Texas Judge Pauses States' Lawsuit Against Abortion Pill

A federal judge in Texas has temporarily halted a lawsuit brought by the states of Texas and Florida that sought to sharply restrict nationwide access to the abortion medication mifepristone. The pause will remain in effect until December 1 or until the U.S. Food and Drug Administration (FDA) completes its ongoing safety review of the drug, whichever comes first.

U.S. District Judge Reed O'Connor in Fort Worth issued the order on Monday, noting that the Republican attorneys general of the two states and the FDA had jointly agreed to the stay. The judge, appointed by former President George W. Bush, also declined a motion from drugmakers GenBioPro and Danco Laboratories to dismiss the case entirely. The companies, which manufacture mifepristone, have intervened in the litigation.

The lawsuit, filed last December, challenges the FDA's original 2000 approval of mifepristone as well as subsequent regulatory changes made under the Obama and Biden administrations that expanded access to the drug. These include a 2023 rule permitting the medication to be dispensed through the mail. A separate lawsuit by Louisiana challenging that same regulation was put on hold by a judge in April.

The FDA first announced its review of mifepristone last year. The drug is used in more than 60 percent of abortions in the United States. Reports indicate the review has been delayed until after the November midterm elections.

Since the U.S. Supreme Court overturned the constitutional right to abortion in 2022, nearly half of U.S. states have banned or severely restricted the procedure. This has led to a surge in medication abortion and a series of legal battles over access to the drugs.

Medication abortion typically involves a two-drug regimen: mifepristone followed by misoprostol, used to terminate a pregnancy within the first ten weeks. Five states have filed three separate lawsuits, generally arguing that the FDA has not adequately evaluated the drug's safety and has disregarded risks to women.

Major medical groups and the FDA have repeatedly stated over the past quarter-century that mifepristone is safe and effective when used as directed, with serious adverse events being rare.