© Allen G. Breed/AP
The U.S. Court of Appeals for the 5th Circuit will consider this week the fate of the abortion pill mifepristone. (Allen G. Breed/ AP)

NEW ORLEANS — A federal appeals court on Wednesday seemed prepared to limit access to a key abortion medication first approved more than two decades ago, expressing deep skepticism that the government followed the proper process when it loosened regulations to make the pill more readily available.

A panel of three judges, all of whom have previously supported other types of abortion restrictions, peppered lawyers for the government and the drug manufacturer with questions about why the Food and Drug Administration has allowed mifepristone to be prescribed by a medical professional other than a doctor and sent directly to patients by mail.

The judges also appeared to embrace the suggestion that restoring prior restrictions on mifepristone would mean fewer women would need emergency care after using medication to terminate a pregnancy. Serious side effects occur in less than 1 percent of such abortions.

Judge James C. Ho rejected the government’s argument that the court should not second-guess the expertise of the FDA, which first approved mifepristone in 2000. The medication is part of a two-drug regimen used in more than half of U.S. abortions, though the second drug — misoprostol — can also be used on its own to terminate a pregnancy.

“I don’t understand this theme that FDA can do no wrong,” Ho said. “We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts.”

Judge Jennifer Elrod took the unusual step of chastising the drug company’s lawyer for pointed language in court filings that criticized an April ruling by U.S. District Judge Matthew Kacsmaryk of Texas that would outright suspend FDA approval of the drug.

Wednesday’s hearing at the conservative U.S. Court of Appeals for the 5th Circuit was to consider an appeal of that ruling by lawyers for the Justice Department, representing the FDA, and the drug manufacturer Danco Laboratories. Revoking approval of mifepristone, they have said in court filings, would also jeopardize access to non-abortion drugs and more broadly impact medical research and innovation.

The judges randomly assigned to the case are Ho and Judge Cory T. Wilson — both nominated by President Donald Trump — and Elrod, a nominee of President George W. Bush. Regardless of how they rule, mifepristone will remain available under existing regulations until the case is resolved, probably by the Supreme Court.

The legal battle over abortion medication has intensified in the months since the Supreme Court overturned Roe v. Wade’s constitutional right to abortion, a decision that spurred multiple states to further limit or ban the procedure. Lawmakers in North Carolina voted this week to significantly narrow the window for legal abortions in the state, with more restrictions expected to pass soon in Nebraska and South Carolina.

A brief history of the abortion pill mifepristone

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Antiabortion advocates behind the mifepristone lawsuit told the court that the FDA improperly cleared the medication for use in 2000, then later removed safeguards to expand access to the pill. Attorney Erin Hawley said the court should reconsider initial approval of the drug, arguing that looser regulations have fundamentally altered the patient experience. In the small percentage of cases in which the medication does not terminate a pregnancy, she said, the antiabortion doctors she represents are “cleaning up the mess that’s left.”

“This case is not about ending abortion, it’s about ending a particularly dangerous type of abortion,” said Hawley, senior counsel for the Christian conservative legal group Alliance Defending Freedom.

Wilson seemed to share those concerns.

“What the FDA has done in making this more available and doing it by mail order and removing the doctor visits — as well as the requirement that the prescriber be a doctor — is you’ve made it much more likely that patients are going to go to emergency care,” he said.

Justice Department lawyer Sarah Harrington disagreed.

“I don’t think any of that is right and hasn’t been borne out by the evidence,” she said.

Lawyers for the government have emphasized that the FDA relied on dozens of studies involving thousands of patients before approving mifepristone, which has since been used by more than 5 million women. Courts should not “second guess FDA’s scientific judgments about the safety of a drug based on anecdotal allegations, speculative harm and flawed studies,” they said in court filings.

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The lawsuit was brought by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others, and filed in Amarillo, Tex., where Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge.

In April, Kacsmaryk took the unprecedented step of suspending the FDA’s approval of mifepristone, agreeing with the plaintiffs’ claims that the FDA did not sufficiently consider safety concerns. The language of his decision echoed terminology used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”

During the hearing Wednesday, Elrod called out the lawyer for the drug company, Jessica Ellsworth, for lobbing what she described as personal attacks on Kacsmaryk in her briefs. Reading from Danco’s filing, the judge objected to the characterization of Kacsmaryk’s ruling as an “unprecedented judicial assault” and the product of a “relentless one-sided narrative.”

Those are comments, Elrod said, that “we normally don’t see from learned counsel.” The judge offered the lawyer an opportunity to recant.

Ellsworth responded that Danco was criticizing Kacsmaryk’s analysis in the case, not the judge himself. The remarks, she said, were not “intended as any kind of personal attack.”

In general, the lawyer for the antiabortion groups, Hawley, was questioned far less aggressively by the judges than the attorneys on the other side. Hawley spoke for extended stretches uninterrupted. At the end of her arguments, the judges did not have any additional questions for her, so she wrapped up without using all of her allotted time.

In an initial review of Kacsmaryk’s ruling, a separate three-judge panel of the 5th Circuit declined to suspend approval of mifepristone but reversed actions taken by the FDA since 2016 to loosen restrictions on how to access the medication. Those actions included extending its approved use through 10 weeks of pregnancy instead of seven and allowing patients to receive the drug through the mail.

The Supreme Court then temporarily blocked those restrictions from the appeals court, opting to leave the current FDA regulations for mifepristone in place while the litigation continues.

Much of the discussion Wednesday centered on the claim by the Justice Department and Danco that the challengers had no legal right — or standing — to file the lawsuit because they were not directly harmed by the FDA’s approval of the abortion pill.

The antiabortion doctors “do not prescribe mifepristone. They do not provide abortions. No specific doctor faces irreparable harm” because their claims “rest on cascading chains of speculation about potential future events,” Ellsworth said in a court filing.

Harrington said the antiabortion doctors’ “carefully worded” affidavits do not actually allege they have had to provide care that violates their religious beliefs or consciences.

But the judges pushed back hard on Harrington’s assertions, with one saying she was trying to “split words” to get the lawsuit thrown out. They seemed unlikely to agree that the challengers do not have standing, and therefore likely to reach the merits of the arguments against FDA approval.

The judges also touched briefly on Hawley’s argument that shipping abortion medication violates a 150-year-old law, the Comstock Act, that most legal experts considered obsolete. The law prohibits the mailing of any drug “intended for producing abortion.” The Biden administration has rejected that interpretation as outdated, and asserted in a recent legal memo that mailing mifepristone is permitted when the sender believes the drug will be used lawfully, in states where abortion is permitted.

Allowing the pill to be sent by mail has made it more difficult, however, for states to enforce abortion bans passed since the end of Roe — a point that Hawley made Wednesday.

The justices returned to “the people the power to protect women’s health, unborn life, and the integrity of the medical profession by regulating abortion,” she said in a court filing. “Yet, the considered judgments of states that have chosen to do so are rendered meaningless by FDA’s mail-order abortion scheme.”

The cases are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.

Kitchener and Stein reported from Washington. Azi Paybarah and Robert Barnes contributed to this report.