A conservative federal judge in Texas has issued an order intended to halt the federal approval of mifepristone, a widely used abortion pill that has been on the market in the U.S. for nearly a quarter-century.
The immediate effects of the order, issued Friday, were unclear. The Texas judge gave the federal government a week-long window to appeal, and a federal judge in Washington State almost simultaneously issued a conflicting order.
But the judicial drama raised the prospect that mifepristone could be pulled from the market nationwide.
Mifepristone is one drug in the two-part sequence typically used in pill-induced abortions. About one in two abortions in the U.S. are carried out with medication.
The case has returned Texas to the center of America’s abortion debate. A strict abortion ban took effect in the state months before the Supreme Court overturned Roe v. Wade last year.
This time, the order in Texas could influence abortion access as far away as New York, which has long had some of America’s most robust reproductive protections.
Last year, New York City moved to guarantee free medication abortion access for anyone who needs it.
Here is what New Yorkers should know about the mifepristone case.
What is mifepristone?
Mifepristone is an abortion pill that was approved by the Food and Drug Administration in 2000. It is typically used with a second drug, misoprostol, to end a pregnancy within the first 10 weeks.
Under FDA rules, mifepristone can only be prescribed by certified health care providers. The hormone-blocker has been used by more than 5 million people in the U.S. since its approval.
Challengers in the Texas case say the drug’s safety was never fully vetted. Medical groups say the pill has a strong safety record.
In New York, the City Council passed a law last year requiring city-run health clinics to offer free sequences of mifepristone and misoprostol.
Will New Yorkers lose access to mifepristone?
The ruling in Amarillo Federal Court by Judge Matthew Kacsmaryk, an appointee of former President Donald Trump known to harbor strong anti-abortion views, could push the pill off the market across the nation.
But the order marks a remarkable challenge to the FDA’s authority, and generated a swift legal challenge from the federal government on Friday.
“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” President Biden said in a statement.
Before Kacsmaryk’s order, Donna Lieberman, executive director of the New York Civil Liberties Union, described the case as “outlandish and unprecedented.”
“It’s simply about extending the long arm of those who would ban abortion into places like New York,” she said.
Do New Yorkers have other medication abortion options?
Yes. Misoprostol, the second drug typically used with mifepristone, could still be used. It is used on its own in other countries where mifepristone is not available. But misoprostol is not as effective when used without mifepristone.
What are New York leaders saying?
Gov. Hochul, a Democrat, said Saturday that there is “no rational basis” for the Texas ruling “other than oppression.”
“What has happened is we’re now politicizing medicine,” the governor told reporters at the Executive Mansion in Albany. “This is very, very disturbing.”
The governor promised to put a bill before the Legislature next week to protect New Yorkers’ access to abortion medication. Her powers would appear limited if mifepristone is taken off the market, but she could move to widen access to misoprostol.
“I want to make sure all New Yorkers know that we’re going to continue protecting their rights here in New York,” Hochul said. “This is the place where we had access to legal abortion three years before the rest of the nation. This is part of our legacy.”
In a statement on Friday, Mayor Adams described the Texas order as a “clear act of war on women,” and a “cruel and inhumane decision by a court set on trampling the law, not upholding it.”
Adams, a Democrat, said more than 2,000 women had medication abortions in city medical facilities last year.
The mayor pledged in his statement that his administration would “fight every day to stop efforts to control women’s bodies.”
Does the Texas judge have the authority to revoke the FDA approval?
Kacsmaryk has acknowledged the doubt some harbor about his authority to suspend mifepristone’s approval.
At a hearing last month, Kacsmaryk asked Erik Baptist, a lawyer for the anti-abortion group in the case, what power his court has to suspend the FDA’s regulatory approval of mifepristone.
“Explain to me your argument on why this court has that sweeping authority?” Kacsmaryk asked Baptist, who cited alleged harms faced by doctors and patients.
Kacsmaryk, sufficiently swayed, issued a 67-page opinion on Friday saying that the FDA’s actions in the approval process had been “arbitrary and capricious,” and ordering a stay of the drug’s approval.
“The court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
Also Friday, the federal government appealed to the U.S. Court of Appeals for the Fifth Circuit, a conservative court based in New Orleans.
Attorney General Merrick Garland said in a statement that the Justice Department “strongly disagrees” with Kacsmaryk’s decision.
In his order, Kacsmaryk allowed a seven-day window before his opinion takes effect “to allow the federal government time to seek emergency relief” at the appeals court.
What happens next in the case?
If the appeals court declines a request for a stay of Kacsmaryk’s order, the case could quickly wind up at the Supreme Court.
Among the factors pointing toward a swift Supreme Court review is the potential for legal confusion following the ruling in Washington State.
In a blue-state challenge, Washington and 17 other states sued the FDA in February, asking a federal judge to affirm the “conclusion that mifepristone is safe and effective.”
The lawsuit against the FDA centers on January modifications that the FDA made to mifepristone’s dispensing guidelines. But the complaint, filed three months after the Texas suit, was intended to head off a red-state ruling against the pill.
In Washington on Friday, Judge Thomas Rice, an appointee of former President Barack Obama, issued an order in the case that flatly contradicted the ruling made 1,500 miles away in Texas.
Rice’s order in the U.S. District Court for the Eastern District of Washington temporarily enjoins the FDA from “altering the status quo” regarding the availability of mifepristone.
The Supreme Court, remade by Trump, has a 6-to-3 conservative majority that in Dobbs v. Jackson Women’s Health Organization erased the constitutional right to abortion last summer. But it is unclear how the Supreme Court would handle the pill case.
Carl Tobias, a law professor at the University of Richmond, said Saturday that the Supreme Court could soon have a high-stakes decision on whether to temporarily uphold the order out of Texas or the decision out of Wasington.
“It’s hard to predict what’s going to happen,” Tobias said. “It’s a huge mess.”