Appeals court to hold hearing on future availability of abortion pill mifepristone

A federal appeals court in Louisiana is scheduled to hear arguments Wednesday in a case that could help decide the future availability of what is now the most commonly used abortion pill in the U.S.

Attorneys for the Food and Drug Administration and the drug's manufacturer will try to persuade a three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans not to roll back accessibility to mifepristone.

“Americans have been safely using mifepristone for over two decades. More than five million women in the United States have used mifepristone to terminate their pregnancies, as have millions of other women around the world. And study after study has shown that serious adverse events are exceedingly rare,” the FDA's filing said.

The challengers — a group of doctors and medical professionals who oppose abortion — argue the FDA's approval of the drug in 2000 was "arbitrary and capricious" and should be revoked.

The group, the Alliance for Hippocratic Medicine, contends the drug is not as safe as the FDA has determined. "The crux of Plaintiffs’ arguments is that FDA’s judgment was not based on the required scientific evidence. The agency’s position—that no court is worthy of checking FDA’s work—reeks of hubris," the challengers said in a court filing.

The group also argued that changes the FDA made in recent years — allowing the drug to be sent to patients by mail and expanding the pool of eligible patients — should be reversed. "These actions do not reflect 'scientific' judgment but politically driven decisions to unlawfully push a dangerous regimen," the group wrote.

U.S. District Judge Matthew Kacsmaryk in Texas sided with the challengers last month, suspending the FDA’s 2000 approval of mifepristone. Kacsmaryk, a Trump appointee, cited in part what he called "evidence indicating FDA faced significant political pressure" to approve the drug more than two decades ago.

The Justice Department, which is representing the FDA, filed an emergency appeal of Kacsmaryk's order to the 5th Circuit, arguing the ruling “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”

The government also argued that pulling a drug's approval after more than two decades would cause tumult in the pharmaceutical industry. "Allowing plaintiffs to challenge mifepristone’s approval at this late date, after the drug has been on the market for over two decades, would be profoundly disruptive," the lawyers argued.

In an emergency ruling last month, a three-judge panel agreed that at this stage of the litigation the drug's initial approval should not be revoked but agreed with Kacsmaryk that the challengers were likely to prevail on their other claims, including rolling back the mail provision and another that allowed the pills to be prescribed to women at up to 10 weeks’ gestation instead of the previous seven weeks.

The Supreme Court weighed in on April 21, saying the status quo should remain in place until the appeals process plays out in the 5th Circuit, meaning that for now access to mifepristone is the same as it was before Kacsmaryk's ruling.

The panel at Wednesday's hearing consists of different judges from the ones who took up the emergency application last month. Two of the judges — Cory Wilson and James Ho — were nominated by former President Donald Trump, while the third, Jennifer Walker Elrod, was nominated by former President George W. Bush.

All three have histories of supporting restrictions on abortion, The Associated Press reported this week. Ho called abortion a "moral tragedy" in a 2018 ruling.

Lawyers for the Alliance for Hippocratic Medicine did not respond to a request for comment and attorneys for mifepristone’s manufacturer, Danco Laboratories, declined comment on the coming hearing. The FDA did not respond to a request for comment, and the Justice Department declined to comment.

The fight also involves a court case in Washington state, where a federal judge last month issued a preliminary injunction barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”

That ruling applies only to Washington, D.C., and the 17 liberal-leaning states that sued in February challenging the FDA’s regulations over the drug, arguing they were too cumbersome.

The judge in that case, Thomas O. Rice, an Obama appointee, issued a subsequent order specifying that the FDA cannot make any moves to comply with the 5th Circuit’s decision in the states affected by the case before him, increasing the odds for an eventual showdown at the Supreme Court over mifepristone.

The challenges to the drug come on the heels of the Supreme Court's 5-4 ruling last summer overturning the landmark Roe v. Wade decision, which had guaranteed a constitutional right to abortion for the previous 50 years.

In its filing, the Alliance for Hippocratic Medicine said the FDA's actions expanding the availability of mifepristone in recent years "subvert the promise" of last year's Supreme Court ruling.

Mifepristone is still available in the 37 states that legally allow some form of medication abortion. Experts have said that if the FDA’s approval of the drug is revoked, anyone involved in manufacturing or distributing it could face legal risk.