WASHINGTON – The Supreme Court issued a ruling Friday night that maintains the Food and Drug Administration’s approval of a commonly used abortion pill pending an appeal, after a lower court limited the drug’s availability.
Justice Samuel A. Alito Jr. stopped. the lower court’s ruling on the pill, mifepristone, but the freeze is set to expire at midnight. The magistrates 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 returned to the Supreme Court, in a case that had far-reaching consequences even for states where abortion is legal, as well as for the FDA’s regulatory authority over other drugs.
Here’s what happens next.
What is at stake?
At issue is the availability of mifepristone, part of a two-drug regimen that now accounts for more than half of abortions in the United States. More than five million women have used mifepristone to end their pregnancies in the United States, and many countries have approved the drug for use.
Federal judges have questioned the steps taken by the FDA to expand distribution of the drug, and the US Court of Appeals for the Fifth Circuit, in New Orleans, has imposed significant obstacles to access last week, although said to allow the tablet to remain. in the market.
That decision essentially turned the clock back to 2016, before the FDA added a series of guidelines that eased access to the pill. Restrictions may include preventing patients from receiving medication by mail.
Experts say removing the mail option has many consequences: Patients will have to take time off work, pay travel costs to get to a doctor’s office and endure the stigma of going out in public to seek an abortion.
The case could also pave the way for all kinds of challenges to the FDA’s approval of drugs. Legal experts say that medical providers anywhere in the country may be able to challenge government policy that affects a patient, such as the anti-abortion medical coalition that filed the original lawsuit against the pill. .
How did we get here?
The dispute traces back to a lawsuit by an umbrella group of medical organizations and some anti-abortion doctors, challenging the FDA’s approval of the pill more than two decades ago.
The case, filed in the Amarillo division of the US District Court for the Northern District of Texas, came before a federal judge: Matthew J. Kacsmaryk, a Trump appointee who is known as a longtime opponent of abortion.
The plaintiffs claim the pill is unsafe and the agency’s approval process for the drug was flawed. The FDA strongly opposed those claims, arguing that the drug was safe and effective. It cited a series of studies showing that serious complications are uncommon and that less than 1 percent of patients require hospitalization.
In his preliminary ruling, Judge Kacsmaryk, the federal judge in Texas, said the Food and Drug Administration improperly approved the drug. But he gave the agency a week to seek emergency relief before his ruling took effect.
The Biden administration immediately appealed, and a divided three-judge panel of the US Court of Appeals for the Fifth Circuit said mifepristone could remain available while the case continued in the courts.
But in addition to banning the mailing of the pills, the panel blocked health care providers who are not doctors from prescribing them.
What about the case in Washington State?
A second lawsuit over the abortion pill continues in a federal court in Washington State, after Democratic attorneys general in 17 states and the District of Columbia filed a lawsuit challenging the revised FDA restrictions on access to mifepristone.
Less than an hour after Judge Kacsmaryk issued his ruling, Judge Thomas O. Rice of the US District Court for the Eastern District of Washington, an Obama appointee, blocked the agency from restricting 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 the majority of states where abortion remains legal.
Adam Liptak contributed to the report.
