DOJ to ask Supreme Court to put abortion pill limits on hold

By PAUL J. WEBER and JESSICA GRESKO
Associated Press

AUSTIN, Texas (AP) — The Justice Department said Thursday that it will again go to the Supreme Court over abortion after a lower court ruling allowed the abortion pill mifepristone to remain available in the U.S. but reimposed past restrictions on getting and using the drug.

At stake in the accelerating court battle that began in Texas is widespread access to the most common method of abortion in the U.S., less than a year after the reversal of Roe v. Wade prompted more than a dozen states to effectively ban abortion outright.

In a ruling late Wednesday, the 5th U.S. Circuit Court of Appeals in New Orleans temporarily narrowed a ruling by a lower court judge in Texas that had completely blocked the Food and Drug Administration’s approval of mifepristone. But a divided three-judge panel still reduced the period of pregnancy when the drug can be taken and said it could not be dispensed by mail.

The ruling preventing the pill from being sent by mail amounts to another significant constraint of abortion access that could be felt even in states where abortion remains legal, some of which have already begun stockpiling mifepristone over worries that the drug will become unavailable.

The Justice Department said it would ask the U.S. Supreme Court for an emergency order to stop the lower court ruling from taking effect.

“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre said Thursday, speaking from Dublin during a visit by President Joe Biden.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Abortion rights groups expressed both relief over FDA approval remaining in place and outrage over the appeals court reinstating restrictions. Whole Woman’s Health, an abortion provider that operates six clinics in five states, said in a tweet it was continuing to offer mifepristone in clinics and through virtual services while reviewing the decision.

In the 2-1 decision, the judges put on hold changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those included extending the period of pregnancy when the drug can be used from seven weeks to 10 and allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The panel’s decision came just days after the Justice Department appealed last week’s far-reaching ruling out of Texas that blocked the FDA’s approval of the pill. The lawsuit was filed by the Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade, and is representing a group of anti-abortion doctors.

There is virtually no precedent for a lone judge overturning the regulator’s medical decisions.

Attorneys for the plaintiffs indicated Thursday that they were content with the court’s order and did not plan to seek an appeal that might restore the Texas court’s full ruling.

“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” said Erin Hawley, an attorney for Alliance Defending Freedom.

The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for now to allow oral arguments in the case.

Adding to the uncertainty, a separate federal judge in Washington state last week ordered the FDA not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market. The judge in that case clarified Thursday that his order requires the FDA to keep access the same as it was in January in those states, leaving the agency facing conflicting court orders.

“This is just as much of a binding court order as whatever comes out of Texas,” said David S. Cohen, a law professor at Drexel University’s Thomas R. Kline School of Law.

The New Orleans appeals court judges in the majority in Wednesday’s decision noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling.

But the judges suggested FDA changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for 16 years” the judges wrote.

When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug.

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.

Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing in case mifepristone becomes restricted. New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol.

The White House also has contingency plans in place, but Jean-Pierre held off detailing them while legal action continued. Instead, she described a proposed new federal rule to limit how law enforcement and state officials collect medical records if they investigate women who flee their home states to seek abortions elsewhere.

At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The panel overturned multiple decisions made by FDA regulators after years of scientific review.

Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires surgery to stop.

Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”

More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women who took the drug.

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Gresko reported from Washington. Associated Press writers Mark Sherman and Lindsay Whitehurst in Washington, Colleen Long in Dublin and Matt Perrone in Atlanta contributed to this report.