Anti-abortion coalition asks Supreme Court to allow restrictions on mifepristone

WASHINGTON — An anti-abortion coalition urged the Supreme Court on Tuesday to leave in place a lower court decision that would prevent patients from obtaining the abortion pill mifepristone by mail amid other new restrictions.

The groups, led by the Alliance for Hippocratic Medicine, said in a filing that the court should leave in place a ruling last week by the 5th U.S. Circuit Court of Appeals that would suspend several regulatory decisions by the Food and Drug Administration since 2016 that made it easier to obtain the drug.

Lawyers for the groups wrote that the FDA over decades has "stripped away every meaningful and necessary safeguard on chemical abortion, demonstrating callous disregard for women’s well-being, unborn life, and statutory limits."

They dismissed the government's "sky-is-falling argument" about the implications of allowing the lower court ruling to go into effect.

"The lower courts’ meticulous decisions do not second-guess the agency’s scientific determinations; they merely re- quire the agency to follow the law," the lawyers wrote.

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

The Justice Department and Danco Laboratories, which makes the brand version of mifepristone, Mifeprex, had asked the high court to immediately step in and block the lower court ruling.

To win, the Biden administration would need the votes of at least five of the nine justices on the court, which last summer in a 5-4 ruling overturned 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, which is made by GenBioPro.

The FDA’s 2016 changes 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 challengers 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. The court 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 the District of Columbia, which sued in February challenging the FDA’s regulations over the drug.

Both lower court rulings in the Texas case 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 were applied to other drugs, it would upend the “settled regulatory framework and the investments that hinge upon it.”

Kacsmaryk’s decision 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.

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

A majority of abortions in the U.S. are carried out using 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 last year to overturn Roe v. Wade, some conservative states have enacted tough abortion restrictions that already make it difficult, if not impossible, to terminate pregnancies, whether by accessing pills or undergoing surgical procedures. Abortion is effectively banned altogether in 12 states, according to Guttmacher.