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https://thehill.com/policy/healthcare/3873279-federal-judge-shuts-down-abortion-pill-approval/
In an unprecedented decision, a federal judge in Texas has issued a stay that will shut down the prescribing and distribution of mifepristone in seven days, one of two drugs used for medication abortions that has been on the market in the U.S. for more than two decades.
District Court Judge Matthew Kacsmaryk, an appointee of former President Trump, gave the government a weeklong window to appeal and seek emergency relief before his ruling goes into effect.
The FDA appealed the decision to the conservative 5th Circuit Court of Appeals later on Friday.
Separately on Friday, U.S. District Judge Thomas Rice, an appointee of former President Obama who sits in the Eastern District of Washington, blocked the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in 17 states and Washington, D.C. that filed a lawsuit saying the drug was too tightly regulated.
The dueling rulings could have far-reaching implications for access to abortion nationwide, as well as the authority of the entire Food and Drug Administration. The dispute could eventually reach the Supreme Court.
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.
“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 also hinted the agency bowed to political pressure, and deliberately “stonewalled” any challenges to the drug’s approval.
In an unprecedented decision, a federal judge in Texas has issued a stay that will shut down the prescribing and distribution of mifepristone in seven days, one of two drugs used for medication abortions that has been on the market in the U.S. for more than two decades.
District Court Judge Matthew Kacsmaryk, an appointee of former President Trump, gave the government a weeklong window to appeal and seek emergency relief before his ruling goes into effect.
The FDA appealed the decision to the conservative 5th Circuit Court of Appeals later on Friday.
Separately on Friday, U.S. District Judge Thomas Rice, an appointee of former President Obama who sits in the Eastern District of Washington, blocked the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in 17 states and Washington, D.C. that filed a lawsuit saying the drug was too tightly regulated.
The dueling rulings could have far-reaching implications for access to abortion nationwide, as well as the authority of the entire Food and Drug Administration. The dispute could eventually reach the Supreme Court.
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.
“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 also hinted the agency bowed to political pressure, and deliberately “stonewalled” any challenges to the drug’s approval.
