Manufacturer of generic version of abortion pill mifepristone sues FDA to keep drug on the market
Washington — The pharmaceutical company that makes the generic version of the widely used abortion pill mifepristone filed a lawsuit against the Food and Drug Administration on Wednesday in an effort to keep the drug on the market.
The dispute brought by GenBioPro in federal district court in Maryland comes amid looming uncertainty about the availability of mifepristone after a federal district court in Texas suspended the FDA's approval of the drug earlier this month, and an appeals court rolled back actions taken by the agency beginning in 2016.
Among the moves blocked by the U.S. Court of Appeals for the 5th Circuit was the FDA's 2019 approval of a GenBioPro's application to market a generic version of mifepristone. The Supreme Court issued a temporary order last week preserving access to the drug until 11:59 p.m. Wednesday, and the hold was extended to 11:59 p.m. Friday.
GenBioPro's lawsuit against the FDA is the latest in a legal barrage involving medication abortion that has thrown the availability of mifepristone into uncertainty. The drug maker warns in its court filing that if the order from the 5th Circuit takes effect, "the result will be chaos."
"These circumstances are unprecedented," lawyers for the drug maker wrote in its suit. "No court in history has ever 'stayed' or 'suspended' a longstanding FDA approval, and FDA has no template for resounding to — or implementing — those decisions."
GenBioPro, the country's only manufacturer of generic mifepristone, is asking the court to block the FDA from depriving it "of its constitutional and statutory rights to market mifepristone without affording GenBioPro due process of law." The agency said it does not comment on possible, pending or ongoing litigation.
The FDA first approved Mifeprex, the branded version of mifepristone, in 2000, and the agency has over the last 23 years relaxed the rules surrounding its usage, including extending the time when patients can take the drug from 7 weeks gestation to 10 weeks, broadening the health care providers who can prescribe it and allowing it to be dispensed by mail.
But in an April 7 order, U.S. District Judge Matthew Kacsmaryk halted the FDA's approval and blocked actions taken by the agency beginning in 2016. The Biden administration appealed the decision to the 5th Circuit, which put on hold the significant part of Kacsmaryk's decision regarding mifepristone approval.
Still, the appeals court unwinded the FDA's policy changes since 2016, limiting access to mifepristone.
The Biden administration then turned to the Supreme Court for emergency relief, and Justice Samuel Alito on Friday granted an administrative stay, which ensured mifepristone would remain available while the court considered the issue. Alito's order is now to expire Friday at midnight, after which the 5th Circuit's decision limiting mifepristone would take effect absent action from the high court.
The Supreme Court could grant the Biden administration's request to maintain broad access to mifepristone, or fail to act by its self-imposed deadline.
Separate from the Texas case, and less than an hour after Kacsmaryk issued his decision, a federal judge in Washington state issued an order blocking the FDA from altering the status quo as it relates to mifepristone's availability in 17 states and the District of Columbia.
Amid the fast-evolving legal landscape surrounding the drug, GenBioPro said it reached out to the FDA for assurances that it will "follow its own procedures and adhere to the mandates" of federal law and the Constitution in its regulation of mifepristone.
"Notwithstanding the exigent circumstances and the numerous tools available to FDA, FDA has repeatedly refused to assure GenBioPro or the public that it will afford GenBioPro adequate procedures before suspending GenBioPro's ANDA approval," the lawsuit claims.