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

(Reuters) – The U.S. Supreme Court on Friday blocked new limits set by lower courts on a widely used abortion drug. The decision was welcomed by President Joe Biden. US Rights.

The judge briefly requested an urgent request by the Justice Department and pill manufacturer Danko Laboratories to stay an April 7 preliminary injunction issued by U.S. District Judge Matthew Kaksmalik of Texas. Acknowledged by order. A judge’s order would have severely limited the availability of mifepristone, but the lawsuit is proceeding with a challenge by anti-abortion groups to the pill’s federal regulatory approval.

In a statement issued by the White House, Biden said, “As a result of the Supreme Court suspension, mifepristone remains available and is approved for safe and effective use while the courts continue this battle. ” he said.

“There are no more risks for women across America, and I will continue to fight politically-led attacks on women’s health,” Biden added.

Conservative judges Clarence Thomas and Samuel Alito publicly opposed the decision. In his brief remarks, Alito wrote that he did not indicate that the regime and Danko could suffer “irreparable damage.”

The Biden administration has banned mifepristone in the face of abortion bans and restrictions enacted by Republican-led states since the Supreme Court overturned the landmark 1973 Roe v. Wade ruling in June 2022. trying to defend. Alito made that ruling.

The current lawsuit has now been returned to the New Orleans-based Court of Appeals for the Fifth Circuit and is scheduled for hearing on May 17.

The Food and Drug Administration (FDA), the US agency that approves food, drug, and medical device safety, approved mifepristone in 2000. dangerous medicine.

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

Eric Baptiste, an attorney at the conservative religious rights group Alliance Defending Freedom, represents opponents of the pill and said, “We are trying to put women’s health before politics. The case is proceeding expeditiously in the lower courts.”

The lawsuit could undermine federal regulators’ authority over drug safety.

“I continue to support the FDA’s evidence-based approval of mifepristone, and my administration will continue to defend the FDA’s independent professional body that reviews, approves, and regulates a wide range of prescription drugs,” Biden said. .

Danko’s attorney, Jessica Ellsworth, said the Supreme Court’s decision “preserves critical access to drugs that millions of patients rely on” after lower courts caused “widespread confusion”. said.

The Fifth Circuit Court of Appeals on April 12 rejected Kacsmaryk’s ordered curb blocking, but the judge suspended FDA approval of mifepristone, effectively pulling it off the market. stopped part of the order of

The Supreme Court took action just hours before its self-imposed deadline of 11:59 pm Friday (0359 GMT EDT Saturday) before Kaksmalik’s mifepristone limit took effect. Alito, which handles emergencies from a range of states, including Texas, last week temporarily stayed Kaksmalik’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, Kaksmalik has a long track record of opposing abortion until the U.S. Senate granted him a tenure as a federal judge in 2019. was

Challenge to FDA

An anti-abortion group led by the recently formed Hippocratic Medical Alliance and four anti-abortion doctors sued the FDA in November.

The FDA has rated mifepristone, which millions of Americans have used for decades, as safe and effective, with very rare side effects.

Abortion rights groups praised Friday’s Supreme Court ruling, but noted that lawsuits are ongoing.

“We are not out of the woods yet,” said Nancy Northup, director of the Reproductive Rights Center.

Had the restrictions been in effect, they would have reversed the recent FDA action to facilitate access to mifepristone. These measures include allowing distribution by mail in 2021, authorizing use up to his 10th week of gestation instead of 7th week in 2016, reducing the dosage required and increasing the number of in-person doctor visits. reduction from 3 times to 1 time.

The Department of Justice and Danko said mifepristone’s current pharmaceutical label would have had to be adjusted to allow for the restoration of restrictions on its use in a process that could take months.

In his dissenting opinion, Alito opposed that possibility, stating, “FDA has elected to exercise its enforcement discretion to suspend Danko, and the applicant’s dossier provides reasons to believe that FDA will make that choice.” Unless you provide it,” he said, it won’t happen.

This restriction also suspends approval of the generic version of the pill manufactured by GenBioPro Inc.

Since last year’s Supreme Court ruling, 12 U.S. states have enacted outright bans, and many others have banned post-pregnancy abortion for a period of time. The latest Republican-led move comes in Florida, where Gov. Ron DeSantis signed into law on his April 13th ban on abortions after six weeks’ gestation.

Reporting by Andrew Chan.Edited by Will Dunham

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