WASHINGTON — The future of a widely used abortion pill is at the center of a legal battle before the Supreme Court, which for the second time in a year is about to consider a major effort to severely restrict access to abortion.
The court is expected to decide Friday night whether to grant the Biden administration’s emergency request to uphold the Food and Drug Administration’s approval of the pill, mifepristone, after a lower court limited the drug’s availability while an appeal is pending .
Justice Samuel A. Alito Jr. had paused the lower court ruling, but that freeze expires at midnight. That means the judges will likely decide before then, though they could extend the deadline or do nothing.
When justices overturned Roe v. Wade in June, the conservative majority said the political branch, not the courts, should make decisions about abortion policy. But the issue has quickly made its way to the Supreme Court, in a case that could have far-reaching implications even in states where abortion is legal, as well as for the FDA’s regulatory authority over other drugs.
Here’s what could happen next.
What’s at stake?
At issue is the availability of mifepristone, part of a two-drug regimen now responsible for more than half of abortions in the United States. More than five million women have used mifepristone to terminate their pregnancy 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 distribution of the drug, and the U.S. Court of Appeals for the Fifth Circuit, in New Orleans, last week imposed significant barriers to entry, even though it said it would allow the pill to stay on the market.
The decision essentially turns back the clock to 2016, when the FDA added a series of guidelines that eased access to the pill. The restrictions include blocking patients from receiving the drug in the mail.
Experts say removing the postal option would have significant ramifications: Patients would have to take time off from work, pay travel expenses to get to a medical office, and endure the stigma of going out in public to have a medical appointment. to seek an abortion.
The case could also pave the way for all sorts of challenges to FDA drug approval. Legal experts said medical providers anywhere in the country could be empowered to challenge government policies that could affect a patient, much like the anti-abortion medical coalition that brought the original lawsuit against the pill.
What happens now?
When the Biden administration asked the Supreme Court to intervene, the application was granted to Judge Alito, who oversees the Fifth Circuit. Justice Alito issued an order last Friday to ensure that the pill would remain available everywhere. The order was extended for another two days on Wednesday.
That the court said on Wednesday it would give itself more time to consider the pill’s availability suggests there may be disagreement among the judges.
The judges will likely decide whether to grant the administration’s request and have several options: ensure full access to mifepristone; impose significant restrictions, but do not sharply limit the availability of the drug; or take the pill off the market entirely, as a Texas federal judge did in the original case.
Whatever the judges do in the meantime, the trial will continue, probably in the appellate court. But the Supreme Court may take the unusual step of skipping the appeals court and hearing the case itself right away.
If the Supreme Court decides not to grant the Biden administration’s request, the Fifth Circuit’s decision will stand.
How did we get here?
The dispute traces back to a lawsuit by an umbrella group of medical organizations and a few anti-abortion doctors challenging the FDA’s approval of the pill more than two decades ago.
The lawsuit, filed in the Amarillo Division of the U.S. District Court for the Northern District of Texas, came before a single federal judge: Matthew J. Kacsmaryk, a Trump appointee known as a longtime opponent of abortion.
Prosecutors have alleged that the pill is unsafe and that the agency’s approval process for the drug was flawed. The FDA has vigorously refuted these claims, claiming that the drug is very safe and effective. It cited a series of studies showing that serious complications are uncommon and fewer than 1 percent of patients require hospitalization.
In his preliminary ruling, Judge Kacsmaryk said the Food and Drug Administration improperly approved the drug. But he gave the agency a week to seek emergency assistance before his ruling took effect.
The Biden administration immediately appealed, and a divided three-judge panel of the U.S. Court of Appeals for the Fifth Circuit said mifepristone could remain available while the lawsuit moves through the courts.
But in addition to banning the pills from being mailed, the panel blocked non-medical health care providers from prescribing them.
What about the case in Washington State?
A second abortion pill case is underway in a federal courtroom in Washington state after the Democratic attorneys general of 17 states and the District of Columbia filed suit against renewed FDA restrictions on access to mifepristone.
Less than an hour after Judge Kacsmaryk delivered his ruling, U.S. District Court Judge Thomas O. Rice for the Eastern District of Washington, an Obama appointee, blocked the agency from reviewing the availability of mifepristone in those 17 states and the District of Columbia. curb. . While his order didn’t affect the entire country, the states in that lawsuit represent a majority of states where abortion remains legal.
Legal experts say the direct conflict between the Washington state case and the Fifth Circuit’s decision to block specific parts of the FDA’s rules on the abortion drug raises the likelihood that the Supreme Court will quickly address the merits of the dispute .
Adam Liptak reporting contributed.
