Access to abortion pill mifepristone at stake in federal appeals court hearing

Mifepristone, the first medication in a medical abortion, is prepared for a patient at Alamo Women’s Clinic in Carbondale, Illinois, April 20, 2023.

Evelyn Hockstein | Reuters

A federal appeals court will hear arguments Wednesday afternoon in a closely watched lawsuit that seeks to pull the abortion pill mifepristone from the U.S. market.

The hearing at the U.S. 5th Circuit Court of Appeals in New Orleans comes 11 months after the Supreme Court ruled there was no longer a federal constitutional right to abortion.

Lawyers from the Department of Justice, who are representing the Food and Drug Administration, and attorneys for a group of anti-abortion doctors called the Alliance for Hippocratic Medicine each will have 40 minutes to present their case before the three-judge panel.

The outcome of the hearing, set to begin at 2 p.m. ET, could determine whether women will continue to have access to what has become the common method to terminate a pregnancy in the U.S.

Mifepristone, used in combination with another drug, misoprostol, accounts for about half of all abortions domestically.

The judges who will hear the arguments all were nominated by Republican presidents.

Judges James Ho and Cory Wilson were appointed by Donald Trump. Judge Jennifer Elrod was appointed by George W. Bush.

The panel’s ruling could come at any time after the arguments. But regardless of what that ruling says, the losing side is certain to ask the high court to hear an appeal of the decision.

If the Supreme Court accepts the case for appeal, mifepristone will remain widely available until the high court issues a final decision in the case.

But if it refuses to hear an appeal, the 5th Circuit decision will be the final word on the drug’s fate.

Challenge to mifepristone

The Alliance for Hippocratic Medicine in November sued the FDA in U.S. District Court for the Northern District of Texas, challenging the agency’s authorization of mifepristone, which occurred in 2000.

The group argued the agency did not use the correct process to approve mifepristone, claimed the medication is unsafe, and asked a judge to order the drug withdrawn from the market.

Those claims were strongly disputed by the FDA, leading medical associations, nearly half the U.S. states, and more than 200 members of Congress.

Those entities argued in court filings that the FDA properly approved mifepristone and that the approval was based on extensive data that supported the medication’s safety and effectiveness.

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But U.S. Judge Matthew Kacsmaryk ruled in favor of the anti-abortion group’s claims and suspended the FDA approval of mifepristone. His order would have halted sales of the medication nationwide pending appeal.

Days later, the DOJ appealed Kacsmaryk’s decision to the 5th Circuit, which handles cases arising from the Northern District of Texas.

In April, a three-judge panel at the circuit said that FDA’s approval of mifepristone would remain in place pending the outcome of the DOJ’s appeal.

That panel said the challenge to the approval likely is barred by federal statute of limitations, although the judges made clear that their determination was based on an “abbreviated review.”

But that panel also blocked mail delivery of the drug and imposed tight restrictions on how the medication is used.

Soon afterward, the high court, acting at the request of the Biden administration, ordered mifepristone to remain on the market without restrictions while the legal battle played out in the 5th Circuit. 

If the anti-abortion group wins

The Alliance Defending Freedom, an anti-abortion legal organization representing the doctors’ group, is asking the three judges who will hear Wednesday’s arguments to uphold Kacsmaryk’s order in full, halting sales of mifepristone nationwide.

The trio of judges is different than the 5th Circuit panel that last month issued the order that imposed some restrictions on the availability of mifepristone while keeping the drug on the market.

Glenn Cohen, a former DOJ lawyer, said the current three-judge panel is not bound by the prior panel’s decision in April.

The new panel could issue an order that goes further or less far than the restrictions imposed in April, said Cohen, who is now a professor at Harvard Law School. Or the panel could go in a different direction altogether, he said.

Cohen filed a brief at the 5th Circuit with other drug law experts in support of the FDA’s position.

He said the Supreme Court will likely agree to take the case if the 5th Circuit panel decides to pull mifepristone from the U.S. market.

Cohen argued the high court justices would take that position because a majority of them had approved the DOJ’s request to keep mifepristone available without restrictions as lower-court litigation played out.

If the FDA wins

The DOJ is asking the 5th Circuit to reverse Kacsmaryk’s sweeping order and keep mifepristone available under the FDA’s current regulations. The FDA now allows women to obtain mifepristone without visiting a doctor in person and can receive the prescription drug through the mail.

The prior 5th Circuit panel in April had blocked mail delivery of mifepristone, reimposed a requirement that women visit doctors to be prescribed the pill, and shortened the time period when women can take the drug from the 10th week of pregnancy to the seventh week.

That panel in its ruling last month said the FDA’s prior decision to loosen its regulations on mifepristone would result in more women seeking emergency care due to serious complications from the medication.

The Justice Department, in its appeal, said the panel misunderstood data that shows that the medication is safe.

DOJ lawyers noted in a court filing that sepsis and hemorrhage occurs in just 0.2% of patients who take the drug, and the rates of blood transfusion or hospitalization are 0.7% or less.

“And study after study has shown that when mifepristone is taken consistent with its approved conditions of use, serious adverse events are ‘exceedingly rare,'” the DOJ said in its brief to the panel that will hear Wednesday’s arguments.

“In addition, pregnancy itself entails a significantly higher risk of serious adverse events, including a death rate 14 times higher than that associated with legal abortion,” the DOJ said.

Cohen believes the Supreme Court is less likely to take the case if the government wins at the 5th Circuit and the anti-abortion group appeals the ruling.

He said the fact that a majority of justices chose to keep mifepristone available while lower-court litigation plays out suggests they are not particularly sympathetic to the anti-abortion doctors’ case.

And while the lawsuit raises issues the Supreme Court might be interested in at some point, he said the case against the FDA is a technical one that the justices might prefer to pass on reviewing.

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