A generic-mifepristone maker sued the U.S. Food and Drug Administration to protect access to the medical abortion pill amid a welter of litigation stretching from Texas to Washington.
The lawsuit by GenBioPro Inc., filed Wednesday in federal court in Maryland, comes as the U.S. Supreme Court delayed until Friday a decision on which restrictions on the pill will remain in place after a federal judge in Texas blocked the FDA’s approval of mifepristone in a separate lawsuit.
GenBioPro makes most of the mifepristone sold in the U.S. It says in its suit that if the FDA is forced to comply with the Texas court order, the drug maker would face “imminent, catastrophic, and irreparable harm.”
The FDA said it doesn’t comment on possible, pending or ongoing litigation.
The Texas-based case was brought by a group of doctors who contended that mifepristone is unsafe and never should have been granted approval.
After U.S. District Judge Matthew Kacsmaryk in Amarillo issued an order this month temporarily blocking FDA approval of mifepristone, a federal appeals court said the drug could remain available, with restrictions, while the lawsuit proceeds.
The appellate court reversed several regulatory changes approved by the FDA since 2016, including a decision to permit the drug to be distributed through the mail and prescribed via telehealth. Its ruling also appears to block the 2019 approval of GenBioPro’s generic version of mifepristone.
The Supreme Court has paused implementation of the appeals court’s order and is set to decide by the end of the day on Friday whether the order will stay in place while the full case is litigated.
The drug maker warned in its lawsuit that, should the order from the appeals court go into effect, “the result will be chaos.”
“These circumstances are unprecedented,” according to the complaint. “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.”
The FDA first approved mifepristone for use in 2000, with strict safety regulations. Only certain doctors could prescribe the pill, and it had to be administered at the provider’s office. But the agency faced pressure for years from medical bodies and advocacy groups to loosen restrictions on the abortion pill, given the wealth of data supporting the drug’s safety and efficacy.
After a law was passed in 2007 that expanded the FDA’s risk management authority, the agency created a program known as Risk Evaluation and Mitigation Strategy, or REMS. This was designed to ensure certain drugs — like antipsychotics and opioids — that carried greater risks were dispensed under stricter conditions. A few years later, the agency imposed a REMS on mifepristone, codifying the restrictions on the drug.
After reviewing around 15 years of safety data and doing its own four-year assessment of the restrictions on the abortion pill, the FDA revised its rules in 2016 to allow the drug to be used through 10 weeks of pregnancy instead of seven. Such changes would be blocked under the order from the federal appeals court.
The case is GenBioPro Inc. v. US Food and Drug Administration, 23-cv-01057, US District Court, District of Maryland.
