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

Written by Andrew Chung and John Crozel

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

The judges, in a summary order, granted emergency requests from the Department of Justice and grain manufacturer Danco Laboratories to suspend an April 7 preliminary injunction issued by US District Judge Matthew Kaksmarek in Texas. The judge’s order would have greatly limited the availability of mifepristone while litigation continues a challenge by anti-abortion groups to federal regulatory approval of the pill.

“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” Biden said in a statement released by the White House.

“The stakes could not be higher for women across America. I will continue to fight politically motivated attacks on women’s health,” Biden added.

Conservative justices Clarence Thomas and Samuel Alito publicly objected to the decision. Alito wrote, in a curt opinion, that management and Danko did not appear likely to be “irreparably harmed”.

The Biden administration has been seeking to defend mifepristone in the face of escalating abortion bans and restrictions imposed by Republican-led states since the Supreme Court in June 2022 overturned the landmark 1973 Roe v. Wade decision that legalized the procedure nationwide. Alito wrote this ruling.

The current case now goes back to the New Orleans-based 5th US Court of Appeals, which is scheduled to hear arguments on May 17. The losing side after the Fifth Circuit rules can appeal the case back to the Supreme Court.

The Food and Drug Administration (FDA), the US agency that signs off on the safety of food products, drugs, and medical devices, approved mifepristone in 2000. Competitors contend that the FDA illegally approved mifepristone and then removed important safeguards on what they call a dangerous drug .

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

“Our case that seeks to put women’s health above politics is continuing on an urgent basis in the lower courts,” said Eric Baptiste, an attorney with the conservative religious rights group Coalition in Defense of Freedom that represents birth control pill competitors.

The case could undermine federal regulatory authority over drug safety.

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

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

The Fifth Circuit on April 12 refused to block the restrictions ordered by Kacsmaryk but stopped part of the judge’s order that would have suspended the FDA’s approval of mifepristone and effectively withdrawn it from the market.

The Supreme Court acted just hours before its self-imposed deadline of 11:59 p.m. EST Friday (0359 GMT Saturday) before Kacsmaryk’s restrictions on mifepristone went into effect. Alito, who handles emergency matters arising from a group of states including Texas, last week issued a temporary halt to Kajsmarek’s order until Wednesday and then extended it for two more days.

Kaksmarek, a former Christian legal activist appointed to the bench by former President Donald Trump, had a strong track record in opposing abortion before being confirmed by the US Senate in 2019 for a life federal judgeship.

A challenge to the Food and Drug Administration

Anti-abortion groups led by the recently formed Coalition for Hippocratic Medicine and four anti-abortion physicians sued the FDA in November.

Mifepristone has been described by the Food and Drug Administration as safe and effective as proven over decades of use by millions of Americans, with extremely rare adverse effects.

Abortion rights groups applauded the Supreme Court’s decision on Friday but noted that the case was still ongoing.

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

Had the restrictions been in effect, the FDA’s actions in recent years to make access to mifepristone easier would have been overturned. These include in 2021 allowing distribution by mail, in 2016 approving its use for up to 10 weeks of gestation instead of seven weeks, reducing the dose required and reducing the number of in-person doctor visits from three to one.

The Department of Justice and Danco said existing drug labels for mifepristone had to be adjusted to account for restored restrictions on its use in a process that could have taken months.

In his dissent, Alito dismissed that possibility, saying it would not happen “unless the FDA chooses to use its discretion to stop Danco, and the applicants’ papers give no reason to believe that the FDA will make that choice.”

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

Since the Supreme Court’s decision last year, 12 US states have imposed outright bans while many others prohibit abortions after a certain gestational age. The latest Republican-led move came in Florida, where on April 13 Gov. Ron DeSantis signed a law banning most abortions after six weeks of pregnancy.