Abortion pill maker sues over ban in West Virginia

Abortion pill maker GenBioPro filed a lawsuit Wednesday arguing West Virginia’s sweeping ban on the procedure is unconstitutional, one of a series of lawsuits testing the legality of medical abortion in the post-Roe legal landscape.

GenBioPro manufactures mifepristone, the first pill in a two-drug regimen to be used to perform medical abortions. Medical abortion has become a hot topic since the Supreme Court’s June decision to overturn Roe v. Wade, which guaranteed the constitutional right to abortion.

Medical abortion now accounts for more than half of all abortions performed in the United States, according to the Guttmacher Institute, a research group that supports abortion rights. The Biden administration has tried to bolster access to abortion pills, even as more than a dozen states have banned the procedure.

The drugmaker, which filed its case in federal court in West Virginia, argues that the FDA’s regulations on abortion drugs override state law. Also Wednesday, a North Carolina doctor sued officials over the state’s strict requirements for the use of mifepristone. In November, anti-abortion medical providers put up the “anti-abortion mirror” of the two lawsuits, legal expert Rachel Rebouché said; That lawsuit argues that the FDA acted outside of its authority by approving medical abortion in 2000. The results of the cases could determine who can access medical abortion amid the patchwork of abortion laws that have sprung up across the country since the decision of the higher court.

“Think of a federal court in Texas saying mifepristone shouldn’t be on the market, a federal court in North Carolina saying the FDA is running ahead of state law,” said Rebouché, dean of the law school at Temple University, in an interview with NBC News. “There has to be confusion.”

The FDA approved mifepristone for medical abortion up to 10 weeks of pregnancy more than two decades ago. The agency expanded access to the drug in 2021 by allowing providers to prescribe abortion pills via telemedicine and mail them to patients, and has recently taken additional steps to expand availability.

In September, the governor of West Virginia signed legislation banning abortion in almost all cases. The state also restricts the use of telemedicine to prescribe mifepristone.

GenBioPro said the West Virginia restrictions have caused it significant losses in sales, customers and revenue. The lawsuit argues that state legislation should give way to the federal regulatory authority granted to the FDA by Congress. The North Carolina lawsuit is based on a similar argument.

“Abortion law and the state of abortion legality flicker,” Rebouché said. “One day it’s a constitutional right, the next day there’s a Supreme Court decision, in the weeks since a dozen states rushed to criminalize, those laws are still being interpreted, and on top of that, these conflicts between the states and the federal government. We are seeing a really dynamic and rapidly changing legal landscape.”

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