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Tipsheet

Biden Administration Responds to Federal Judge Blocking FDA Approval of Abortion Pill

AP Photo/Susan Walsh

A legal showdown over the abortion pill mifepristone will likely land at the Supreme Court after two competing rulings came down on Friday from judges in Texas and Washington state. 

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In Texas, U.S. District Judge Matthew J. Kacsmaryk suspended the Food and Drug Administration’s approval of mifepristone.

"The Court does not second-guess FDA's decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions," he wrote. "There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access; to chemical abortion — which was the 'whole idea of mifepristone.'"

The ruling will not go into effect for seven days, giving the government time to appeal. 

Kacsmaryk sided with the antiabortion group that brought the lawsuit and said the agency’s approval process was improperly rushed, and resulted in an unsafe drug regimen getting on the market.

Kacsmaryk said that FDA violated federal standards when it first approved mifepristone 23 years ago. [...]

He also hinted the agency bowed to political pressure, and deliberately “stonewalled” any challenges to the drug’s approval.

“Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now,” he wrote. (The Hill)

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Shortly after, U.S. District Judge Thomas Rice, who sits in the Eastern District of Washington, issued a decision in a separate case ordering the FDA to keep the “status quo.”

In a statement, Attorney General Merrick Garland said the federal government “strongly disagrees” with the Texas ruling and will appeal.

“The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court’s decision and seeking a stay pending appeal. Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision,” he said. 

“Separately, the Justice Department is reviewing the decision of the District Court for the Eastern District of Washington in Washington et al. v. FDA,” Garland added. The Department is committed to protecting Americans’ access to legal reproductive care.” 

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