Mifepristone abortion pill case before Court of Appeal

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

Evelyn Hockstein Reuters

A federal appeals court Wednesday afternoon will hear arguments in a closely watched lawsuit aimed at removing the abortion pill mifepristone from the US market.

The hearing in the US 5th Circuit Court of Appeals in New Orleans comes 11 months after the Supreme Court ruled that abortion was no longer constitutional.

Justice Department attorneys representing the Food and Drug Administration and attorneys from an anti-abortion group called the Alliance for Hippocratic Medicine each have 40 minutes to present their case before the three-judge panel.

The outcome of the hearing, scheduled to begin at 2 p.m. ET, could determine whether women continue to have access to the now-standard method of abortion in the United States

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

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

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

The panel’s decision could be made at any time after the arguments. But regardless of what the verdict says, the losing side is sure to petition the Supreme Court to appeal the decision.

If the Supreme Court accepts the case for appeal, mifepristone will remain widely available until the Supreme Court makes a final decision on the case.

However, if it refuses to listen to an appeal, the 5th Circuit’s decision will be the final say on the fate of the drug.

challenge for mifepristone

The Alliance for Hippocratic Medicine sued the FDA in November in the US District Court for the Northern District of Texas, challenging the agency’s 2000 approval of mifepristone.

The group argued the agency failed to follow the correct process in approving mifepristone, claimed the drug was unsafe and asked a judge to order the drug’s withdrawal from the market.

These claims have been fiercely disputed by the FDA, leading medical associations, nearly half of US states and more than 200 members of Congress.

These companies argued in court filings that the FDA duly approved mifepristone and that the approval was based on extensive data demonstrating the drug’s safety and efficacy.

CNBC Health and Science

Read CNBC’s latest global health coverage:

But US Judge Matthew Kacsmaryk ruled in favor of the anti-abortion group’s claims and suspended FDA approval of mifepristone. His order would have halted sales of the drug nationwide pending the appeals process.

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

In April, a three-district judge panel ruled that the FDA’s approval of mifepristone stands pending the outcome of the DOJ’s appeal.

That panel said challenging the permit was likely precluded by the federal statute of limitations, though the judges made it clear their decision was based on “abridged scrutiny.”

But this body also blocked the mail delivery of the drug and imposed strict restrictions on the use of the drug.

Shortly thereafter, at the request of the Biden administration, the Supreme Court ordered that mifepristone be allowed to remain on the market without restrictions while the lawsuit was being fought in the 5th Circuit.

When the anti-abortion group wins

The Alliance Defending Freedom, an anti-abortion rights organization that represents the doctors group, is asking the three judges who will hear arguments on Wednesday to uphold in full Kacsmaryk’s order and halt sales of mifepristone nationwide.

The trio of judges differs from the 5th Circuit panel that issued the order last month that put some restrictions on the availability of mifepristone but kept the drug on the market.

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

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 take an entirely different direction, he said.

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

He said the Supreme Court will likely agree to take the case if the 5th Circuit panel votes to remove mifepristone from the US market.

Cohen argued that Supreme Court justices would take this position because a majority of them approved the DOJ’s request to keep mifepristone available without restrictions while litigation played out in the lower courts.

If the FDA wins

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

The previous 5th Circuit panel blocked mail delivery of mifepristone in April, reinstated the requirement that women see a doctor to get a prescription for the pill, and shortened the length of time women can take the drug from the 10th week. up to the seventh week of pregnancy.

The panel said in its ruling last month that the FDA’s earlier decision to relax its regulations on mifepristone would result in more women seeking emergency care due to serious complications from the drug.

The Justice Department said in its appeal that the panel misunderstood data showing the drug was safe.

DOJ attorneys noted in a court filing that sepsis and bleeding occur in only 0.2% of patients taking the drug, and the rate of blood transfusions or hospitalizations is 0.7% or less.

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

“Furthermore, pregnancy itself carries a significantly higher risk of serious adverse events, including a 14 times higher mortality rate than legal abortion,” the DOJ said.

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

He said the fact that the majority of judges have opted to keep mifepristone available while a lawsuit is pending in a lower court suggests they are not particularly sympathetic to the anti-abortion case.

And while the lawsuit raises questions the Supreme Court may eventually be interested in, he said the case against the FDA is a technical case that judges might prefer not to consider.