Two New Lawsuits Challenge State Restrictions on Abortion Pill Access, Arguing Federal Law Preempts

Two New Lawsuits Challenge State Restrictions on Abortion Pill Access, Arguing Federal Law Preempts State Laws
1/25/2023 by Carrie N. Baker



Medication abortion uses two FDA-approved oral medications to end a pregnancy: mifepristone and misoprostol, commonly referred to as “abortion pills.” On Jan. 3, FDA announced a new certification process for brick-and-mortar pharmacies to become eligible to sell the abortion pill mifepristone for the first time. (Charles McQuillan / Getty Images)

On Jan. 25, reproductive health advocates filed two federal lawsuits—one in North Carolina and another in West Virginia—challenging state laws imposing medically unnecessary restrictions on physicians prescribing the abortion pill mifepristone to their patients. Both cases argue that state laws are preempted by U.S. Food and Drug Administration (FDA) rules allowing telemedicine abortion and mailing of mifepristone.

North Carolina
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Dr. Amy Bryant. (UNC)

North Carolina requires doctors to dispense the abortion pill mifepristone in-person in a specially certified surgical facility after state-mandated counseling and a mandatory 72-hour delay. These requirements directly contradict federal standards for distribution of mifepristone, which is safer than Tylenol. “As a physician, my number one priority is the health and well-being of my patients,” said Dr. Amy Bryant, plaintiff in the case. “We know from years of research and use that medication abortion is safe and effective. There’s no medical reason for politicians to interfere or restrict access to it, or for states to force doctors to comply with mandates not supported by medicine or science. These burdensome restrictions on medication abortion force physicians to deal with unnecessary restrictions on patient care and on the healthcare system.”
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“Congress has made clear that FDA is tasked with establishing regulatory controls for this drug to ensure safety and patient access in the least burdensome way,” said Eva Temkin of King & Spalding, who filed the lawsuit. “State politicians cannot stand in the shoes of the FDA to impose restrictions on medication access that FDA has determined are not appropriate and that upset the careful balance FDA was directed by Congress to strike.” Legal experts argue that the Constitution’s 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. The Biden administration agrees. In June, after the U.S. Supreme Court overturned the constitutional right to abortion, U.S. Attorney General Merrick Garland said, “States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
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“Restricting access to an FDA-approved medication is unprecedented and an alarming intrusion into patient access to medicine in this country,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project (EMAA Project), which advocates for increased access to abortion pills. “The courts must act now to safeguard health care providers’ ability to provide safe and effective care for their patients.”


Dr. Franz Theard prepares doses of mifepristone at the Women’s Reproductive Clinic in Santa Teresa, N.M., on May 7, 2022. The clinic is a major provider of abortion pills to women from Texas, where abortion is outlawed. (Paul Ratje / The Washington Post via Getty Images)

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“States cannot substitute their medical and scientific judgments for judgments FDA has made, and doing so undermines not only access to medication, but the country’s entire drug regulation system.”

https://msmagazine.com/2023/01/25/lawsuits-state-law-abortion-pill-federal-fda/