details.

It’s possible the Department of Justice could defend the FDA’s rights. Goodwin points out that the agency helped lead the fight against the Jim Crow laws of the early 20th century; she argued in The Atlantic in May that nullifying abortion access creates a “Jane Crow” regime that similarly infringes on constitutional rights. But those watching this issue evolve say the more likely scenario is that the drugs’ manufacturers will sue.

There is one such suit already: GenBioPro is suing Mississippi because the state’s restrictions go beyond those the FDA has set. That suit was brought before the Dobbs decision, though. Last week, the company and the defendant—Mississippi state health officer Thomas Dobbs, the Dobbs named in the Supreme Court decision—filed competing motions arguing whether the Dobbs ruling and the Mississippi trigger law that clicked into place immediately afterward invalidated the suit. GenBioPro’s lawyers asserted that their suit objecting to the state restrictions should go forward.

Whatever the outcome, that suit addresses only the law in Mississippi. To ensure broader distribution, a company would need a wider challenge. “A drug manufacturer that is materially affected by a ban could sue on a national or a state-by-state basis,” says Rachel Rebouché, an associate dean for research at Temple University’s James E. Beasley School of Law and one of the authors of a widely read law review article that argues there are precedents for preemption. A company could bring suit against a single state’s ban, she says, but it could ask the federal district court in that state to make its finding nationally applicable to any state where a similar ban exists.

What strengthens the preemption argument—the assertion that the FDA’s judgment has more power than state legislation—is that the abortion-pill regimen has been scrutinized by the agency in a way that few other drugs have been. Mifepristone, which causes a pregnancy to end by blocking a hormone that supports the uterine lining, isn’t simply a prescription drug. It is also subject to a rare form of extra control called a Risk Evaluation and Mitigation Strategy, which the FDA otherwise deploys only for drugs with serious side effects. (The imposition of this extra layer of regulation for mifepristone is widely taken to be a result of political pressure rather than pharmaceutical risk; mifepristone causes fewer adverse events than penicillin or Tylenol.) Both the prescribing clinician and the dispensing pharmacy must be separately certified by the FDA, and the recipient has to read through educational materials and then sign a “patient agreement form.”

“By creating an FDA, Congress said: This is how we get a nationally uniform market of safe and effective drugs.” Zettler says. “FDA has considered a wide variety of questions around this drug, and done the careful balancing that Congress asked it to do with respect to evaluating the safety and effectiveness of this drug, and come up with this scheme for regulating the drug. And the question will be: Can states deviate from that scheme?”

That question will be asked in a legal context in which a federal court in April overruled the power of the Centers for Disease Control and Prevention to set mask mandates, and in which the Supreme Court both invalidated a vaccine mandate set by the Occupational Safety and Health Administration and shifted the balance of the power to regulate emissions toward Congress and away from the Environmental Protection Agency. It’s a setting, in other words, in which the power of the federal government is being cut back. That leads inevitably to the question of how much the power of the FDA could also be reduced.

Preemption is an important issue to watch, Zettler says, because “it could limit the ways states can regulate other kinds of drugs that are not part of the abortion debate, or it could open the door to more state regulation. The effects outside the reproductive health care context could be important as well.”

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