FDA Abortion Pill Policy May Preempt State Restrictions, Say Legal Scholars: ‘We Need to Push the Boundaries and See What Sticks’

Legal scholars and advocates are questioning the constitutionality of state-level restrictions on abortion pills.

Update June 24, 2022, 10:53 a.m. PT: After the U.S. Supreme Court overturned Roe v. Wade, Attorney General Merrick Garland issued a statement saying states cannot ban abortion pills on federal preemption grounds. “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,” said Garland.

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Mifepristone is used in combination with another medication—misoprostol—to safely and effectively end early pregnancy. (Robin Marty / Flickr)

In December of 2021, the FDA lifted some of its burdensome restrictions on the abortion pill mifepristone, including the requirement that healthcare providers must meet in-person with patients to dispense the medication. Nineteen states, however, continue to impose in-person dispensing requirements and many impose other restrictions that go beyond FDA requirements, like only allowing physicians to dispense the medication and requiring multiple in-person visits to obtain the medication. In October, Texas banned clinicians from prescribing abortion pills after seven weeks of pregnancy—three weeks before the current FDA time limit of 10 weeks. Legal scholars and advocates are questioning the constitutionality of these additional restrictions on abortion pills.

University of Pittsburgh law professor Greer Donley argues that state bans of an FDA-approved abortion medication may violate the supremacy clause of the U.S. Constitution. The supremacy clause establishes that federal laws take precedence over state laws that are in conflict, and prohibits states from interfering with matters that are exclusively entrusted to the federal government—such as the regulation of medications.

“To get an FDA approval for a drug, it can take decades and can cost hundreds of millions of dollars to produce the amount of research and data that’s required,” said Greer. “That comes with a license to sell the product in 50 states. If states could just ban different types of products that are FDA approved, you can imagine that pharmaceutical companies would be quite upset about that because that is really curtailing their market for their product, which they worked so hard to be able to sell.”

Professor Greer cited a 2014 case where the Massachusetts governor issued an emergency order banning the prescribing and dispensing of the FDA-approved opioid Zohydro. The producer of the drug sued in federal court and the court ruled that the emergency order was preempted by federal law under the supremacy clause. The court blocked the order and allowed sale of the drug. The court ruled that allowing the law to stand would “undermine the FDA’s ability to make drugs available to promote and protect the public health.”

A similar lawsuit has already been filed by GenBioPro, which produces a generic form of the abortion pill mifepristone. The company has sued the state of Mississippi in federal court, challenging state restrictions that go beyond the FDA rule, including a law allowing only physicians to dispense the drug and requiring in-person dispensing. That suit is currently pending.

“It gets a little bit more complicated when we start thinking about the post-Roe world and abortion bans. I think if a state were to pass a law that specifically banned mifepristone or misoprostol that would be preempted,” said Greer. “But I think it’s a really hard question about whether or not a state’s general abortion ban is preempted. There are some counterarguments as to why that is different than a state banning an FDA-approved drug. But still, we think that there are arguments to suggest a state cannot do that. And if that were to be successful, then theoretically, it would mean it would create an exception to a state abortion ban for medication abortion. That would say you have to allow the sale and use of medication abortion, which would mean abortion through 10 weeks that is done with pills.”

If states could just ban different types of products that are FDA approved, you can imagine that pharmaceutical companies would be quite upset about that because that is really curtailing their market for their product, which they worked so hard to be able to sell.

University of Pittsburgh law professor Greer Donley

Temple University law professor Rachel Rebouché agrees.

“There’s an argument to be made that since mifepristone is only approved to terminate a pregnancy, if you ban it, then effectively you’re taking that drug off the market,” said Rebouché. “The FDA is the agency charged with enacting a uniform drug policy that protects safety and allows drugs into the market, but states are usurping the power of the FDA to make those decisions.”

While many federal judges are hostile to abortion rights, Greer sees some hope.

“Something that’s interesting about this case is that conservative justices are often the ones that support preemption,” said Greer. “If you look at the major, recent Supreme Court cases that have considered FDA law in the context of preemption, you have conservatives that are often the ones that are promoting the idea because it supports pharmaceutical companies and business.”

Rebouché believes it would help if the FDA would explicitly state their intent to preempt state regulation of mifepristone.

“We’ve been urging the Biden administration to have the FDA say, ‘after decades of research and careful consideration, and with a conservative approach, we have regulated mifepristone. We’ve decided how it should be dispensed and in what circumstances, and states should not contradict that policy.’”

Since mifepristone is only approved to terminate a pregnancy, if you ban it, then effectively you’re taking that drug off the market.

Temple University law professor Rachel Rebouché

While Greer warns that politics could influence a judge’s consideration of this issue, she supports this strategy.

“Abortion exceptionalism exists. The court could easily come up with reasons to say that this is different. It is a really unique case. But at the same time, the anti-abortion movement has tried a lot of stuff. Sometimes it works and sometimes it doesn’t. I think the abortion rights movement needs to take on that strategy. We need to try a lot of new things. We need to be creative. We need to push the boundaries and see what sticks.”

Sign and share Ms.’s relaunched “We Have Had Abortions” petition—whether you yourself have had an abortion, or simply stand in solidarity with those who have—to let the Supreme Court, Congress and the White House know: We will not give up the right to safe, legal, accessible abortion.

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About

Carrie N. Baker, J.D., Ph.D., is the Sylvia Dlugasch Bauman professor in the Program for the Study of Women and Gender at Smith College. She is a contributing editor at Ms. magazine. You can contact Dr. Baker at [email protected] or follow her on Twitter @CarrieNBaker.