RICHMOND, Virginia – Several healthcare experts have filed briefs supporting a drug manufacturer’s federal appeal challenging West Virginia’s near-total ban on abortion.
The amicus briefs were filed February 14 asking the Fourth Circuit U.S. Court of Appeals to reverse a district court ruling that dismissed GenBioPro’s challenge to the state’s Unborn Child Protection Act. GenBioPro filed its appellate brief with the court last week arguing the post-Dobbs ban is in direct conflict with federal law.
“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, which is representing GenBioPro 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.”
GenBioPro filed its appeal brief February 7 asking the Fourth Circuit asking it to reverse what it calls the state’s “extremist” Unborn Child Protection Act that came in the wake of the U.S. Supreme Court’s Dobbs ruling, which overturned Roe v. Wade.
West Virginia’s Unborn Child Protection Act bans abortions in almost all cases at any stage of pregnancy and makes it a felony for anyone other than physicians to sell, prescribe or dispense mifepristone outside of the act’s narrow exceptions.
GenBioPro, the nation’s only generic manufacturer of mifepristone, says only the Food and Drug Administration may regulate access to the drug.
The seven amicus, or friend of the court, briefs were filed by medical associations, legal historians, economists, scholars and state and local officials. They support FDA authority and oppose state interference regarding access to mifepristone, the generic drug. They also are the first time many of these medical associations have weighed in on an abortion case based on the preemption argument.
In a brief filed by the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and the Society of Family Planning, the groups urge 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.” They also say 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.”
In another brief filed by legal scholars, they say the district court’s preemption analysis is flawed and should be reversed, arguing West Virginia’s 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.”
A brief by a group of legal historians says the district court incorrectly upheld the abortion ban under the theory that states have traditionally regulated the practice of medicine. This brief says the 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.”
Doctors for America, a group of more than 27,000 physician and medical-student advocates representing all areas of specialization, filed a brief stating the abortion ban “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.” The DFA brief also notes that it “prides itself on its independence from the pharmaceutical industry,” saying its support of GenBioPro is “unusual.”
A brief filed by the Public Rights Project on behalf of the City of Baltimore and Baltimore County Maryland, says the West Virginia ban has “impacts across state lines” and says “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.”
A group of economists filed a brief saying its research “conclusively shows how West Virginia’s abortion laws impede access to abortion care, including patients’ access to mifepristone.” It also says “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.”
North Carolina Attorney General and Democratic gubernatorial candidate Josh Stein filed a brief saying the federal law at issue “together with well-established obstacle-preemption principles, shows that states do not have free rein to restrict patient access to mifepristone.”
Earlier this month, GenBioPro filed an amicus brief with the U.S. Supreme Court asking it to reverse a Fifth Circuit ruling from last year that would force the FDA to reinstate conditions on the use of mifepristone that existed before 2016.
The company says it products about two thirds of all mifepristone sold in the United States, and it has held FDA approval for the generic version since 2019. Medical abortion using the two-drug regimen involving mifepristone early in pregnancy – with another drug called misoprostol – is the most common and preferred form of abortion care in the United States, accounting for more than half of all pregnancy terminations.
GenBioPro’s appeal was filed November 9, just three days after U.S. District Judge Robert C. “Chuck” Chambers had entered a final dismissal order in the case it had filed regarding its generic mifepristone abortion pill. Chambers’ order dismissed the final count in GenBioPro’s challenge to West Virginia medication abortion ban and restrictions.
The company appealed Chambers’ dismissal of its challenge that the state’s Unborn Child Protection Act is preempted because it conflicts with the U.S. Food and Drug Administration decision to approve and regulate mifepristone for medication abortion. The challenge also asserts that this law and some state telehealth laws are unconstitutional.
Chambers said the U.S. Supreme Court’s Dobbs decision makes it clear the regulation of abortion falls on the states, and that West Virginia was regulating health care, not the company itself, in the Unborn Child Protection Act.
West Virginia Attorney General Patrick Morrisey’s office won an earlier partial dismissal in August when Chambers ruled West Virginia’s Unborn Child Protection Act was not preempted by federal law and dismissed all other claims except the preemption attack on the telehealth provisions.
“The new Unborn Child Protection Act is not preempted by federal law and all of these statutes are constitutional – that is our position, and the judge agreed with us,” Morrisey told The West Virginia Record. “We stand ready to continue defending West Virginia law to the fullest.”
The FDA has relaxed restrictions on the medication. During the COVID-19 pandemic, it allowed patients to receive the pill by mail. And last year, the FDA approved retail pharmacy dispensing of the drug with a certificate.
West Virginia’s law bans most abortions. There are exceptions for rape and incest victims as well as in cases of life-threatening medical emergencies and nonviable pregnancies.
GenBioPro is being represented in the Fourth Circuit by Kellogg Hansen Todd Figel & Frederick, Democracy Forward and Arnold & Porter Kaye Scholer.
U.S. Court of Appeals for the Fourth Circuit case number 23-2194 (U.S. District Court for the Southern District of West Virginia case number 3:23-cv-00058)