Health Law Update

Home | Health Law Update

On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their arguments that the FDA approval of the drug in 2000 was arbitrary and capricious. Accordingly, the court stayed the FDA’s 2000 approval of mifepristone and all subsequent challenged actions related to that approval.

core/paragraph

The Department of Justice requested that the United States Court of Appeals for the Fifth Circuit stay the Northern District of Texas’ order. On April 12, the Fifth Circuit granted the request in part, preserving some levels of access to mifepristone but with more restrictions than were in place prior to the Northern District of Texas’ decision. The Department of Justice quickly announced that it would seek emergency relief from the Supreme Court.

On April 21, the Supreme Court ordered that the April 7 order of the Northern District of Texas be stayed pending the appeal in the Fifth Circuit and a potential petition for the Fifth Circuit’s decision on such appeal to be reviewed by the Supreme Court. The Fifth Circuit is set to hear the case beginning on May 17.

The order ensures that mifepristone will remain widely available through at least May 17. If the Fifth Circuit upholds the Northern District of Texas’ decision, the FDA’s approval of the drug will be stayed and access to the drug will be severely limited. The Supreme Court may then agree to review the Fifth Circuit’s decision, which would halt the Northern District of Texas’ order until the Supreme Court issues its final decision.

Supreme Court Orders That Mifepristone Remain Widely Available Pending Appeal in Fifth Circuit