A box containing a Mifepristone tablet is seen at Blue Mountain Clinic in Missoula, Montana, U.S. February 28, 2023. REUTERS/Callaghan O’Hare
Callaghan O’hare | Reuters
A pharmaceutical company that distributes the majority of the U.S. supply of the abortion pill mifepristone sued the Food and Drug Administration on Wednesday in an effort to keep its generic version of the drug on the market as a chaotic legal battle over the medication plays out in multiple federal courts.
GenBioPro asked the U.S. District Court for Maryland to preemptively block the FDA from pulling the company’s 2019 approval to distribute the company’s version of mifepristone.
The suit says the FDA cannot pull its approval without finding an “imminent hazard to public health” and providing an opportunity for a hearing.
GenBioPro has said in court filings that it supplies two-thirds of the mifepristone used in the U.S. for abortions.
“In the United States, once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug,” GenBioPro CEO Evan Masingill said in a statement. “GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”
The lawsuit was lodged in response to a ruling last week by the U.S. 5th Circuit Court of Appeal, which upheld part of a sweeping order by Texas U.S. District Judge Matthew Kacsmaryk that blocks GenBioPro’s generic approval by the FDA.
The same appeals court ruling also imposed severe restrictions on how the brand name version of the drug Mifeprex, which is sold by Danco Laboratories, is used and distributed.
The Supreme Court last week temporarily put the appeal’s court rulings on hold. That block has for now allowed the medication to remain broadly available.
But the Supreme Court as early as Wednesday could move to lift that ban or leave it in place pending further legal challenges to the rulings
GenBioPro in a recent legal brief asked the Supreme Court to block the lower court rulings that would suspend the FDA’s approval of its generic version of mifepristone.
In the company’s lawsuit filed Wednesday in Maryland, GenBioPro’s lawyers wrote, “These circumstances are unprecedented.”
“No court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval, and FDA has no template for responding to—or implementing—those decisions,” GenBioPro’s attorneys wrote.
Further complicating the muddled legal landscape is a order this month by Judge Thomas Rice in U.S. Eastern District of Washington, which bars the FDA from restricting access to mifepristone in 17 states and Washington D.C.
