Appeals court hears arguments in abortion pill case

A panel of three federal court judges heard arguments Wednesday in a case that could force a major abortion pill off the market nationwide, including in states where abortion is legal.

The case hinges on whether the Food and Drug Administration's approval of mifepristone, as well as subsequent actions making the drug easier to obtain, should be rolled back.

Abortion rights advocates have said the lawsuit has the potential to decimate nationwide access to medication abortion, which makes up over half of all abortions in the United States.

The panel of judges on the New Orleans-based 5th US Circuit Court of Appeals, considered among the most conservative in the country, is the latest federal court to weigh in on the case after a federal judge in Texas ordered a hold on FDA approval of mifepristone in April. The ruling was stayed pending appeal.

The Supreme Court last month decided mifepristone would remain available as the case made its way through the court system.

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.

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What happens now in mifepristone case?

The three-judge panel won't issue a ruling on the case immediately. Once a decision is made, it is likely to be appealed to the U.S. Supreme Court.

Justice Department attorneys defend FDA approval

U.S. Department of Justice attorneys representing the FDA urged the panel to overturn last month's ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, that sought to suspend mifepristone's FDA approval.

During an opening statement by Justice Department attorney Sarah Harrington, judges were quick to push back, including at Harrington's description of the case as "unprecedented." Judge James Ho said challenging the FDA's expertise in court was not unprecedented, to which Harrington said, "But I don’t think there’s ever been any court that has vacated FDA’s determination that a drug is safe to be on the market."

Harrington also argued that the doctors bringing the lawsuit have not shown they've been directly harmed by others prescribing mifepristone or forced to provide care that violates their beliefs. The judges also pushed back on this assertion and raised concerns about the safety of mifepristone, citing a study widely denounced by medical experts.

Justice Department attorneys and lawyers representing drugmaker Danco Laboratories argued in support of the safety and effectiveness of mifepristone and said the plaintiffs "used false math" in their case. The defendants also said withdrawing FDA approval will have ripple effects on dozens of other FDA-approved drugs.

On Friday, April 21, 2023, the Supreme Court halted restrictions that would have limited access to the abortion pill mifepristone, resolving a massive and fast moving conflict over access to the drug while the underlying lawsuit is decided.
On Friday, April 21, 2023, the Supreme Court halted restrictions that would have limited access to the abortion pill mifepristone, resolving a massive and fast moving conflict over access to the drug while the underlying lawsuit is decided.

Anti-abortion groups push to reverse FDA approval of mifepristone

Meanwhile, attorneys representing the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups led by the Alliance Defending Freedom, claimed mifepristone is unsafe and its approval should be reversed.

"This case is not about ending abortion, it’s about ending a particularly dangerous type of abortion," said Erin Hawley, senior counsel for Alliance for Defending Freedom.

Hawley said doctors have "been forced to participate in and complete elective abortions, contrary to their consciences."

The defendants have argued that mifepristone rarely results in complications and that doctors can refuse to participate in procedures they believe are contrary to their consciences.

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Federal court judges have history of supporting abortion restrictions

The three judges that make up the panel — Ho, Jennifer Walker Elrod, and Cory Wilson — each have a history of supporting abortion restrictions.

Elrod was among 5th Circuit judges who allowed Texas to temporarily ban abortions as the COVID-19 pandemic took hold. She co-authored an opinion that upheld a 2021 Texas law outlawing an abortion method commonly used in the second trimester. And she was part of a panel that refused to require Louisiana to issue a license for a Planned Parenthood abortion clinic in New Orleans.

Ho, a former clerk for Supreme Court Justice Clarence Thomas, was nominated to the 5th Circuit by President Donald Trump in 2017. In a 2018 opinion, he called abortion a "moral tragedy." In the Dobbs v. Jackson Women's Health Organization case, which went on to lead to the overturning of Roe v. Wade, Ho criticized a lower court for displaying "an alarming disrespect for the millions of Americans who believe … that abortion is the immoral, tragic, and violent taking of innocent human life.."

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Wilson, nominated to the court by Trump in 2020, supported anti-abortion measures while serving in the Mississippi House from 2016 to 2019, including voting to stop Medicaid funding to Planned Parenthood facilities in the state and to prohibit most abortions after 15 weeks.

"This is one of the worst panels of judges that could have been assembled for those who believe that mifepristone should remain on the market," said Jennifer Dalven, director of the ACLU Reproductive Freedom Project, adding that "we have to be prepared for all possible outcomes."

"If the plaintiffs were to succeed in this case, the effects would be extraordinarily dangerous and far-ranging," Dalven said. "It would be devastating for patients seeking abortion and miscarriage care and would be catastrophic for Americans in terms of their access to a wide range of critical medications."

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Is mifepristone safe?

As the case has ricocheted through the court system, leading medical associations and health experts have pointed to mifepristone's decades-long safety record and studies showing it to be safer than common drugs such as Tylenol and Viagra.

The U.S. Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone safe and effective for abortion and miscarriage care.

The drug has been discussed in more than 780 medical reviews and used in more than 630 published clinical trials, according to the AMA. It has also long been approved for use in 19 countries. In France and China, mifepristone was approved for abortion care in 1988, years before the FDA approved the drug in 2000.

"This medication has been used safely and effectively in the United States by over 5 million pregnant people for the past 23 years and today accounts for more than half of all abortions in the United States," said Ushma Upadhyay, a professor of obstetrics and gynecology at the University of California, San Francisco, who studies contraception and abortion care. "Study after study demonstrates the strong safety rating of over 99%."

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Contributing: The Associated Press

This article originally appeared on USA TODAY: Abortion pill case: Judges hear arguments in mifepristone lawsuit