Key facts
- A federal judge has paused a lawsuit filed by Florida and Texas that sought to severely limit access to the abortion pill mifepristone nationwide.
- U.S. District Judge Reed O'Connor cited the agreement between the states and the FDA to pause the case during the drug's safety review.
- The judge rejected a motion by mifepristone manufacturers GenBioPro and Danco Laboratories to dismiss the lawsuit.
- The lawsuit challenges the FDA's initial 2000 approval of mifepristone and subsequent regulations that expanded its access.
- The FDA is currently reviewing the safety of mifepristone, which is used in over 60% of U.S. abortions.
A federal judge has temporarily halted a lawsuit brought by Florida and Texas that aimed to significantly restrict nationwide access to the abortion pill mifepristone. U.S. District Judge Reed O'Connor in Fort Worth, Texas, stated on Monday that the pause was reasonable given that the states' Republican attorneys general and the U.S. Food and Drug Administration (FDA) had agreed to put the case on hold while the agency completes its review of the drug's safety.
Judge O'Connor, an appointee of former President George W. Bush, also denied a motion by mifepristone manufacturers GenBioPro and Danco Laboratories to dismiss the case. The lawsuit, filed in December, challenges the FDA's original 2000 approval of mifepristone and subsequent regulations enacted under Democratic Presidents Barack Obama and Joe Biden that expanded access, including a 2023 rule allowing the pill to be dispensed via mail.
The FDA announced its review of mifepristone, a drug used in over 60% of U.S. abortions, last year. Reports suggest this review has been delayed until after the November midterm elections. This legal challenge is one of several filed by five states, which generally argue that the FDA has not adequately assessed mifepristone's safety and effectiveness since its initial approval, disregarding potential risks to users.
Major medical organizations and the FDA have consistently stated that mifepristone is safe and effective when used as directed, with serious adverse events being rare. The legal battles over medication abortion access have intensified since the U.S. Supreme Court overturned the constitutional right to abortion in 2022, leading nearly half of U.S. states to ban or severely restrict the procedure.