The Department will continue to defend the FDA’s decision,” Garland said.ĭefendant Danco Laboratories, which manufactures mifepristone, also filed a notice of appeal to the 5th Circuit on Friday. “Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. ![]() Attorney General Merrick Garland also said in a statement that the DOJ plans to appeal Kacsmaryk’s decision. On Friday night, the Department of Justice filed a notice of appeal to the 5th Circuit Court of Appeals, indicating that the government plans to appeal. “It is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.” “This does not just affect women in Texas - if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state,” Biden said in a statement. Some abortion providers said they intend to do that if access to mifepristone is cut off, even though the one-drug approach has been shown in clinical trials to be somewhat less effective than the two-pill regimen.īiden said the Texas ruling poses a risk to abortion rights everywhere in the nation. Misoprostol, which is not affected by the injunction, is not FDA-approved to terminate pregnancies on its own - doctors would have to prescribe it off-label for that purpose. That would leave a surgical procedure or off-label use of misoprostol on its own as the only options in states where abortion is legal. If the stay on the FDA's mifepristone approval goes into effect, the drug would no longer be available anywhere in the U.S. ![]() ![]() "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." "The Court does not second-guess FDA’s decision-making lightly," Kacsmaryk wrote.
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