Appeals Court upholds abortion drug but there are restrictions

 

Appeals Court Upholds Legality of Abortion Pill but With Significant Restrictions

The restrictions, which would prevent mifepristone from being mailed to patients and would require in-person doctor visits, are on hold until the Supreme Court weighs in.

A federal appeals court panel said on Wednesday that the abortion pill mifepristone should remain legal in the United States but with significant restrictions on patients’ access to it, setting up a showdown before the Supreme Court on the fate of the most common method of terminating pregnancies.

The decision, which would prohibit the pill from being sent through the mail or prescribed through telemedicine, is the latest development in a closely watched lawsuit that seeks to remove abortion pills entirely from the market by invalidating the Food and Drug Administration’s 23-year-old approval of mifepristone. But for now, the ruling will have no real-world effect: In April, the Supreme Court said mifepristone would have to remain available under the current rules until the appeals process concludes.

Anti-abortion groups filed the lawsuit last year, several months after the Supreme Court had overturned the constitutional right to abortion. Shortly after the appeals court ruled on Wednesday, the Justice Department said it would ask the justices to hear the case.

The court is likely to act in the coming months. It could deny review, leaving in place the appeals court’s ruling, curbing but not eliminating access to the pill. Or it could agree to hear the appeal, returning to contested terrain that at least some of the justices might prefer to avoid.

The justices will be navigating against the backdrop of their decision last year overturning Roe v. Wade, a ruling that led to a sharp drop in the court’s approval ratings, questions about its legitimacy and a political windfall for Democrats.

In that 6-to-3 decision, the conservative majority made a kind of promise, saying that the court was ceding the question of the availability of abortion “to the people and their elected representatives.” That could indicate a reluctance to hear a new abortion case.

On the other hand, a question of such significance would seem to warrant a ruling from the nation’s highest court. The case could also have implications beyond abortion, calling into question the F.D.A.’s regulatory authority over other drugs.

In the new ruling, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit upheld part of a sweeping decision issued in April by a federal judge in Texas. That decision, by Judge Matthew J. Kacsmaryk, who was appointed by President Donald J. Trump and has publicly espoused anti-abortion views, effectively nullified the F.D.A.’s approval of the pill.

But the appeals court decision kept the F.D.A.’s approval in place. It also kept in place a later F.D.A. approval of the generic version of the drug, which now accounts for about two-thirds of the mifepristone sold in the United States.

The main impact of the appeals court’s decision, if it is upheld by the Supreme Court, would be to reverse changes made by the F.D.A. in recent years that greatly increased access to the pill, partly by allowing some health care providers who are not doctors to prescribe mifepristone and allowing patients to obtain the pill without visiting a provider in person. The appeals court ruling would mean that patients would have to make three visits to a doctor to get mifepristone and could not receive it in the mail.

The ability for patients to use telemedicine and get the prescribed pills shipped to them has significantly expanded the use of medication abortion, which is now used in more than half of pregnancy terminations in the United States.

The lawsuit was filed against the F.D.A. by several anti-abortion doctors and a consortium of anti-abortion medical groups called the Alliance for Hippocratic Medicine, which was incorporated in Amarillo, Texas, soon after Roe had been overturned. The case was filed in Amarillo.

The appeals court majority wrote that the statute of limitations appeared to bar a challenge to the F.D.A.’s initial approval of mifepristone in 2000. It said that the approval of generic mifepristone in 2019 should also remain in effect because the plaintiffs had not shown that they had been adversely affected by that approval.

Judge Jennifer W. Elrod, who was appointed by President George W. Bush, wrote the majority opinion, which was joined by Judge Cory T. Wilson, who was appointed by Mr. Trump. The decision said that changes the F.D.A. had made in 2016 and 2021 should be rolled back.

“In loosening mifepristone’s safety restrictions, F.D.A. failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Elrod wrote. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”

Among the changes the F.D.A. made in 2016 were to allow nurse midwives and certain other providers, not just doctors, to prescribe mifepristone and to reduce the required number of in-person visits to one. Another change was to extend the time frame for mifepristone use, authorizing it until 10 weeks into pregnancy instead of seven weeks. (The appeals court decision would have less practical impact on that time frame, however, because physicians in most states can legally use medical discretion to prescribe mifepristone until 12 weeks into pregnancy, as there is scientific evidence that abortion pills are safe and effective within that time frame.)

In 2021, the F.D.A. lifted the in-person dispensing requirement altogether, allowing abortion pills to be prescribed via telemedicine and mailed to patients. That decision paved the way for numerous telemedicine abortion services, which have increasingly been supplying the pills to patients.

More than five million women in the United States have used mifepristone to terminate their pregnancies, and many studies have found it to be highly safe and effective. Years of research has shown that serious complications are rare, resulting in fewer than 1 percent of patients needing hospitalization, medical experts have said. 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. The drug is also approved for use in dozens of other countries.

In the United States, the medication abortion protocol typically 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 to expel pregnancy tissue.

If access to mifepristone were limited, abortion providers might have to rely solely on misoprostol, which can be used on its own but is somewhat less effective and more prone to causing side effects.

Judge James C. Ho, another Trump appointee on the appeals court panel, wrote a caustic partial dissent, saying he would invalidate the approval of mifepristone in 2000.

“Scientists have contributed an enormous amount to improving our lives,” Judge Ho wrote. “But scientists are human beings just like the rest of us. They’re not perfect. None of us are. We all make mistakes. And the F.D.A. has made plenty.”