FDA Prevails in Blue State Suit Over Abortion Pill Safety (2)

The US Food and Drug Administration held off a legal challenge from a coalition of blue states over the abortion pill, mifepristone, after a federal district court concluded the agency came to a “reasonable conclusion” regarding its safety.

“Even under a deferential review, it appears FDA fully considered the important aspect of the issues in this case and came to a reasonable conclusion,” said Judge Thomas O. Rice Tuesday in an order for the US District Court for the Eastern District of Washington, granting the FDA summary judgment and vacating a preliminary injunction.

“The FDA did not ignore the laws that apply nor the regulations,” Rice added.

The order is a win for the agency after mostly Democratic-led states led by Washington state sued the FDA to eliminate prescriber certification requirements and a patient agreement form on the drug.

The states argued the FDA’s decision-making on mifepristone creates stigma, fear, and reluctance to prescribe a safe and essential medication and artificially limits the number of providers who can prescribe mifepristone.

“We are disappointed and respectfully disagree with the court’s decision,” Nick Brown, attorney general for Washington state, said in a statement.

“But I want to be clear that the court’s decision has no immediate impact on access to mifepristone here in Washington, where medication abortion remains safe, legal, and available. Medication abortions account for more than 65% of all abortions in Washington, and my office stands ready to fight any unlawful attempts to curtail mifepristone’s availability here.”

The decision comes amid a political battle over the medication, as Democratic states seek fewer restrictions and Republican-led states push for the FDA to review the safety of mifepristone. US Health and Human Services Secretary Robert F. Kennedy Jr. told Senate lawmakers in May he had ordered FDA Commissioner Marty Makary to do a “complete review” of the drug along with its labeling requirements.

In its summary judgment motion last December, the FDA under then-President Joe Biden said its decisions were needed to mitigate risks involving missed ectopic pregnancies and heavy bleeding.

The FDA argued that the blue states lack standing, have not exhausted their administrative claims, and cannot assert constitutional claims.

The judge, however, ordered those claims moot given the court’s disposition of the case.

“The Court cannot find, based on the full record before it, that the FDA was arbitrary and capricious in its decision,” Rice wrote.

The FDA did not immediately respond to a request for comment.

The case is Washington v. FDA, E.D. Wash., No. 1:23-cv-03026, order 7/8/25.