Abortion pill manufacturer GenBioPro has asked a court to halt West Virginia’s restrictions on the drug mifepristone, opening another legal avenue for blunting states’ post-Roe powers.
Filed Wednesday, the company’s lawsuit argues that West Virginia violated the U.S. Constitution by stepping on the Food and Drug Administration’s (FDA) authority and harming interstate commerce.
The state had laid out several restrictions on using the pill (e.g. via telemedicine) before passing in September the Unborn Child Protection Act, which bans most abortions. Derisively referring to the law as the “Criminal Abortion Ban,” GenBioPro argued that it severely constricted the market for mifepristone statewide. The company’s suit also noted that it “sells only generic mifepristone and misoprostol. Both drugs are used in medication abortions, and their sales are the company’s sole source of revenue.”
West Virginia Attorney General Patrick Morrissey defended the law with a brief statement in which he cited the Supreme Court’s decision in Dobbs.
“We are prepared to defend West Virginia’s new abortion law to the fullest,” Morrisey said in a press release Wednesday. “While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue. I will stand strong for the life of the unborn and will not relent in our defense of this clearly constitutional law.”
GenBioPro is attempting to argue that “[s]tates are not free to second-guess or override” the FDA’s regulatory authority. Its lawsuit adds that “[t]he Supreme Court’s decision in Dobbs did not displace Congress’s and FDA’s roles in protecting the public health by deciding whether drugs are safe and effective, determining which precautions — if any — are necessary to ensure a drug’s safe use, and ensuring safe and effective drugs are available to the public. Dobbs addressed only the underlying personal constitutional privacy right as it pertains to abortion; it did not speak to federal law regulating a drug maker’s sale and distribution of, or a patient’s access to, medication that is FDA-approved for distribution nationwide.”
Wednesday’s lawsuit has added to mounting litigation surrounding the abortion pill, as well as questions about how effective states will be in preventing abortions within their borders. GenBioPro had filed a similar lawsuit in Mississippi, where Dobbs originated, but reportedly dropped the case in August while citing a change in legal strategy. Another lawsuit in North Carolina involves an OB/GYN alleging that the state’s mifepristone restrictions interfere with federal regulation.
Both sides of the debate reportedly see a potential lawsuit in Wisconsin as well. And in Texas, a separate lawsuit is challenging the FDA’s decision to approve the drug.
Extremely controversial, the abortion pill has encountered liberalized and restrictive regulations under different presidents. President Biden’s FDA notably reversed its predecessor’s decision to maintain the in-person dispensing requirement for the drug regimen – something pro-life advocates maintain is critical to prevent potentially fatal health complications.
Under Biden, however, the FDA removed those requirements, arguing that the literature indicated women could safely obtain the pill without that requirement. More recently, it released updated guidance allowing certified pharmacies to dispense the abortion pill. That prompted South Dakota Gov. Kristi Noem to remind pharmacies they faced penalties for dispensing the life-ending drug, which women may obtain by mail.
