Submissions from historians, legal scholars, economists, medical experts, state and local officials support FDA’s authority, oppose state interference with mifepristone access

Washington, D.C. – A broad and diverse range of organizations, experts, and scholars are asking the U.S. Court of Appeals for the Fourth Circuit to reverse a the lower court’s ruling in GenBioPro v. Raynes, which dismissed a challenge to West Virginia’s near-total abortion ban brought by the nation’s only generic manufacturer of mifepristone. More than a half-dozen amicus briefs in support of GenBioPro’s challenge were filed with the Court yesterday, outlining a wide variety of reasons that the Court of Appeals should allow GenBioPro’s challenge to the state’s ban to proceed.   

Amicus briefs in the case include those submitted by leading medical associations, legal historians, economists, scholars, and state and local officials. “Congress was clear about the specific regulatory structure that should govern mifepristone and it is the FDA, not West Virginia, that regulates the medication,” said Skye Perryman President and CEO of Democracy Forward and one of the counsel in the case. “The broad array of support for GenBioPro’s case underscores the matter’s significance not only for the people in West Virginia but for our overall democracy and regulatory system.” 

A brief summary of each amicus brief below, as well as links to each full brief. 

Leading Medical Societies– The American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the Society of Family Planning’s brief urges the Court to reverse the district court because the “overwhelming weight of scientific evidence and two decades of medical practice show that mifepristone is safe and effective.” These leading national medical societies further maintain that the “FDA’s determination that mifepristone should be broadly available is particularly appropriate because for many patients, pregnancy can be a serious or life-threatening condition.” Read the full National Medical Societies brief here. 

Food and Drug Law and Health Law Scholars – A group of legal scholars explains that the district court’s preemption analysis is flawed and should be reversed. According to the brief, the West Virginia abortion ban imposes “extreme burdens in accessing mifepristone that are not justified based on its safety and efficacy, contradicting a comprehensive federal regulatory scheme mandated by Congress.” Read the full FDA Scholars brief here. 

Legal Historians – A group of legal historians explains that the district court incorrectly upheld the West Virginia abortion ban under the theory that states have traditionally regulated the practice of medicine. This brief shows that the state abortion ban “prohibits medical professionals from even prescribing mifepristone unless one of the limited exceptions applies.  Because states have not traditionally regulated the drugs that doctors may prescribe, and the federal government has, the district court’s reasoning was flawed.” Read the full Legal Historian brief here. 

Doctors for America – Doctors for America (“DFA”) is an organization of over 27,000 physician and medical-student advocates from all 50 States and the District of Columbia, representing all areas of specialization. DFA’s brief notes that it “prides itself on its independence from the pharmaceutical industry,” which makes its filing of an amicus brief in support of a drug manufacturer, GenBioPro, “unusual.”  DFAs brief explains how allowing the West Virginia abortion ban to remain in effect “will set a dangerous precedent—one that would give all 50 States free rein to create their own politicized drug-access regimes, with disastrous results for the medical profession and millions of patients across the Nation.” Read the full Doctors for America brief here. 

City of Baltimore and Baltimore County, Maryland – Public Rights – Represented by the Public Rights Project, the City and County’s brief explains that West Virginia’s ban has “impacts across state lines.” The brief highlights how “providers and clinics in Maryland have seen a significant surge in patient demand from West Virginia residents, burdening health care delivery systems in our state and impairing our ability to meet the new demand as well as the needs of our own residents.” Read the full Public Rights brief here. 

Economic Scholars– A group of distinguished economists who research the impact of abortion restrictions explain in their brief that the research “conclusively shows how West Virginia’s abortion laws impede access to abortion care, including patients’ access to mifepristone.”  The brief goes on to explain that “bans on telemedicine and medication abortion such as those in effect in West Virginia… force patients to undertake significant travel and visit clinics in person—and thus hinder their access to care.” Read the full Economists brief here. 

State of North Carolina – North Carolina Attorney General Stein filed an amicus brief that explains to the Court that “the text of the federal law at issue, 21 U.S.C. § 355-1, together with well-established obstacle-preemption principles, shows that States do not have free rein to restrict patient access to mifepristone.” Read the full State of North Carolina brief here. 

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Democracy Forward is a national legal organization that is dedicated to the advancement of democracy and social progress. Democracy Forward, along with co-counsel, represents GenBioPro, the manufacturer of generic mifepristone in a lawsuit to reverse West Virginia’s restrictions that limit access to the medication. 

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