Abortion tablet maker GenBioPro solicits orders for mifepristone

A box containing a mifepristone tablet is seen at the Blue Mountain Clinic in Missoula, Montana, the United States, February 28, 2023. REUTERS/Callaghan O’Hare

Callaghan O’hare | Reuters

A pharmaceutical company that distributes the majority of U.S. supplies of the abortion pill mifepristone sued the Food and Drug Administration on Wednesday to keep its generic version of the drug on the market as a messy legal battle over the drug is fought in multiple federal courts.

GenBioPro petitioned the United States District Court for Maryland to prevent the FDA from rescinding the company’s 2019 authorization to sell the company’s version of mifepristone.

The lawsuit states that the FDA cannot withdraw its approval without determining an “imminent public health threat” and providing an opportunity for a hearing.

GenBioPro has said in court filings that it supplies two-thirds of the mifepristone used for abortions in the US.

“In the United States, federal law protects the right to market the drug once a drug has passed the rigorous FDA review process and received approval,” 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 US 5th Circuit Court of Appeal ruling last week, upholding part of a sweeping order by Texas US District Judge Matthew Kacsmaryk blocking the FDA’s generic approval of GenBioPro.

The same Court of Appeals ruling also imposed severe restrictions on the use and distribution of the brand-name version of the drug Mifeprex, sold by Danco Laboratories.

The Supreme Court last week temporarily stayed the Court of Appeals’ rulings. For the time being, this block has allowed the drug to remain widely available.

However, the Supreme Court could move as early as Wednesday to lift that ban or leave it in place pending further legal challenges to the verdicts

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

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

“No court in history has ever ‘suspended’ or ‘suspended’ a long-standing FDA approval, and the FDA has no authority to respond to or implement those decisions,” GenBioPro’s attorneys wrote.

Complicating the tangled legal landscape is an executive order by Judge Thomas Rice in the US East District of Washington that prevents the FDA from restricting access to mifepristone in 17 states and Washington DC

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