For now, the drug the Food and Drug Administration approved in 2000 appeared to remain at least immediately available in wake of two separate rulings that were issued in quick succession by federal judges in Texas and Washington.
“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School. “The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
“The Court does not second-guess FDA’s decision-making lightly.” Kacsmaryk wrote. “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.” Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.
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