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HOUSTON - A Texas federal judge has halted the FDA's approval of mifepristone, a medication used for medically-induced abortions.
Appointed by the Trump administration, Judge Matthew Kacsmaryk of Amarillo agrees with the anti-abortion groups in the lawsuit that claims the drug was improperly approved for use by the FDA over 20 years ago, which imposes dangers on the women who use it.
"The Court does not second-guess FDA’s decision-making lightly," he states in his ruling. "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."
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Mifepristone, also known as Mifeprex, is part of a two-pill regimen responsible for over half of the abortions in the U.S. Misoprostol is given one to two days after mifepristone is administered.
Dr. Marcel Thompson, a Board-certified gynecologist, and obstetrician at the Restorative Health & Wellness Centre said the drug makes the procedure safer for the patient.
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"It's made it safer," said Thompson. "The woman doesn't have to go through a surgical procedure. She can take it at home…this particular judge has gone against FDA approval of a drug that's been cleared by American College OB-GYNs. It's cleared as a safe, effective treatment."
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Within minutes of the Texas ruling, Washington state Judge Thomas O. Rice - appointed by President Obama - issued an injunction that prevents regulators from restricting access to the same drug.
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The dueling national injections do not immediately prevent women in the United States from wanting to use the drug. Pharmacies and abortion clinics can continue to provide it.
President Biden announced on Twitter that he plans to fight against it. He wrote the Justice Department will file an appeal and seek an immediate stay of the decision.
"We look forward to the Biden Administration’s swift appeal of this twisted ruling," says Texas Democratic Party Chairman Gilberto Hinojosa in a statement. "Texas Democrats will continue to fight tooth-and-nail to ensure every woman in Texas is able to make her own choices about her own body – and that every family in Texas is able to grow if, when, and how it chooses."