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 vast majority of the U.S. supply of the abortion pill mifepristone sued the Food and Drug Administration on Wednesday in an effort to maintain its generic version of the drug in the marketplace 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 corporate’s 2019 approval to distribute the corporate’s version of mifepristone.
The suit says the FDA cannot pull its approval without finding an “imminent hazard to public health” and providing a possibility for a hearing.
GenBioPro has said in court filings that it supplies two-thirds of the mifepristone utilized in the U.S. for abortions.
“In america, once a drug has been through the rigorous FDA review process and received approval, federal law protects the suitable to market the drug,” GenBioPro CEO Evan Masingill said in an announcement. “GenBioPro will use all regulatory and legal tools to guard access to mifepristone for patients and providers.”
The lawsuit was lodged in response to a ruling last week by the U.S. fifth Circuit Court of Appeal, which upheld a part of a sweeping order by Texas U.S. District Judge Matthew Kacsmaryk that blocks GenBioPro’s generic approval by the FDA.
The identical 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 stay broadly available.
However 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 temporary asked the Supreme Court to dam the lower court rulings that will suspend the FDA’s approval of its generic version of mifepristone.
In the corporate’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.
