Federal Judge Rules Some State Restrictions on Abortion Pills Are Unlawful, Allows Others

Update Wednesday, May 1, at 9:15 a.m. PT: A federal judge in North Carolina ruled on April 30 that some of the state restrictions placed on dispensing abortion pills beyond the controls set by federal regulators are unlawful. The ruling is a partial victory for Dr. Amy Bryant, the physician who brought the lawsuit. Bryant said was pleased that the decision lifted some restrictions “that second-guess or interfere with the FDA’s expert judgment.” The court, however, allowed some restrictions not specifically addressed in FDA regulations on mifepristone to continue

The Court summarized its decision as follows:

“The Court finds and concludes that to the extent North Carolina law imposes safety restrictions on the distribution of the drug that the FDA has implemented and then later affirmatively rejected and removed, those laws frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution that do not create unnecessary burdens on the health care system or patient access. The provisions of the North Carolina law that prohibit health care providers other than physicians from prescribing the drug, require in-person prescribing, dispensing, and administering, mandate the scheduling of an in-person follow-up appointment, and require non-fatal adverse event reporting to the FDA stand as obstacles to Congress’ purpose and are preempted. 

But to the extent North Carolina law imposes requirements that have not been expressly considered and rejected by the FDA or that focus more on the practice of medicine and a patient’s informed consent, these provisions do not interfere with Congress’ purpose and are not preempted. This includes the state’s requirements for an in-person advance consultation, use of an ultrasound, an in-person examination, blood type testing, and adverse event reporting to state health authorities.”

The ruling could have larger implications for providing care, based on FDA guidelines, and may provide additional legal avenues for challenging abortion bans in court.

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

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.

Dr. Amy Bryant

North Carolina doctor Amy Bryant filed a lawsuit in federal court challenging state laws imposing medically unnecessary restrictions on physicians prescribing the abortion pill mifepristone to their patients.

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.”

In December of 2021, the FDA removed in-person dispensing requirements for the medication and recently allowed certified pharmacies to dispense the medication. CVS and Walgreens recently announced they are applying for certification to stock and dispense mifepristone.

Close to half of states now allow clinicians to prescribe abortion pills by telemedicine and mail, but eighteen states have laws requiring the prescribing clinician to be in the physical presence of the patient when dispensing the mifepristone, which blocks telehealth treatment.

“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.”

Reproductive health advocates have been working for years to loosen FDA restrictions on mifepristone, only to face political motivated state restrictions on the medication.

“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)

West Virginia

A second lawsuit challenging state restrictions on abortion pills was filed by GenBioPro, which received FDA approval to market the first generic version of mifepristone in 2019. The company seeks to block West Virginia’s ban on abortion and associated restrictions that limit access to the medication.

The suit, filed in federal court, alleges that a state abortion ban passed in the aftermath of Dobbs and other restrictions on medication abortion violate the Supremacy Clause and the Commerce Clause of the US Constitution.

“Congress subjected [mifepristone] to a substantial and detailed federal regulatory program with which West Virginia law interferes. That state law must give way to the comprehensive federal regime Congress enacted and the Food and Drug Administration implemented,” the complaint states. “West Virginia’s ban and restrictions “impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the State.”

Mifepristone is used together with another medication, misoprostol, to end pregnancy in the first trimester. In 2020, more than half of all pregnancy terminations in the U.S. occurred with abortion pills.

“Laws like the ones in effect in West Virginia are harmful and unlawful,” said Skye Perryman, president and CEO of Democracy Forward, who is also serving as counsel for the company along with the law firm Kellogg Hansen. “Our case makes clear that nothing in the Court’s decision last year in Dobbs displaced Congress and FDA’s role in deciding whether medications are safe and effective and determining which regulations should be imposed on mifepristone.”

“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.”

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Carrie N. Baker, J.D., Ph.D., is the Sylvia Dlugasch Bauman professor of American Studies and the chair of 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 cbaker@msmagazine.com or follow her on Twitter @CarrieNBaker.