The future of mifepristone, a medication used in more than half of U.S. abortions, was thrown into legal uncertainty Friday after federal judges in Texas and Washington issued conflicting orders over the Food and Drug Administration’s authority and the drug’s continued availability.

U.S. District Judge Matthew Kacsmaryk in Texas stayed the FDA’s 2000 approval of mifepristone but delayed his order for seven days to allow an appeal. Hours later, U.S. District Judge Thomas Rice in Washington directed the FDA to preserve the status quo for mifepristone in 17 states and the District of Columbia. The competing rulings create immediate questions about how one federal agency can comply with both commands if the Texas order takes effect.

The Texas ruling reaches back more than two decades

The Texas case, Alliance for Hippocratic Medicine v. FDA, was brought by anti-abortion medical organizations and physicians challenging the agency’s original approval and later regulatory changes. Kacsmaryk concluded that the plaintiffs were likely to succeed on key claims and ordered the approval stayed while litigation proceeds. The Washington Post reported that the decision represents an extraordinary judicial intervention into a drug approval that has remained in place for more than 20 years.

Mifepristone is used with misoprostol in the standard two-drug medication-abortion regimen. FDA has approved the drug for termination of pregnancy through 10 weeks and has modified its risk-management rules over time as additional evidence accumulated. The agency’s mifepristone information describes the approved regimen, safety monitoring and conditions governing distribution.

The Texas plaintiffs argue that FDA exceeded its authority and understated safety concerns. The federal government and Danco Laboratories, which markets the branded drug Mifeprex, dispute those claims and maintain that the approval rests on extensive evidence and long regulatory experience.

A Washington court issued the opposite command

The Washington case was brought by Democratic attorneys general challenging federal restrictions on mifepristone rather than seeking withdrawal. Rice’s Friday order did not remove those restrictions, but it barred FDA from altering the drug’s existing availability in the plaintiff jurisdictions while that litigation proceeds.

Washington Attorney General Bob Ferguson said in a statement that the order preserves access in the participating states and District of Columbia. New York Attorney General Letitia James likewise described the Washington ruling in an April 7 response while condemning the Texas decision.

The divergence is more than a symbolic disagreement. If the Texas stay becomes effective nationwide while the Washington injunction requires unchanged access in the named jurisdictions, FDA could face legally incompatible duties. That conflict increases the likelihood of rapid appellate review and potentially Supreme Court involvement.

The Justice Department is appealing

Attorney General Merrick Garland said Friday that the Justice Department “strongly disagrees” with the Texas decision and will appeal while seeking a stay pending review. His official statement emphasized that the ruling displaces FDA’s expert judgment that mifepristone is safe and effective. The department is separately reviewing the Washington order.

President Joe Biden also criticized the Texas ruling. In an April 7 statement, he argued that allowing a single district court to displace FDA’s scientific judgment could expose other longstanding drug approvals to ideological litigation. The administration’s position is that decisions about whether a medicine is safe and effective should remain rooted in the statutory process Congress assigned to FDA.

The plaintiffs and their supporters argue the opposite: that courts must review whether FDA complied with governing law and adequately considered safety evidence. Kacsmaryk’s opinion sharply criticized the agency’s handling of mifepristone and its later changes to prescribing and dispensing restrictions.

The immediate status remains unchanged for seven days

Patients and clinicians are not facing an instant nationwide withdrawal because the Texas judge delayed his order for one week. The Guardian reported that providers were continuing existing practices while the government seeks emergency appellate relief. Some clinics have prepared to use misoprostol alone if mifepristone becomes unavailable, although the two-drug regimen is the U.S. standard and is generally more effective.

The dispute also extends beyond abortion policy. FDA’s drug-approval system depends on sponsors and clinicians being able to rely on agency decisions unless new scientific evidence, safety signals or lawful regulatory proceedings justify changes. Pharmaceutical and medical groups are therefore watching whether courts can suspend approval based on litigation initiated decades after an agency decision.

At the same time, the case cannot be separated from the transformed legal environment after the Supreme Court ended the federal constitutional right to abortion last year. State laws now vary sharply, and medication abortion has become a central mechanism for access in states where abortion remains legal.

Friday’s two orders ensure that the next stage will focus on appellate courts as much as clinics. The core questions are now intertwined: whether the Texas plaintiffs have standing, whether their claims are timely, how much deference FDA receives for scientific judgments and how federal courts reconcile contradictory injunctions affecting the same national drug approval. Until higher courts act, mifepristone remains available under current federal rules, but its legal status is more uncertain than at any point since the FDA approved it in 2000.