Access to abortion pill in limbo after conflicting rulings by federal judges in Texas and Washington

For now, the drug mifepristone that the FDA approved in 2000 appeared to remain at least immediately available. The Biden administration plans to appeal the Texas ruling.

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Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Ala., March 16, 2022. A federal judge in Texas on Friday, April 7, 2023, ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval. Federal lawyers representing the FDA are expected to swiftly appeal the ruling.

AP Photo/Allen G. Breed, File

AUSTIN, Texas — Access to the most commonly used method of abortion in the United States plunged into uncertainty Friday after conflicting court rulings over the legality of the abortion medication mifepristone, which has been widely available for more than 20 years.

For now, the drug that the federal Food and Drug Administration approved in 2000 appeared to remain at least immediately available in the wake of rulings issued by federal judges in Texas and Washington.

In the Texas ruling, U.S. District Judge Matthew Kacsmaryk, a Donald Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval.

That decision came at nearly the same time U.S. District Judge Thomas O. Rice, a Barack Obama appointee, essentially ordered the opposite in the Washington case, directing U.S. government authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats had sued in an effort to protect the drug’s availability.

The extraordinary timing of the orders highlighted the high stakes surrounding the drug nearly a year after the U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country.

President Joe Biden said his administration would fight the Texas ruling.

“The court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription approved by the FDA that would be safe from these kinds of political, ideological attacks.”

The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.

“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.

Abortion providers including Whole Woman’s Health, which operates six clinics in five states, slammed the Texas ruling. Whole Women’s Health said it would continue to dispense 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 securing FDA approval.

Mifepristone is one of two drugs used for medication abortion in the United States. The other: misoprostol, which also is used to treat other medical conditions.

There’s essentially no precedent for a lone judge overruling the medical decisions of the FDA.

Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.

He didn’t go as far as the plaintiffs wanted by withdrawing or suspending approval of the chemical abortion drug and removing it from the list of approved drugs.

Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the United States.

Clinics and doctors that prescribe the combination have said they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies but is widely used in countries where mifepristone is illegal or unavailable.

The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which also was involved in the Mississippi Dobbs vs. Jackson case that led to the landmark Roe v. Wade decision being overturned.

At the core of the lawsuit is the accusation that the FDA’s initial approval of mifepristone was flawed because it didn’t adequately review its safety risks.

Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing.

Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including their assertion that the FDA didn’t adequately review mifepristone’s safety.

“The court does not second-guess FDA’s decision-making lightly.” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

Mifepristone has been used by millions of women over the past 23 years, and complications from the drug occur at a lower rate than that seen with wisdom-teeth removal, colonoscopies and other routine medical procedures, medical groups have noted.

But Kacsmaryk sided with the plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, calling it a “natural process essential to perpetuating human life.”

His order also agreed with the plaintiffs in invoking a controversial 19th century law that anti-abortion groups are trying to revive to block sending abortion medications through the mail. Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a right under federal law to abortion.

Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.

His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.

In late 2021 the FDA — under the Biden administration — dropped a requirement that required women to pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January, the agency dropped another requirement, which prevented most brick-and-mortar pharmacies from dispensing the pill.

Anti-abortion groups, which are newly encouraged about their ability to further restrict abortion and prevail in court since last’s year’s reversal of Roe v. Wade, embraced the Texas ruling.

“The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs,” said Jeanne Mancini, president of the group March for Life.

Legal experts said the ruling could upend decades of precedent, setting 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 huge deal,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second-guessing every scientific decision that the FDA made.”

Still, because of the contradictory nature of the rulings, Donley and other experts said there would be little immediate impact.

“In the short term, nothing’s going to change,” Donley said. “This is the time to be preparing for the fact that, in a week, potentially, mifepristone becomes an unapproved drug in this country.”

Democrats and abortion rights groups slammed the ruling out of Texas.

“Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” California Gov. Gavin Newsom said.

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