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U.S. Supreme Court keeps abortion pill access in place — for now

The Supreme Court said Friday it was temporarily keeping in place federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.

Decision follows Texas district court ordering a hold on federal approval of mifepristone

Several packages of a medication are shown next to cups.
The U.S. Supreme Court said Friday it would take time to more fully consider the issues raised over mifepristone in a court challenge. (Evelyn Hockstein/Reuters)

The U.S. Supreme Court said Friday it was temporarily keeping in place federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.

In an order signed by Justice Samuel Alito, the court asked both sides to weigh in by Tuesday over whether lower court rulings restricting the Food and Drug Administration's approval of the drug, mifepristone, should be allowed to take effect while the case works its way through federal courts. The order suggests the court will decide that issue by late Wednesday.

The justices are being asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by an appellate ruling Wednesday, can be in force while the case continues.

The ruling would have tightened rules by the FDA — the federal agency that oversees drug safety and approvals — around the prescribing and dispensing of mifepristone.

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

The Biden administration and New York-based Danco Laboratories, the maker of the pill, asked the justices to intervene. They warned of "regulatory chaos" and harm to women if the ruling was allowed to move forward.

"The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the Justice Department told the court in a filing.

The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward.

Multiple challenges to abortion drug

The fight over mifepristone lands at the Supreme Court less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright. 

In his April 7 ruling, Kacsmaryk ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision was quickly followed by U.S. District Judge Thomas O. Rice who directed U.S. authorities to not make changes that would limit access to the drug. 

WATCH | Court cases leave mifepristone in limbo: 

Abortion pill in limbo after competing rulings in U.S.

2 years ago
Duration 2:41
Abortion in the U.S. is facing another legal battle after a Texas judge ruled mifepristone, known as the abortion pill, should be taken off the market and a Washington state judge ruled it should stay available.

A late Wednesday ruling by the Fifth Circuit Court of Appeals would have prevented the pill from being mailed or prescribed without an in-person visit to a doctor. It would have also withdrawn the FDA's approval of the drug for use beyond the seventh week of pregnancy. 

In 2016, the FDA extended the time period mifepristone could be used from seven to 10 weeks gestation. At the same time, the FDA removed the requirement for three in-person doctor visits to obtain the drug.

Challenge to FDA oversight

The appeals court did not entirely withdraw FDA approval of mifepristone. The Fifth Circuit narrowed Kacsmaryk's April 7 ruling, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.

"To the government's knowledge, this is the first time any court has abrogated FDA's conditions on a drug's approval based on a disagreement with the agency's judgment about safety — much less done so after those conditions have been in effect for years," wrote Solicitor General Elizabeth Prelogar, the Biden administration's top Supreme Court lawyer, on Friday.

LISTEN | How a legal challenge to mifepristone could impact access to other drugs: 
A U.S. legal fight over the abortion drug mifepristone is prompting concern that the courts could set a precedent around access to other drugs. Matt Galloway talks to Elizabeth Janiak, an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School; and Alice Ollstein, a health care reporter on Capitol Hill for Politico.

Erin Hawley, a lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.

"The Fifth Circuit rightly required the agency to prioritize women's health by restoring critical safeguards, and we'll urge the Supreme Court to keep that accountability in place," said Hawley said, a senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.

Both the Biden administration and Danco want a more lasting order that would protect the current rules and approval for mifepristone while the legal fight continues.

They have also asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to the drug filed by anti-abortion doctors and medical organizations last year.

Mifepristone has been used by millions of people since its approval in 2000. The latest ruling represents a significant challenge to the FDA's oversight of prescription drugs in the U.S.

With files from The Associated Press and Reuters