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Texas federal judge halts FDA approval of abortion pill mifepristone

U.S. District Judge Matthew Kacsmaryk, a Trump appointee, concluded the agency should have denied approval of mifepristone in 2000.

AMARILLO, Texas (CN) — A federal judge in Texas dealt a blow to abortion rights Friday evening as he halted the Food and Drug Administration’s decades-old approval of the abortion pill mifepristone, concluding the agency ignored safety concerns due to political pressure.

Taken with stomach ulcer drug misoprostol, mifepristone can induce abortion up to ten weeks into a pregnancy.

U.S. District Judge Matthew Kacsmaryk in Amarillo — a Donald Trump appointee — rejected the FDA’s nearly 23-year approval of the drug, concluding the agency “abandoned its safety proposals” and should have refused approval if there was “insufficient information” as to the drug’s safety.

The Biden administration has denied claims the FDA accelerated the review process of the drug, arguing it was only approved four years after it was first submitted.

“The court does not second-guess FDA’s decision-marking lightly,” the 67-page opinion states. “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 increasing ‘access’ to chemical abortion — which was the ‘whole idea of mifepristone.’”

Kacsmaryk declined to withdraw or suspend the FDA’s approval of mifepristone, instead issuing a preliminary injunction for a stay under the Administrative Procedure Act. He also delayed the application of his order for seven days to give the Biden administration time to appeal to the right-leaning Fifth Circuit.

The ruling comes ten months after the U.S. Supreme Court overturned Roe v. Wade, allowing states to ban abortion. The use of the abortion pill has grown in prominence since the ruling. Medication abortions make up 53% of all abortions in the United States, according to the Guttmacher Institute — a reproductive rights research and policy organization.

The lawsuit made headlines last month when The Washington Post reported the judge unusually delayed putting a hearing in the case on the public docket until mere days beforehand. The newspaper reported he did so to minimize threats and protests and that he asked attorneys not to publicly discuss the plans.

Federal trial courts typically schedule hearings weeks or months in advance and promptly add them to the public docket, in line with Americans’ expectation of an open and fair judicial system. The secrecy resulted in several media entities filing protests with the court over the delayed disclosure of the hearing. Kacsmaryk responded by allowing a closed-circuit, live broadcast of the hearing being provided at the federal courthouse in Dallas — 375 miles southeast of Amarillo.

The Christian and conservative Alliance for Hippocratic Medicine said during the hearing that they have standing to sue because their anti-abortion members face harm and that they are “severely impacted” from practicing medicine. The Biden administration retorted the plaintiffs were relying on “speculative injuries” as a flimsy basis to bring about the “wholesale withdrawal of a safe and effective drug.”

It is likely the matter will be ultimately decided by the Supreme Court, as a federal judge in Washington state issued a contradictory preliminary injunction blocking the FDA from pulling mifepristone within hours of Kacsmaryk’s ruling.

U.S. District Judge Thomas Rice in Spokane — a Barack Obama appointee — ruled in favor of a coalition of more than a dozen Democrat-led states in a lawsuit against the FDA. That case is within the historically left-leaning Ninth Circuit.

Follow @davejourno
Categories / Civil Rights, Health, Law

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