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On Wednesday, a pharmaceutical company that distributes the majority of the abortion pill mifepristone in the United States sued the Food and Drug Administration in an attempt to keep its generic version of the drug on the market, amid a tumultuous legal battle over the medication in multiple federal courts.
GenBioPro, a maker of abortion pills, has asked a federal court in the United States to keep generic mifepristone on the market.
GenBioPro has asked the United States District Court for the District of Maryland to prevent the FDA from withdrawing the company’s 2019 approval to distribute its version of mifepristone.
According to the lawsuit, the FDA cannot withdraw its license unless it finds a “imminent harm to public health” and provides an opportunity for a hearing.
According to court documents, GenBioPro distributes two-thirds of the mifepristone used in abortions in the United States.
“In the United States, once a medicine has been reviewed and approved by the FDA, federal law preserves the ability to market the drug,” GenBioPro CEO Evan Masingill said in a statement. “GenBioPro will employ all regulatory and legal instruments available to defend patients’ and providers’ access to mifepristone.”
The case was filed in response to a verdict last week by the United States 5th Circuit Court of Appeal, which upheld part of a broad order by Texas U.S. District Judge Matthew Kacsmaryk that prevents the FDA from approving GenBioPro’s generic version.
The same appeals court order put stringent limits on how Danco Laboratories’ brand name version of the medicine Mifeprex is used and supplied.
