Access to the most widely used abortion method in the United States fell into uncertainty on Friday after conflicting court rulings over the legality of the abortion drug mifepristone, which has been widely used for more than 20 years.
For now, the drug, approved by the Food and Drug Administration in 2000, appeared to remain at least immediately available after two separate rulings issued in quick succession by federal judges in Texas and Washington.
U.S. District Judge Matthew Kacsmaryk, a Trump-appointed representative, ordered the suspension of mifepristone’s federal approval in a decision that overruled decades of scientific approval. But that decision came almost at the same time that US District Judge Thomas O. Rice, an Obama-appointed representative, ordered essentially the opposite, directing US authorities not to make any changes that would limit access to the drug in at least 17 years would restrict states where Democrats sued to protect availability.
The extraordinary timing of the competing orders revealed the high stakes surrounding the drug almost a year after the US Supreme Court Roe v. Wade and restricted abortion access across the country. President Joe Biden said his administration will fight the Texas verdict.
The lashing of the conflicting decisions will likely put the matter on an accelerated path to the Supreme Court.
“The FDA is subject to one order stating there is nothing you can do and another stating that in seven days I will ask you to delist mifepristone,” said Glenn Cohen of Harvard Law School.
Abortion providers have criticized Texas’ ruling, including Whole Woman’s Health, which operates six clinics in five states, and said it will continue dispensing mifepristone in person and by mail over the next week as they review the rulings.
The abortion drug has been widely used in the United States since it received FDA approval, and there is essentially no precedent for a single judge overruling the Food and Drug Administration’s medical decisions. Mifepristone is one of two drugs used for abortion medication in the United States, along with misoprostol, which is also used to treat other conditions.
Kacsmaryk signed an injunction ordering the FDA to stay approval of mifepristone while a court case challenging the drug’s safety and approval continues. Its 67-page order gave the government seven days to appeal.
“The court substituted its judgment in this case for the FDA, the expert agency that approves drugs,” Biden said. “Should this ruling stand, there will be virtually no FDA-approved prescription that would be safe from such political, ideological attack.”
Clinics and doctors who prescribe the two-drug combination have said that if mifepristone were withdrawn from the market, they would switch to using just the second drug, misoprostol. This single-drug approach has slightly less effectiveness in terminating pregnancy, but is often used in countries where mifepristone is illegal or unavailable.
The Texas case was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that resulted in Roe v. Wade is knocked over. At the heart of the lawsuit is the allegation that the FDA’s original approval of mifepristone was flawed because the safety risks were not adequately reviewed.
Courts have long turned to the FDA on drug safety and efficacy issues. But the agency’s board faces new challenges in a post-Roe legal environment where abortion is banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion drugs.
Ever since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s lawsuit. Kacsmaryk essentially agreed with the plaintiffs on all key points, including that the FDA did not adequately review mifepristone’s safety.
“The court does not lightly challenge FDA’s decision-making,” Kacsmaryk wrote. “But here the FDA has acknowledged its legitimate safety concerns – in breach of its legal duty – on the basis of patently unsound arguments and studies that did not support its conclusions.”
Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone are less common than with wisdom teeth extractions, colonoscopies, and other routine medical procedures, medical groups have recently found.
Elsewhere, Kacsmaryk sided with the plaintiffs, stating that the FDA partially overstepped its powers in approving mifepristone by using a special review process reserved for drugs used to treat “serious or life-threatening diseases.” The judge dismissed the FDA’s arguments that its own regulations clarify that pregnancy is a disease that can sometimes be serious and life-threatening, instead calling it a “natural process essential to the maintenance of human life.”
His injunction also agreed with the plaintiffs’ invoking a controversial 19th-century law that anti-abortion groups are now trying to revive to block abortion drugs from being sent through the mail. Originally passed in 1873 and named after an “anti-vice crusader,” the Comstock Act was used to ban the shipment of contraceptives, “salacious” writing, and “instruments” that could be used in an abortion. The law has rarely been enforced in the 50 years after Roe introduced a federal abortion law.
However, Kacsmaryk agreed with the plaintiffs that the law, as interpreted literally, prohibits mifepristone from being shipped.
His order, if upheld, would also nullify a number of recent FDA actions aimed at increasing access to the drug.
In late 2021, the FDA — under the Biden administration — dropped the requirement for women to pick up the drug in person, opening the door to mail-order pharmacy delivery. In January, the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.
Anti-abortion groups that have existed since the repeal of Roe v. Wade, accepted the Texas verdict.
“Today’s court decision is a major step forward for women and girls whose health and safety have been at risk for decades from the FDA’s hasty, erroneous and politicized approval of these dangerous drugs,” said Jeanne Mancini, president of March for Life .
Legal experts warned that the ruling could upset decades of precedent and set the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.
“This has never happened before in history — it’s a big deal,” said Greer Donley, a professor of reproductive health at the University of Pittsburgh Law School. “They have a federal judge who has no scientific background and guesses every scientific decision the FDA makes after the fact.”
However, due to the conflicting nature of the rulings, Donley and other experts said there would be little immediate impact.
“Nothing will change in the short term,” Donley said. “This is the time to prepare for the fact that mifepristone may become an unapproved drug in this country in a week.”
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