The FDA approved mifepristone more than 20 years ago.
A federal judge in Texas on Friday halted the Food and Drug Administration's approval of the abortion pill mifepristone, delivering a blow to abortion rights advocates in the wake of the Supreme Court's dismantling of the constitutional right to abortion., U.S. District Judge Matthew Kacsmaryk said the FDA's two-decade-old approval violated a federal rule that allows for accelerated approval for certain drugs and, along with subsequent actions by the agency, was unlawful.
"The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in and will be appealing the court's decision and seeking a stay pending appeal," Attorney General Merrick Garland also said in a statement Friday evening."Today's decision overturns the FDA's expert judgment, rendered over two decades ago, that mifepristone is safe and effective.
The FDA approved mifepristone more than 20 years ago, and the drug is taken together with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.
"Removing access to mifepristone would cause worse health outcomes for patients who rely on the availability of mifepristone to safely and effectively terminate their pregnancies," the FDA told the court, adding that the"sudden absence" of medication abortion would likely impose"real and significant harms" to patients choosing to take abortion pills out of medical necessity, for privacy or to avoid further trauma.
In his ruling, Kacsmaryk said the groups' challenges to the FDA's actions, beginning with its approval in 2000 and to 2021, have a substantial likelihood of success on the merits, and found the agency exceeded its authority in approving mifepristone.
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