Appeals Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions

Less than a year after the Supreme Court declared it was ceding the matter of abortion to elected officials, the justices are poised to consider whether the most common method of ending pregnancies can be sharply curtailed in states where abortion remains legal, not just where it is illegal.

After a federal appeals court imposed several barriers to access to an abortion pill late Wednesday night, the Justice Department announced on Thursday that it would seek emergency relief from the justices, asking them to block the ruling while a fast-tracked appeal moved forward.

The appellate ruling, from a divided three-judge panel of the U.S. Court of Appeals for the Fifth Circuit in New Orleans, said the pill, mifepristone, could remain available while the lawsuit, filed against the Food and Drug Administration by anti-abortion groups, proceeded through the courts.

In its order, the panel partly rejected a ruling from Judge Matthew J. Kacsmaryk of the Northern District of Texas, who declared last week that the F.D.A.’s approval of mifepristone in 2000 was not valid, in essence saying that the drug should be pulled from the market.

But the panel blocked a series of steps the F.D.A. took in recent years to ease access to the drug — including allowing it to be sent through the mail and prescribed by health care providers who are not doctors.

The appellate court said its ruling would hold until the full case was heard on its merits.

But Thursday afternoon, a federal judge in another mifepristone lawsuit issued an order that required the F.D.A. not to limit access to the drug in much of the country.

That lawsuit, filed by Democratic attorneys general in 17 states and the District of Columbia, challenged extra restrictions the F.D.A. imposes on mifepristone. Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, last Friday blocked the agency from curbing the availability of mifepristone in those states.

On Thursday, he reaffirmed that order said that it “must be followed” by the F.D.A. “irrespective” of what the Fifth Circuit appeals court would do.

Legal experts said the dueling federal court orders could make it more likely that the Supreme Court will need to resolve the status of the abortion pill.

When the Supreme Court eliminated the constitutional right to abortion in June, overturning a half-century of precedents, it made a vow. Writing for the majority in Dobbs v. Jackson Women’s Health Organization, Justice Samuel A. Alito Jr. said that “the authority to regulate abortion must be returned to the people and their elected representatives.”

“Women on both sides of the abortion issue,” he wrote, should “seek to affect the legislative process by influencing public opinion, lobbying legislators, voting and running for office.” The early evidence suggests that supporters of abortion rights are winning those political battles.

By contrast, the new case, taking issue with an administrative agency’s scientific assessment of the safety of the pill, indicates that opponents of abortion continue to think that the judiciary is their most potent ally.

The Dobbs decision concerned the Constitution, while the appeals court’s ruling mostly turned on principles of administrative law. But the new case demonstrates that legal disputes over abortion will continue to engage the justices.

They will most likely rule on the Biden administration’s emergency application in a matter of days and may restore full access to the pill, endorse the restrictions outlined by the appeals court or suspend access entirely, as a federal judge in Texas did. The appeal will then proceed and probably return to the justices for a ruling on the merits, further embroiling them in a fight they said they had abandoned.

The case has attracted interest beyond the groups that usually weigh in on abortion cases. Hundreds of pharmaceutical industry leaders and investors issued a scathing condemnation of the ruling invalidating mifepristone’s approval and filed a brief supporting the F.D.A. in the case.

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they wrote in a statement on Monday. Leaving the fate of medicines in the hands of jurists, they argued, would have a chilling effect on drug development in the United States, reducing incentives for investment and innovation.

In its order, the appellate panel said the F.D.A.’s approval of mifepristone could stand because too much time had passed for the plaintiffs, a consortium of groups and doctors opposed to abortion, to challenge that decision. The court also seemed to take into account the government’s view that removing a long-approved drug from the market would have “significant public consequences.”

But the appellate court said that it was not too late for the plaintiffs to challenge a set of steps the F.D.A. took, beginning in 2016, that lifted restrictions and made it easier for more patients to have access to the pill.

The court also said that the government could not logically claim that the changes made since 2016 were crucial to the public, “given that the nation operated — and mifepristone was administered to millions of women — without them for 16 years” after the initial pill approval.

Such steps significantly expanded access to medication abortion, which is now used in more than half of pregnancy terminations in the United States. It usually involves taking mifepristone — which blocks a hormone that allows a pregnancy to develop — followed one or two days later by another drug, misoprostol, which causes contractions similar to a miscarriage.

The ruling would reinstate measures that required mifepristone to be prescribed and dispensed only by a doctor and picked up in person by the patient, who would have to visit the doctor three times during the medication abortion process.

Changes since 2016 also included the F.D.A.’s approval in 2019 of a generic version of mifepristone, manufactured by GenBioPro, whose product is now used by many telemedicine abortion services and clinics.

Evan Masingill, the chief executive of GenBioPro, said in a statement on Thursday: “In the United States, once a drug has been through the rigorous F.D.A. review process and received approval, federal law protects the right to market the drug. GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”

A lawyer for the plaintiffs, Erin Hawley, senior counsel for the Alliance Defending Freedom, a conservative Christian legal organization, said at a news media briefing on Thursday that “the Fifth Circuit’s decision is a significant victory for the doctors we represent, women’s health and every American who deserves an accountable federal government acting within the bounds of the law.”

Judge Kacsmaryk, a Trump appointee who has written critically of the Roe v. Wade decision, had stayed his order for seven days to give the F.D.A. time to appeal. On Monday, the F.D.A. asked the appeals court to extend that stay, and the judges partly granted that request.

In the decision, which came just before midnight on Wednesday, two Trump-appointed judges voted to reimpose some of the restrictions that the F.D.A. had eased. The third judge, appointed by President George W. Bush, said she would essentially have granted the full request. All of those restrictions were temporarily reinstated.

The 42-page appeals court opinion appeared to accept several of the claims of the anti-abortion plaintiffs and used some of the terminology of abortion opponents, referring to medication abortion as “chemical abortion” and in one instance referring to a fetus or embryo as “an unborn child.”

In their lawsuit, the abortion opponents claim that mifepristone is unsafe, causing “cramping, heavy bleeding and severe pain,” and that the F.D.A. has ignored safety risks and never adequately evaluated the scientific evidence.

The F.D.A. vigorously disputes this claim, as do mainstream medical organizations. They say that bleeding and cramping are normal consequences of the process, a sign that the pregnancy tissue is being expelled, and cite years of scientific studies that show that serious complications are rare, resulting in less than 1 percent of patients needing hospitalization. The F.D.A. applies a special regulatory framework to mifepristone, meaning that it has been regulated much more strictly and studied more intensively than most other drugs.

In seeking a stay of Judge Kacsmaryk’s ruling, lawyers from the Justice Department, representing the F.D.A., wrote, “There is no basis in science or fact for plaintiffs’ repeated claims that mifepristone is unsafe when used in the manner approved by F.D.A.”

The appeals court did not evaluate all of the safety arguments in the case, but it said that the F.D.A. “cannot deny that serious complications from mifepristone” occur and said that the agreement form that the agency requires patients to sign stipulates that the drug can carry risks. The court also said that the F.D.A. was incorrect in saying that mifepristone was comparable in safety to ibuprofen. “F.D.A.’s own documents show that mifepristone bears no resemblance to ibuprofen,” the court said.

The appeals court also seemed to agree with the plaintiffs that a 19th-century law called the Comstock Act prevents the mailing of drugs used for abortions. The Justice Department said in a recent memo that the act prohibits mailing the pills only if the sender knows they will be used for an illegal abortion, not if the patient is in a state where abortion is legal.

The appeals court wrote that “merely by knowingly making use of the mail for a prohibited abortion item” would violate that law.

Mike Ives contributed reporting.