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Federal judge issues ruling suspending FDA approval of abortion pill

WASHINGTON — A federal judge in Texas ruled April 7 to suspend the U.S. Food and Drug Administration’s approval of a medication abortion pill, additionally granting a seven-day pause for his ruling before it would go into effect to allow the federal government to appeal and seek emergency relief.

The Good Friday ruling comes amid a lawsuit by a coalition of pro-life opponents of the drug mifepristone, the first of two drugs used in a medication or chemical abortion. The groups are seeking for the FDA’s approval of the drug to be revoked, arguing the government violated its own safety standard in approving the drug more than two decades ago.

U.S. District Judge Matthew Kacsmaryk’s ruling marks the most significant abortion-related court ruling since the Supreme Court issued its Dobbs v. Jackson Women’s Health Organization decision last year which overturned prior rulings by the high court that make abortion access a constitutional right.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote 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.”

The American Association of Pro-Life Obstetricians and Gynecologists, plaintiffs in the lawsuit challenging mifepristone, said in an April 7 statement “today’s ruling in the US District Court for the Northern District of Texas is a victory for all our patients.”

“The FDA began a pattern of prioritizing the interests of the abortion industry over the health and safety of our nation’s women and girls 23 years ago by illegally and recklessly approving dangerous drugs for use in chemical abortions, and then continuing to remove safeguards for women,” the statement said. “Today’s ruling places women’s welfare back at the forefront of the conversation on this issue. Our patients deserve excellent healthcare and fully informed consent; this decision helps ensure they receive that.”

The Catholic Church teaches that all human life is sacred and must be respected from conception to natural death and as such opposes direct abortion as an act of violence that takes the life of the unborn child.

If Kacsmaryk’s ruling goes into effect after the seven day pause, it would issue a nationwide injunction on the sale of mifepristone, as requested by the plaintiffs, which would affect even U.S. states where abortion is legal and the drug is permitted under state law. However, the federal government indicated it will appeal the ruling.

Shortly after Kacsmaryk issued his ruling, another federal judge in Washington, Thomas Rice, ruled the opposite, blocking the FDA from “altering the status quo” on the drug and stating the FDA must keep medication abortion drugs available.

The 5th U.S. Circuit Court of Appeals is expected to consider the conflict between the two judge’s rulings within the seven-day window.

In a statement, Attorney General Merrick Garland said the Justice Department “strongly disagrees” with Kacsmaryk’s ruling and “will be appealing the court’s decision and seeking a stay pending appeal.”

“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Garland said. “The department will continue to defend the FDA’s decision.”

Garland added the department would also review Rice’s ruling and is “committed to protecting Americans’ access to legal reproductive care.”

Even if mifepristone is pulled from shelves, another drug used in combination for medication abortions, called misoprostol, would still be available. Misoprostol is sometimes prescribed by doctors for early miscarriage, and the FDA has not approved the drug for inducing an abortion on its own.

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