U.S. Supreme Court upholds broad access to abortion pill By Reuters

by The Insights

© Reuters. Used boxes of Mifepristone, the first pill for medical abortion, line a trash can at the Alamo Women’s Clinic in Carbondale, Illinois, U.S., April 20, 2023. REUTERS/Evelyn Hockstein

By Andrew Chung and John Kruzel

WASHINGTON (Reuters) – The U.S. Supreme Court on Friday blocked new restrictions set by lower courts on a widely used abortion pill, a move hailed by President Joe Biden as his administration defends broad access to the drug in the latest fierce legal battle over reproductive rights in the United States.

The judges, in a brief order, granted emergency requests from the Justice Department and pill maker Danco Laboratories to stay an April 7 preliminary injunction issued by U.S. District Judge Matthew Kacsmaryk in Texas. The judge’s order would have significantly limited the availability of mifepristone while litigation continues in a challenge by anti-abortion groups to the pill’s federal regulatory approval.

“Following the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use as we pursue this fight through the courts,” Biden said in a statement released by the White House.

“The stakes couldn’t be higher for women across America. I will continue to fight political attacks on women’s health,” Biden added.

Conservative judges Clarence Thomas and Samuel Alito publicly opposed the ruling. Alito, in a brief notice, writes that the administration and Danco have failed to demonstrate that they are at risk of “irreparable harm.”

The Biden administration has been seeking to defend mifepristone in the face of growing abortion bans and restrictions enacted by Republican-led states since the Supreme Court in June 2022 overturned the landmark 1973 Roe v. Wade decision that legalized abortion. procedure across the country. Alito is the author of this decision.

The pending case now returns to the United States Court of Appeals for the 5th Circuit, based in New Orleans, which is due to hear arguments on May 17. The losing party after the 5th Circuit rules could appeal the case to the Supreme Court.

The Food and Drug Administration (FDA), the US agency that approves the safety of food, drugs, and medical devices, approved mifepristone in 2000. Challengers argue that the FDA illegally approved mifepristone and then removed critical safeguards on what they call a dangerous drug.

Mifepristone is taken with another drug called misoprostol to perform medical abortion, which accounts for more than half of all abortions in the United States. The drug has other uses, including managing miscarriages.

Erik Baptist, a lawyer for the conservative religious rights group Alliance Defending Freedom representing the pill challengers, said: ‘Our case to put women’s health above politics is fast-tracking through the courts. lower”.

The case could undermine federal regulatory authority over drug safety.

“I continue to defend the FDA’s evidence-based approval for mifepristone, and my administration will continue to defend the independent, expert authority of the FDA to review, approve, and regulate a wide range of prescription drugs,” he said. Biden said.

A Danco lawyer, Jessica Ellsworth, said the Supreme Court’s decision “preserves crucial access to a drug on which millions of patients depend” after lower courts caused “widespread chaos”.

On April 12, the 5th Circuit declined to block restrictions ordered by Kacsmaryk, but halted part of the judge’s order that would have suspended FDA approval of mifepristone and effectively removed it from the market.

The Supreme Court acted just hours before its self-imposed deadline of 11:59 p.m. EDT Friday (0359 GMT Saturday) before Kacsmaryk’s restrictions on mifepristone take effect. Alito, who handles emergency cases from a group of states including Texas, last week issued a temporary stay of Kacsmaryk’s injunction until Wednesday, then extended it for two more days.

A former Christian legal activist appointed to the bench by former President Donald Trump, Kacsmaryk had a long track record of opposing abortion before the US Senate confirmed him in 2019 to serve as a federal judge for life.

A CHALLENGE TO THE FDA

Anti-abortion groups led by the newly formed Hippocratic Medicine Alliance and four anti-abortion doctors sued the FDA in November.

The FDA has rated mifepristone as safe and effective, as demonstrated by decades of use by millions of Americans, with extremely rare side effects.

Abortion rights groups welcomed the Supreme Court’s decision on Friday, but noted that the case is ongoing.

“We’re not out of the woods yet,” said Nancy Northup, president of the Center for Reproductive Rights.

The restrictions, if they had taken effect, would have reversed the actions of the FDA in recent years to facilitate access to mifepristone. These actions include in 2021 the authorization of distribution by mail and in 2016 the approval of its use up to 10 weeks of pregnancy instead of seven weeks, the reduction of the required dosage and the reduction of the number of medical visits in three to one person.

Current drug labels for mifepristone should have been adjusted to accommodate restored limits on its use in what could have been a months-long process, the Justice Department and Danco had said.

In his dissent, Alito dismissed that possibility, saying it wouldn’t happen “unless the FDA chooses to use its enforcement discretion to shut down Danco, and plaintiffs’ documents provide no reason to believe.” that the FDA would make that choice.”

The restrictions would also have suspended approval of the generic version of the pill made by GenBioPro Inc.

Since last year’s Supreme Court ruling, 12 US states have implemented outright bans while many others ban abortion after a certain length of pregnancy. The latest Republican-led decision came in Florida, where Governor Ron DeSantis signed a law on April 13 banning most abortions after six weeks of pregnancy.

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