RICHMOND, Virginia – The nation’s only generic maker of mifepristone has filed a federal appellate brief claiming West Virginia’s near-total abortion ban is preempted by federal law and should be struck down.
GenBioPro filed the brief February 7 with the U.S. Fourth Circuit Court of Appeals 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.
The law 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.
“Under the U.S. Constitution, federal law is the supreme law of the land,” GenBioPro counsel David Frederick of Kellogg Hansen said. “Congress has made clear that, for mifepristone, FDA must protect access for patients. The law does not allow states to limit the drug’s availability.
“West Virginia’s attempt to burden access to mifepristone violates the Constitution’s mandate that federal law take precedence when in conflict with state law.”
Last week, the company 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.
“Decades of science and evidence have made clear that mifepristone is safe,” said Skye Perryman, president and CEO of Democracy Forward, which also is representing GenBioPro. “West Virginia’s near-total abortion ban is a dubious effort by extremists to substitute political ideology for the scientific expertise of FDA.
“West Virginia’s near-total ban on abortion is unlawful and harmful to patients in need of essential, evidence-based medication and medical care.”
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 spent nearly a decade developing the generic version of mifepristone, and by seizing the authority Congress clearly gave the FDA to regulate the medication, West Virginia’s near-total abortion ban would unavoidably and unlawfully harm not just GenBioPro but people who rely on its medication in West Virginia,” Daphne O’Connor of Arnold & Porter, another attorney representing the company, said.
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)
