What’s next, after abortion pill ruling

Second federal case, now proceeding, to also affect outcome.

The WASHINGTON — Supreme Court issued a decision Friday night that maintained the Food and Drug Administration’s approval of a commonly used abortion pill while an appeal moves forward, the latest development in a fast-moving legal battle that followed a lower court’s ruling that ordered the drug pulled off the market. Justice Samuel Alito had paused the lower court’s ruling on the pill, mifepristone, but that freeze had been set to expire at midnight. The justices issued their decision about five hours before the deadline. When the justices overturned Roe v. Wade in June, the conservative majority said the legislative branch, not the courts, should make decisions on abortion policy. But the issue quickly made its way back to the Supreme Court, in a case that may have wide-ranging consequences even in states where abortion is legal, as well as for the FDA’s regulatory authority over other drugs.

What’s at stake?

At issue is the availability of mifepristone, the first pill taken in a twodrug regimen that now accounts for more than half of the abortions in the United States. More than 5 million women have used mifepristone to terminate their pregnancies in the United States, and dozens of other countries have approved the drug for use. Federal judges have questioned steps the FDA has taken to expand the drug’s distribution, and the 5th U.S. Circuit Court of Appeals, in New Orleans, imposed significant barriers to access last week, even as it said it would allow the pill to remain on the market. That decision essentially turned back the clock seven years, before the FDA added a series of guidelines in 2016 that eased access to the pill. The restrictions would require 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. Those rules would have effectively prevented patients from receiving mifepristone by mail, which has made obtaining the medication easier for many patients. Before the changes in 2016, mifepristone was only authorized for use until seven weeks into pregnancy; now the time frame is 10 weeks into pregnancy, allowing medication abortion for many more patients. And the appeals court ruling appeared to have declared invalid the FDA’s approval in 2019 of a generic version of mifepristone, manufactured by GenBioPro, whose product now accounts for two-thirds of the mifepristone used in the United States. The restrictions in the appeals court’s preliminary ruling are all on pause for now, but the case will continue, with oral arguments before the appeals court scheduled for May 17. The case could also pave the way for all sorts of challenges to the FDA’s approval of medications. Legal experts said medical providers anywhere in the country might be enabled to challenge government policy that might affect a patient, as did the anti-abortion medical coalition that filed the original lawsuit against the pill. And leaders of the pharmaceutical and biotech industries have filed briefs saying that the case could undermine their businesses by destroying their ability to rely on a single national standard for their products.

How did we get here?

The dispute traces to a lawsuit by an umbrella group of medical organizations and four doctors who oppose abortion, challenging the FDA’s approval of mifepristone 23 years ago. The suit, filed in the Amarillo division of the U.S. District Court for the Northern District of Texas, came before a single federal judge: Matthew Kacsmaryk, a Trump appointee who is known as a longtime opponent of abortion. The plaintiffs have claimed the pill is unsafe and the agency’s approval process for the drug was flawed. The FDA has forcefully countered those claims, contending the drug is very safe and effective. It has cited a series of studies that show that serious complications are unusual and less than 1% of patients need hospitalization. In his preliminary ruling, Kacsmaryk said the Food and Drug Administration had improperly approved the drug, essentially ordering it off the market. He gave the agency a week to seek emergency relief before his ruling would take effect. The Biden administration immediately appealed, and a divided three-judge panel of the 5th U.S. Circuit Court of Appeals said mifepristone could remain available as the lawsuit makes its way through the courts, but it said the 2016 restrictions should take effect immediately. The Biden administration then appealed to the Supreme Court, which issued Friday evening’s order that the status quo should remain in effect until the full case is resolved.

What about the case in Washington state?

A second case about the abortion pill is proceeding in a federal courtroom in Washington state, after Democratic attorneys general of 17 states and the District of Columbia filed a lawsuit challenging the renewed FDA restrictions on access to mifepristone. Less than an hour after Kacsmaryk issued his ruling, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, blocked the agency from doing anything to curb the availability of mifepristone in those 17 states and the District of Columbia. Although his order did not affect the entire country, the states in that lawsuit represent a majority of states where abortion remains legal. And drug policy experts said the order essentially had national implications because it would be logistically untenable for the FDA to apply one set of rules about a drug to some states and not others. Legal experts said the direct conflict between the Washington state case and the 5th Circuit’s decision to block specific parts of the FDA’s rules for the abortion drug helped ensure the Supreme Court would have to weigh in. As the dueling cases work their way through the courts now, their outcomes will affect the ultimate resolution of the abortion pill conflict. As will the outcome of a new lawsuit filed Wednesday in federal court in Maryland, in which the maker of the generic version of mifepristone is asking a court to order the FDA not to immediately pull generic mifepristone from the market if another court ordered the agency to do so.

JACKIE MOLLOY/THE NEW YORK TIMES Mifepristone is part of a two-drug regimen that now accounts for more than half of abortions in the U.S. While federal judges questioned how the FDA expanded distribution of the regimen, and have imposed barriers to access, a U.S. district judge ruled to stop courts from blocking the distribution in some states.