Just hours after a federal judge in Texas blocked the Food and Drug Administration’s approval of the abortion pill mifepristone on Friday, the Biden administration filed its notice of appeal.
In his 67-page filing, the Trump-appointed U.S. District Judge Matthew Kacsmaryk gave the government one week to appeal and to request emergency relief.
President Joe Biden said in a statement on Friday night: the “Court in this case has substituted its judgment for FDA, the expert agency that approves drugs. 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 president continued, “The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk.”
Vice President Kamala Harris also reacted in a statement on Friday: “Simply put: this decision undermines the FDA’s ability to approve safe and effective medications-from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin-based on science, not politics.” She added, “Each person in our nation should have the right to access safe and effective medication which has been approved by the FDA.”
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Mifepristone is one of two drugs used in a medication abortion, and the other drug—misoprostol—is legal. The FDA approved the use of mifepristone in 2000. However, Judge Kacsmaryk in his ruling wrote, “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.”
“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,’” he wrote.
Whether or not political pressure was the impetus, he said, “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions.”
Similar to the president and vice president, a number of government officials and reproductive rights advocates have also condemned the ruling.
“Mifepristone was approved by the FDA 20 years ago after a rigorous scientific and legal process, but access to this medication that millions rely on was stripped away with a stroke of a pen by a single person who was handpicked by Republican extremists set on a national ban,” Illinois Senator Tammy Duckworth said in the wake of the ruling. “If one judge in Texas can make a political decision that takes this off the shelves, what’s to stop another judge somewhere else from doing the same thing to insulin or any other prescription drug?”
