U.S. Supreme Court's Alito temporarily blocks abortion pill curbs

[April 15, 2023]  By Andrew Chung

WASHINGTON (Reuters) -U.S. Supreme Court Justice Samuel Alito on Friday temporarily halted lower court rulings that set limits on access to the abortion pill mifepristone, giving the nation's top judicial body time to weigh a bid by President Joe Biden's administration to defend the drug amid a challenge by anti-abortion groups.

The action by the conservative justice, who handles emergency matters arising from a group of states including Texas, freezes the litigation and maintains the current availability of mifepristone pending a further order from himself or the entire court.

The U.S. Justice Department and Danco Laboratories, the pill's manufacturer, filed emergency requests earlier on Friday asking the justices to freeze an April 7 preliminary injunction by Texas-based U.S. District Judge Matthew Kacsmaryk that would greatly restrict mifepristone's distribution while litigation contesting its federal regulatory approval proceeds.

Alito acted just hours before the restrictions were due to have taken effect. He directed the challengers to respond by Tuesday to the requests by the Justice Department and Danco, while delaying the restrictions from taking effect until 11:59 p.m. EDT (0359 GMT) on Wednesday. The court would be expected to issue another order on the issue by that time.

The administration is seeking to defend the availability of mifepristone in the face of mounting 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 had legalized the procedure nationwide. Alito authored that ruling for the court, which has a 6-3 conservative majority.

The administration and Danco told the justices in their filings that mifepristone might not be available for months if the restrictions were allowed to take effect.

Mifepristone, approved by the U.S. Food and Drug Administration (FDA) in 2000, is used in combination with another drug called misoprostol to perform medication abortions, which account for more than half of all U.S. abortions. The FDA is the U.S. agency that signs off on the safety of food products, drugs and medical devices.

The Justice Department said the lower court orders issued in the past week limiting mifepristone's availability would have "sweeping consequences" for women who need access to it and the FDA's scientific judgment authority over drug safety.

Danco said it may be forced to halt operations in the face of regulatory uncertainty.

Current drug labels for mifepristone do not account for the new limits and would have to be adjusted, a process that could last months, the Justice Department and Danco said in their filings. The generic version of mifepristone would also lose its approval, the department said.

"The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the department told the justices.

White House spokesperson Karine Jean-Pierre said in a statement the Biden administration would continue to stand by the FDA's decisions and that "the stakes of this fight could not be higher in the face of ongoing attacks on women's health."

A patient prepares to take mifepristone, the first pill given in a medical abortion, at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. REUTERS/Evelyn Hockstein/File Photo

In a case that could undercut the FDA's authority to decide on the safety of drugs, the New Orleans-based 5th U.S. Circuit Court of Appeals on Wednesday declined the administration's request to block Kacsmaryk's restrictions. The 5th Circuit halted another part of Kacsmaryk's order that would have suspended FDA approval of the drug, effectively pulling it off the market.

Kacsmaryk's decision conflicted with an order also issued April 7 in a separate case from Washington state directing the FDA to keep mifepristone available in 17 states and the District of Columbia.

Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to reverse approval of mifepristone.

'FUNDAMENTAL ERRORS'

"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. And the lower courts reached that unprecedented result only through a series of fundamental errors," the Justice Department said in its filing.

The restrictions set by the lower courts would restore curbs on mifepristone that had been lifted since 2016 as the FDA steadily expanded access. These revived restrictions would include requiring three in-person doctor visits to obtain mifepristone and limiting its use to the first seven weeks of pregnancy, down from the current 10.

Some 61% of Americans, including 51% of Republicans, oppose efforts to restrict access to abortion pills, according to a Reuters/Ipsos poll concluded on Wednesday. Just 37% of respondents said they trusted the Supreme Court to act impartially in abortion-related cases.

The Justice Department has said the anti-abortion plaintiffs have no basis for second-guessing FDA scientific judgment and that when used as directed, adverse effects of mifepristone are exceedingly rare "just as they are for many common drugs like ibuprofen." The challengers have called the restrictions critical safeguards to a medication they consider dangerous.

Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy. The latest Republican-led move came in Florida, where Governor Ron DeSantis on Thursday signed a new law that bans most abortions after six weeks of pregnancy.

(Reporting by Andrew Chung in New York; Additional reporting by Trevor Hunnicutt; Editing by Will Dunham)

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