Emergency request buys time for lawsuit over FDA approval of mifepristone to continue

Mark Sherman Associated Press
Staff with the group, Progressive Anti-Abortion Uprising, Kristin Turner, of San Francisco, left, Lauren Handy, of Washington, and Caroline Smith, of Washington, right, demonstrate against abortion pills outside of the Supreme Court, Friday, April 21, 2023, ahead of an abortion pill decision by the court in Washington. (AP Photo/Jacquelyn Martin)
Staff with the group, Progressive Anti-Abortion Uprising, Kristin Turner, of San Francisco, left, Lauren Handy, of Washington, and Caroline Smith, of Washington, right, demonstrate against abortion pills outside of the Supreme Court, Friday, April 21, 2023, ahead of an abortion pill decision by the court in Washington. (AP Photo/Jacquelyn Martin)AP Jacquelyn Martin
The Supreme Court is seen on Friday, April 21, 2023, in Washington after the court decided to preserve women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Alex Brandon)
The Supreme Court is seen on Friday, April 21, 2023, in Washington after the court decided to preserve women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Alex Brandon)AP Alex Brandon
FILE - The Supreme Court is seen, with a carving of Justice in the foreground, April 19, 2023, in Washington. The Supreme Court is facing a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. (AP Photo/Jacquelyn Martin, File)
FILE - The Supreme Court is seen, with a carving of Justice in the foreground, April 19, 2023, in Washington. The Supreme Court is facing a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. (AP Photo/Jacquelyn Martin, File)AP Jacquelyn Martin
Activist Nadine Seiler of Waldorf, Md., demonstrates in front of the Supreme Court on Capitol Hill in Washington, Thursday, April 20, 2023, as she laments the absence of people to protest the conservative majority on the high court. Justices are leaving women's access to an abortion pill untouched until at least Friday, while they consider whether to allow restrictions on mifepristone to take effect. (AP Photo/J. Scott Applewhite)
Activist Nadine Seiler of Waldorf, Md., demonstrates in front of the Supreme Court on Capitol Hill in Washington, Thursday, April 20, 2023, as she laments the absence of people to protest the conservative majority on the high court. Justices are leaving women's access to an abortion pill untouched until at least Friday, while they consider whether to allow restrictions on mifepristone to take effect. (AP Photo/J. Scott Applewhite)AP J. Scott Applewhite
FILE - Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022. The Supreme Court is facing a self-imposed Friday, April 21, 2023, night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. (AP Photo/Allen G. Breed, File)
FILE - Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022. The Supreme Court is facing a self-imposed Friday, April 21, 2023, night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. (AP Photo/Allen G. Breed, File)AP Allen G. Breed
The Supreme Court is seen, Friday, April 21, 2023, ahead of an abortion pill decision in Washington. (AP Photo/Jacquelyn Martin)
The Supreme Court is seen, Friday, April 21, 2023, ahead of an abortion pill decision in Washington. (AP Photo/Jacquelyn Martin)AP Jacquelyn Martin
The Supreme Court is seen on Friday, April 21, 2023, in Washington. The Supreme Court has preserved women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Jacquelyn Martin)
The Supreme Court is seen on Friday, April 21, 2023, in Washington. The Supreme Court has preserved women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Jacquelyn Martin)AP Jacquelyn Martin
Activist Nadine Seiler of Waldorf, Md., demonstrates in front of the Supreme Court on Capitol Hill in Washington, Thursday, April 20, 2023, as she laments the absence of people to protest the conservative majority on the high court. Justices are leaving women's access to an abortion pill untouched until at least Friday, while they consider whether to allow restrictions on mifepristone to take effect. (AP Photo/J. Scott Applewhite)
Activist Nadine Seiler of Waldorf, Md., demonstrates in front of the Supreme Court on Capitol Hill in Washington, Thursday, April 20, 2023, as she laments the absence of people to protest the conservative majority on the high court. Justices are leaving women's access to an abortion pill untouched until at least Friday, while they consider whether to allow restrictions on mifepristone to take effect. (AP Photo/J. Scott Applewhite)AP J. Scott Applewhite
The Supreme Court is seen on Friday, April 21, 2023, in Washington. The Supreme Court has preserved women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Jacquelyn Martin)
The Supreme Court is seen on Friday, April 21, 2023, in Washington. The Supreme Court has preserved women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Jacquelyn Martin)AP Jacquelyn Martin
The Supreme Court is seen on Friday, April 21, 2023, in Washington after the court decided to preserve women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Alex Brandon)
The Supreme Court is seen on Friday, April 21, 2023, in Washington after the court decided to preserve women's access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues. The justices on Friday granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. (AP Photo/Alex Brandon)AP Alex Brandon
FILE - A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kan., on Wednesday, Oct. 12, 2022. The Supreme Court is facing a self-imposed Friday, April 21, 2023, night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. The justices are weighing arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of the drug, mifepristone, which is used in the most common abortion method in the United States. (AP Photo/Charlie Riedel, File)
FILE - A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kan., on Wednesday, Oct. 12, 2022. The Supreme Court is facing a self-imposed Friday, April 21, 2023, night deadline to decide whether women’s access to a widely used abortion pill will stay unchanged until a legal challenge to its Food and Drug Administration approval is resolved. The justices are weighing arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of the drug, mifepristone, which is used in the most common abortion method in the United States. (AP Photo/Charlie Riedel, File)AP Charlie Riedel

WASHINGTON, D.C. — The Supreme Court on Friday preserved women’s access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues.

The justices granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. They are appealing a lower court ruling that would roll back Food and Drug Administration approval of mifepristone.

The drug has been approved for use in the U.S. since 2000 and more than 5 million people have used it. Mifepristone is used in combination with a second drug, misoprostol, in more than half of all abortions in the U.S.

The court’s action Friday almost certainly will leave access to mifepristone unchanged at least into next year, as appeals play out, including a potential appeal to the high court. The next stop for the case is at the New Orleans-based U.S. Court of Appeals for the 5th Circuit, which has set arguments in the case for May 17.

Two of the nine justices — Samuel Alito, the author of last year’s decision overturning Roe v. Wade, and Clarence Thomas — voted to allow restrictions to take effect, and Alito issued a four-page dissent. No other justices commented on the court’s one-paragraph order, and the court did not release a full vote breakdown.

President Joe Biden praised the high court for keeping mifepristone available while the court fight continues.

“The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women’s health. But let’s be clear — the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v. Wade,” Biden said in a statement.

Alliance Defending Freedom, representing abortion opponents challenging the FDA’s approval of mifepristone, downplayed the court’s action.

“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” ADF lawyer Erik Baptist said in a statement.

The justices weighed arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of mifepristone.

The Supreme Court had initially said it would decide by Wednesday whether the restrictions could take effect while the case continues. A one-sentence order signed by Alito on Wednesday gave the justices two additional days, without explanation.

The challenge to mifepristone is the first abortion controversy to reach the nation’s highest court since its conservative majority overturned Roe v. Wade 10 months ago and allowed more than a dozen states to effectively ban abortion outright.

In his majority opinion last June, Alito said one reason for overturning Roe was to remove federal courts from the abortion fight. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives,” he wrote.

But even with their court victory, abortion opponents returned to federal court with a new target: medication abortions, which make up more than half of all abortions in the United States.

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Women seeking to end their pregnancies in the first 10 weeks without more invasive surgical abortion can take mifepristone, along with misoprostol. The FDA has eased the terms of mifepristone’s use over the years, including allowing it to be sent through the mail in states that allow access.

The abortion opponents filed suit in Texas in November, asserting that the FDA’s original approval of mifepristone 23 years ago and subsequent changes were flawed.

They won a ruling on April 7 by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, revoking FDA approval of mifepristone. The judge gave the Biden administration and Danco Laboratories a week to appeal and seek to keep his ruling on hold.

Responding to a quick appeal, two more Trump appointees on the 5th U.S. Circuit Court of Appeals said the FDA’s original approval would stand for now. But Judges Andrew Oldham and Kurt Engelhardt said most of the rest of Kacsmaryk’s ruling could take effect while the case winds through federal courts.

Their ruling would have effectively nullified changes made by the FDA starting in 2016, including extending from seven to 10 weeks of pregnancy when mifepristone can be safely used. The court also would have halted sending the drug in the mail or dispensing it as a generic, and patients who seek it would have had to make three in-person visits with a doctor. Women also might have been required to take a higher dosage of the drug than the FDA says is necessary.

The administration and Danco have said that chaos would ensue if those restrictions were to take effect while the case proceeds. Potentially adding to the confusion, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit.

The Biden administration has said the rulings conflict and create an untenable situation for the FDA.

Alito questioned the argument that chaos would result, saying the administration “has not dispelled doubts that it would even obey an unfavorable order in these cases.”

And a new legal wrinkle threatened even more complications. GenBioPro, which makes the generic version of mifepristone, filed a lawsuit Wednesday to preemptively block the FDA from removing its drug from the market, in the event that the Supreme Court doesn’t intervene.

The Supreme Court was only being asked to block the lower-court rulings through the end of the legal case.

The appeals court has sped up its review, but there is no timetable for a ruling.

Any appeal to the Supreme Court would follow within three months of a ruling, but with no deadline for the justices to decide whether to review the case.

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Associated Press writers Jessica Gresko, Geoff Mulvihill and Matthew Perrone contributed to this report. Mulvihill reported from Cherry Hill, New Jersey.

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