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.
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.
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.”
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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