Supreme Court poised to rule on abortion pill restrictions

WASHINGTON — The Supreme Court is expected to act Wednesday on a request by the federal government to immediately block a lower court ruling that would imperil access to abortion pill mifepristone.

The Food and Drug Administration and Danco Laboratories, which makes the brand version of mifepristone, Mifeprex, are both seeking to put on hold a ruling last week by the 5th U.S. Circuit Court of Appeals that would suspend several regulatory decisions since 2016 that made it easier to obtain the drug.

The Supreme Court, which has a 6-3 conservative majority, temporarily blocked the appeals court ruling on Friday while the justices consider what next steps to take. The court is set to act by midnight Wednesday.

To win, the Biden administration would need the votes of at least five of the nine justices on the court, which ruled 5-4 last summer to overturn the landmark Roe v. Wade ruling, which said women nationwide have the right to obtain abortions.

The new case raises different legal issues about the FDA’s process for approving drugs, but it will nevertheless test the court’s pledge last year that it would leave abortion policy to the states and the federal government.

The appeals court had somewhat narrowed the scope of an even broader ruling issued April 7 by Texas-based U.S. District Judge Matthew Kacsmaryk. The 5th Circuit declined to suspend the original FDA approval of mifepristone in 2000, as Kacsmaryk had ruled, which would have made distributing it unlawful.

But the appeals court allowed separate elements of Kacsmaryk’s decision to remain in place. If those parts go into effect, the FDA’s decision in 2021 to allow mifepristone to be distributed by mail would be suspended, as would the 2019 decision that approved a generic version of mifepristone, made by GenBioPro.

The FDA’s 2016 changes also reduced the number of in-person visits patients are required to make from three to one and allowed the pills to be prescribed to women at up to 10 weeks’ gestation instead of up to seven weeks.

The appeals court concluded that the anti-abortion coalition bringing the lawsuit had waited too long to contest the 2000 approval in court. But the court found the claims against the 2016 revisions and later decisions could be pursued. It also found that a hitherto obscure 19th century law called the Comstock Act, which prohibits the mailing of any drug or medicine that can be used for abortion, factors into its analysis of the 2021 decision to allow mifepristone to be distributed by mail.

A federal judge in Washington state added a further wrinkle by issuing a preliminary injunction in a different case barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”

That ruling, also issued April 7, applies only to 17 liberal-leaning states and Washington, D.C., which sued in February challenging the FDA’s regulations over the drug.

Both rulings in the Texas litigation have attracted strong criticism from various quarters, including the pharmaceutical industry. In a brief filed at the Supreme Court, the trade group PhRMA said that if the logic of Kacsmaryk’s ruling was applied to other drugs it would upend the “settled regulatory framework and the investments that hinge upon it.” 

Kacsmaryk’s ruling was the first since the FDA was created almost a century ago in which “any court had nullified an FDA approval by second-guessing a safety-and-effectiveness determination,” the brief said.

While a different drug, misoprostol, can be used alone for abortions, experts have said it is not as effective in terminating pregnancies as it is when administered in tandem with mifepristone.

A majority of abortions in the U.S. are carried out with the use of pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.

As a result of the Supreme Court’s decision to overturn Roe v. Wade, various conservative states have enacted tough abortion restrictions that already make it difficult if not impossible for women to terminate a pregnancy, whether by accessing pills or undergoing a surgical procedure. There are 12 states where abortion is effectively banned altogether, according to Guttmacher.

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