December 2, 2023

A box containing mifepristone tablets is seen at the Blue Mountain Clinic in Missoula, Montana, U.S., February 28, 2023. REUTERS/Callaghan O’Hare

Callahan O’Hare | Reuters

A pharmaceutical company that distributes much of the U.S. supply of the abortion drug mifepristone sued the U.S. Food and Drug Administration on Wednesday, trying to keep its generic version on the market, as a messy legal battle against the drug unfolds in federal courts in multiple countries.

GenBioPro Asked the U.S. District Court for the District of Maryland to pre-emptively prevent the FDA from revoking the company’s 2019 approval to distribute the company’s version of mifepristone.

The lawsuit says the FDA cannot revoke the approval without finding an “imminent danger to public health” and providing an opportunity for a hearing.

GenBioPro said in court documents that it supplies two-thirds of the mifepristone used for abortions in the United States.

“In the United States, once a drug has passed a rigorous FDA review process and is approved, federal law protects the right to market that drug,” GenBioPro CEO Evan Masingill said in a statement. “GenBioPro will use all regulatory and legal tools to protect patient and provider access to mifepristone.”

The lawsuit was filed in response to a ruling last week by the U.S. Court of Appeals for the Fifth Circuit upholding part of a sweeping order by U.S. District Judge Matthew Kacsmaryk in Texas that blocked the FDA from approving a generic version of GenBioPro.

The same appeals court ruling also imposed severe restrictions on how the brand-name drug Mifeprex, sold by Danco Laboratories, can be used and distributed.

The Supreme Court put the appeals court ruling on hold last week. The block now allows the drug to remain widely available.

But the Supreme Court could move as early as Wednesday to lift the ban or keep it pending further legal challenges to the ruling

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In a recent legal brief, GenBioPro asked the Supreme Court to block a lower court ruling that would have suspended FDA approval of its generic mifepristone.

“These circumstances are unprecedented,” GenBioPro’s attorneys wrote in the company’s lawsuit filed Wednesday in Maryland.

“No court in history has ‘set aside’ or ‘suspended’ an FDA approval for a long period of time, and there is no template for FDA to respond to or enforce these decisions,” GenBioPro’s attorneys wrote.

Further complicating the chaotic legal environment is an order this month by U.S. Judge Thomas Rice for the Eastern District of Washington banning the FDA from restricting the use of mifepristone in 17 states and Washington, D.C.