If successful, GenBioPro’s lawsuit could stop states from banning mifepristone, an essential abortion medication.
GenBioPro—the nation’s only generic manufacturer of the abortion pill mifepriston—appealed last week the dismissal of a federal lawsuit challenging a West Virginia abortion ban that restricts access to the FDA-approved abortion medication mifepristone.
In the lawsuit filed Nov. 9, GenBioPro argued that the West Virginia law conflicts with federal law and therefore violates the Supremacy Clause of the U.S. Constitution, which says federal laws take precedence over conflicting state laws. GenBioPro also argued the ban violates the Constitution’s Commerce Clause, which gives Congress broad powers to regulate interstate commerce and restricts states from impairing interstate commerce.
Shortly after the Supreme Court reversed Roe v. Wade in June 2022, West Virginia banned abortion in almost all circumstances, in effect banning the sale of mifepristone in the state.
“Today’s appeal is a critical next step in our fight to protect access to medication abortion,” said Skye Perryman, p resident and CEO of Democracy Forward, who is also serving as counsel for the company. “West Virginia’s decision to step in where Congress has granted FDA the authority to regulate mifepristone is unlawful and could undermine not only access to medication, but the country’s entire drug regulation system.”
The U.S. Food and Drug Administration approved GenBioPro’s generic version of mifepristone in 2019, which now makes up a majority of the market for mifepristone in the United States. Shortly after the Supreme Court reversed Roe v. Wade in June 2022, West Virginia banned abortion in almost all circumstances, in effect banning the sale of mifepristone in the state.
“Decades of science support mifepristone’s safety and efficacy and it is unacceptable that people living in West Virginia who need this basic healthcare are being forced to travel out of state or forgo care altogether,” said Perryman. “This is an example of extremists seeking to replace their own political judgments for the scientific judgments of the FDA.”
In their initial complaint, GenBioPro detailed their challenge to West Virginia’s abortion pill ban:
“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. 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 blocks the pregnancy-sustaining hormone progesterone, which “loosens” pregnancy tissue from the uterine wall. Then misoprostol, taken 24-48 hours later, causes uterine contractions to expel pregnancy tissue. Used in combination, these medications are 98 percent effective in the first 12 weeks of pregnancy and safer than Tylenol. In 2020, more than half of all pregnancy terminations in the U.S. occurred with abortion pills.
If successful, GenBioPro’s lawsuit could prevent states from banning mifepristone and could also protect access to other FDA-approved medications that have significant health benefits, such as vaccines, which have become the target of a growing anti-vaccine political movement.
Judge Rules Federal Law Preempts Telemedicine Abortion Ban
In another part of the August decision, Judge Chambers ruled that a West Virginia law restricting doctors from prescribing mifepristone via telemedicine was “unambiguously preempted” by FDA regulation of mifepristone because Congress had allocated to the FDA alone the right to dictate the manner in which mifepristone may be prescribed.
In December 2021, the FDA removed in-person dispensing requirements for mifepristone. Chambers wrote that the conflict between the FDA rule allowing telemedicine abortion and the state law prohibiting it created a direct conflict.
Congress has been clear that it is the FDA that regulates medications in this country.Skye Perryman, Democracy Forward
Nineteen states have laws that require prescribing clinicians to be in the physical presence of patients when dispensing mifepristone—a requirement that blocks telehealth abortion, an increasingly important avenue for accessing abortion pills.
The West Virginia court’s ruling could be helpful to people in states that still allow some abortions but block telemedicine abortion, such as Arizona, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, Nevada, North Carolina, Ohio, Pennsylvania, South Carolina, Utah and Wisconsin.
In January, a physician named Amy Bryant filed a lawsuit challenging a North Carolina law requiring doctors to dispense mifepristone in-person in a specially certified surgical facility after state-mandated counseling and a mandatory 72-hour delay. Judge Chambers ruling in GenBioPro v. Sorsaia could help Bryant and others challenge abortion pill restrictions that go beyond FDA rules.
“Congress has been clear that it is the FDA that regulates medications in this country,” said Perryman. “With respect to mifepristone in particular, Congress has specifically deemed mifepristone to be regulated in a certain way. It’s unlawful for West Virginia to maintain a restriction that conflicts with and is an obstacle to the intent of Congress, and that has broad implications for our country, for the accessibility of medications, and for the availability of this essential medication.”
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