Federal appeals court preserves access to abortion pill but toughens rules

AUSTIN, Texas — A federal appeals court has ruled that the abortion pill mifepristone can still be used for now, but has shortened the period of pregnancy the drug can be taken and said it could not be delivered by mail.

Wednesday night’s decision temporarily reduced a ruling by a Texas trial judge who had completely blocked Food and Drug Administration approval of the nation’s most widely used abortion method. Still, preventing the pill from being mailed amounts to another significant restriction on abortion access, less than a year after the reversal of Roe v. Wade resulted in more than a dozen states outlawing abortion outright.

The case is likely to reach the US Supreme Court.

“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 to reporters from Dublin during a visit by President Joe Biden. . .

The FDA approved mifepristone for use more than two decades ago and it is used in combination with a second drug, misoprostol.

In a far-reaching ruling last week, a federal judge blocked FDA approval of the pill following a lawsuit from opponents of the drug. There is virtually no precedent for a lone judge to overturn the regulator’s medical decisions.

The ruling was put on hold to allow for an appeal.

Just before midnight Wednesday, the US Court of Appeals for the Fifth Circuit in New Orleans ruled that the FDA’s initial approval of mifepristone in 2000 could remain in effect.

But in a 2-1 vote, the panel of judges suspended changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Among them, extending the period of pregnancy in which the drug can be used from seven to 10 weeks, and also allowing it to be dispensed by mail, without the need to visit a doctor’s office.

The two justices who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are appointed by former President Donald Trump. The third judge, Catharina Haynes, is a former President George W. Bush appointee. She said she would have stayed the lower court’s ruling altogether for now to allow for oral arguments in the case.

Either party, or both, could take the case to the Supreme Court. Opponents of the drug could try to uphold the full lower court ruling. In the meantime, the Biden administration could ask the high court to allow all of the FDA’s changes to remain in effect while the case continues.

Adding to the uncertainty, a separate federal judge in Washington last week ordered the FDA not to do anything that could block the availability of mifepristone in 17 Democratic-led states that have sued to keep it on the market. The judge in that case has yet to respond to the Justice Department seeking additional clarity this week.

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

But the judges suggested that the changes the FDA made to make mifepristone more readily available since 2016 had fewer consequences than its initial approval of the drug in 2000. It would be “difficult” to argue that the changes were “as critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years,” the judges wrote.

When the drug was initially approved in 2000, the FDA limited its use to seven weeks of pregnancy. It also required three face-to-face office visits: the first to administer mifepristone, the next to administer the second drug misoprostol, and the third to attend to any complications. It also required supervision by a physician and a reporting system for any serious consequences associated with the drug.

If the appeals court action is upheld, 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 struck down Roe v. Wade last year say they are preparing in case mifepristone is restricted.

New York Gov. Kathy Hochul said Tuesday her state would stockpile 150,000 doses of misoprostol.

The White House also has contingency plans, but Jean-Pierre refrained from detailing them as the legal action continued. Instead, he detailed 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.

This week, pharmaceutical executives also signed a letter condemning the Texas ruling and warning that FDA approval of other drugs could be at risk if U.S. District Judge Matthew Kacsmaryk’s decision stands.

The lawsuit challenging the approval of mifepristone was brought by Alliance Defending Freedom, which was also involved in the Mississippi case that led to the overturning of Roe v. Wade. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency failed to adequately review safety risks.

A spokesperson for Alliance Defending Freedom did not immediately return a message Thursday morning asking what steps it might take next.

Mifepristone has been used by millions of women for the past 23 years, and complications from mifepristone occur at a slower rate than problems with wisdom teeth extraction, colonoscopies and other routine procedures, medical groups recently noted. .


Gresko reported from Washington. Associated Press writers Mark Sherman in Washington and Colleen Long in Dublin contributed to this report.

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