US Supreme Court poised to act on abortion pill curbs

[April 21, 2023]  By Andrew Chung

(Reuters) - The U.S. Supreme Court is poised on Friday to determine whether the abortion pill mifepristone will continue to be broadly available in the United States as it weighs a bid by Democratic President Joe Biden's administration to defend the drug in a challenge to its regulatory approval by anti-abortion groups.

The court faces a self-imposed deadline to act by 11:59 p.m. EDT (0359 GMT on Saturday) before restrictions on access to mifepristone, ordered by conservative U.S. District Judge Matthew Kacsmaryk in Texas on April 7, take effect.

The justices are considering emergency requests by the Justice Department and the pill's manufacturer Danco Laboratories to block the preliminary injunction issued by Kacsmaryk that would greatly limit the availability of mifepristone while the litigation proceeds.

The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. The justices could also fail to act, which would let the restrictions go ahead.

Conservative Justice Samuel Alito on Wednesday extended until the end of Friday an earlier temporary pause he had placed on the dispute to give the court time to consider the matter. Alito handles emergency matters arising from a group of states including Texas.

The administration is seeking to defend 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.

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.

The Food and Drug Administration (FDA), the U.S. agency that signs off on the safety of food products, drugs and medical devices, approved mifepristone in 2000. The current case could undercut federal regulatory authority over drug safety.

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

The New Orleans-based 5th U.S. Circuit Court of Appeals on April 12 declined to block the curbs ordered by Kacsmaryk. The 5th Circuit did halt a part of Kacsmaryk's order that would have suspended the FDA approval of the drug and effectively pull it off the market.

The restrictions, if enacted, would roll back actions taken by the FDA in recent years to make it easier to access mifepristone after confirming the pill's safety and efficacy. Those actions include in 2021 allowing it to be distributed by mail, and in 2016 approving its use up to 10 weeks of pregnancy instead of seven weeks, reducing the dosage required and cutting the number of in-person doctor visits from three to one.

Current drug labels for mifepristone would have to be adjusted to account for the restored limits on its use, a process that the Justice Department and Danco previously said could last months, complicating access to the pill.

The restrictions would also suspend the approval of the pill's generic version made by GenBioPro Inc, which accounts for two-thirds of the mifepristone used in the United States for medication abortions. Nevada-based GenBioPro on Wednesday filed a lawsuit seeking to ensure that it can continue selling its pill amid the ongoing legal challenges.

Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November. The plaintiffs contend that the agency used an unlawful process to approve the drug, which they consider to be dangerous.

(Reporting by Andrew Chung; Editing by Will Dunham)

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