Federal judge issues Good Friday ruling suspending FDA approval of abortion pill

A box of medication used to induce abortion, known generically as mifepristone and by its brand name Mifeprex, is seen in an undated handout photo. A federal judge in Texas ruled April 7 to suspend the U.S. Food and Drug Administration’s approval of the medication abortion pill. (OSV News Photo courtesy of Danco Laboratories)

By Kate Scanlon

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.”

Jeanne Mancini, president of the national March for Life, called the ruling “a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs.”

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.

However, Alexis McGill Johnson, president and CEO of the Planned Parenthood Federation of America, said in an April 7 statement that Kacsmaryk’s ruling “blocking the FDA’s approval of mifepristone is an outrage and exposes the weaponization of our judicial system to further restrict abortion nationwide.”

McGill Johnson argued that while “access to mifepristone remains safe” for the time being, “we should all be enraged that one judge can unilaterally reject medical evidence and overrule the FDA’s approval of a medication that has been safely and effectively used for more than two decades.”

Dr. Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, and Dr. Maureen G. Phipps, ACOG’s CEO, said in a joint statement the decision “by a sole federal district judge in Texas to overturn FDA approval of mifepristone is a grievous legal overstep into America’s well-established regulatory system.”

“The decision itself betrays the bias and prejudice that informed its rhetoric, which deliberately ignores decades of evidence-based scientific data and eschews clinically appropriate language about mifepristone, a critical medication used for both abortion and miscarriage management,” the statement said.

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 of Kacsmaryk’s order.

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.

In January, the FDA eased restrictions on the sale of mifepristone, permitting its sale at retail pharmacies for the first time. The decision followed the U.S. Supreme Court’s Dobbs decision last year that struck down its previous 1973 Roe v. Wade decision, after which states moved to restrict or broaden abortion access.

“The FDA approved Mifeprex (mifepristone) more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use,” the agency said on its website.

Proponents of the use of mifepristone for abortion argue the court should keep the FDA regulations in place.

On its website as of March 24, the FDA states that mifepristone “is safe when used as indicated and directed” through 10 weeks gestation. The agency’s adverse reaction guidelines for the drug state that “serious and sometimes fatal infections and bleeding occur very rarely.”

But opponents of mifepristone say those risks are more common and more dangerous than proponents of the drug say.

“Major international studies show chemical abortion carries four times the risk for many severe, even life-threatening, complications as compared to surgical abortion,” Mancini said. “This action by the court will save lives and ensure that the health and safety of women and girls is not compromised for the sake of advancing a pro-abortion political agenda.”

Dr. Ingrid Skop, a board-certified OB-GYN who has practiced in Texas for nearly 30 years, and a senior fellow and director of medical affairs at Charlotte Lozier Institute who has been a critic of mifepristone, said in a statement, “Pregnancy is not an illness.”

“Children are our future,” Skop said. “These are things the vast majority of Americans agree on — except for the FDA, which ditched common sense, ignored its own rules and bypassed important safeguards when approving the abortion pill … the FDA put politics ahead of science, putting women and girls at risk.”

As the ruling was issued, Susan B. Anthony Pro-Life America released a poll conducted on its behalf by CRC research showing that a majority of Americans, 62%, said they doubt the safety of the drug despite being on the market for two decades.

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