A federal appeals court ruled late Wednesday that the abortion pill mifepristone could remain available, but the judges blocked the drug from being sent to patients through the mail and rolled back other steps the government had taken to ease access in recent years.
In its order, a three-judge panel for the Fifth Circuit partially overruled Judge Matthew J. Kacsmaryk of the Northern District of Texas, who last week declared that the Food and Drug Administration’s approval of mifepristone in 2000 was not valid, in essence saying that the drug should be pulled from the market.
The appellate court said its ruling would hold until the full case is heard on its merits.
In its order, the appellate panel said the Food and Drug Administration’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 Push to Restrict Abortion Pills
A federal judge in Texas invalidated the F.D.A.’s approval of an abortion pill, mifepristone. The decision could make it more difficult for patients to obtain abortions.
The court also said that the government could not logically claim that the changes made since 2016 “were so critical to the public, given that the nation operated — and mifepristone was administered to millions of women” before the old restrictions were eased.
Those changes approved use of the pill for up to 10 weeks into pregnancy instead of seven weeks, allowed it to be prescribed by some health providers other than doctors and permitted mifepristone to be mailed to patients instead of requiring it to be picked up from a health care provider in person.
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.
Judge Kacsmaryk, who was appointed by President Donald J. Trump and 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. had asked the appeals court to extend that stay, and the judges partly granted that request just before midnight on Wednesday.
In the decision, 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. The Justice Department is likely to appeal the order to the Supreme Court.
As conservative states began enacting bans on abortion after the Supreme Court overturned the national right to abortion last year, an increasing number of patients have sought the pills, some traveling to states where abortion is legal to get them, others receiving them through the mail after telehealth consultations with health care providers.
In their lawsuit, the abortion opponents claimed that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in September, 2000, and that it has since ignored safety risks of the medication.
The F.D.A. and the Justice Department have strongly disputed those arguments and said that the agency’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve the drug.
In his 67-page ruling on Friday evening, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the plaintiffs and repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion” and referring to a fetus as an “unborn human” or “unborn child.”
In seeking a stay of his ruling, lawyers from the Department of Justice, 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. Nor is there any basis in administrative law for the district court’s unprecedented overriding of F.D.A.’s considered scientific judgment.”
The case has attracted interest beyond the groups that usually weigh in on abortion cases. On Monday, more than 400 pharmaceutical industry leaders and investors issued a scathing condemnation of the ruling and demanding that it be reversed.
“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. 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.
Mike Ives contributed reporting.
