Access to Abortion Pill in Limbo After Competing Rulings as Biden, Newsom Slam Texas Judge

Updated 2 p.m. Saturday

Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following 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 Food and Drug Administration approved in 2000 remains at least immediately available in the wake of the separate rulings that were issued just minutes apart by federal judges in Texas and Washington.

U.S. District Judge Matthew Kacsmaryk, a Trump appointee and formerly an attorney for a religious liberty legal group with a long history of pushing conservative causes, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision was quickly followed by U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordering the opposite and directing U.S. authorities to not make any changes that would restrict access to the drug.

“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.

The extraordinary timing of the competing orders revealed the high stakes that surround the drug 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.”

Gov. Gavin Newsom’s office issued a statement Friday condemning the decision by the “far-right federal judge.”

“Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law — putting the health of millions of women and girls at risk,” said Newsom. “Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away.”

In a press release Friday, Attorney General Rob Bonta called the ruling in Texas “unconscionable” and “another chapter in a very dark period of American history,” saying, “I will continue doing everything in my power to ensure that our state remains a safe haven for all those seeking, supporting, and providing reproductive care,” and reminding Californians of their reproductive rights.

U.S. Rep. Barbara Lee (CA-12), co-chair of the Pro-Choice Caucus, issued a press statement in which she called the Texas judge’s decision part of a coordinated and decades-long attack on abortion rights in the country.

“If the Supreme Court upholds this extreme and dangerous ruling, it will be the greatest loss for abortion rights since the fall of Roe … We can’t let that happen,” said Lee. “As Co-Chair of the Pro-Choice Caucus, I am working closely with our partners to respond to this egregious ruling and preserve access to mifepristone nationwide. People — not politicians — should have the freedom to make their own health care decisions, and we won’t stop fighting until they do.”

Senator Dianne Feinstein (D-Calif.) issued a statement Saturday saying the ruling in Texas wasn’t about the “safety of the drug or protecting patients” but about “overriding the FDA’s processes and expertise to attack women’s reproductive rights.”

Abortion providers also slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.

President and CEO Jodi Hicks of Planned Parenthood Affiliates of California said the ruling was in stark contrast to public opinion.

“Attacks on reproductive health care, including medication abortion, are all about power and control, and this is no different,” said Hicks in an interview with KQED. “This ruling will create additional barriers to care, and people will be hurt by this. But let’s be clear, despite this ruling and the efforts of extremists, abortion remains legal and accessible in California. Planned Parenthood in California will continue to support Californians and out-of-state patients seeking care they need here.”

In a statement Friday, American Medical Association President Dr. Jack Resneck Jr., said “the court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm.”

“By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians,” said Resneck. “Mifepristone has been studied extensively for over two decades and has been proven to be safe time and time again … We will continue to support access to evidence-based health care, including abortion medication, and oppose intrusions that undermine our patients’ health.”

The abortion drug has been widely used in the U.S. since 2000, and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

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.

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it 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 was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not 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 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 recently noted.

Elsewhere, Kacsmaryk sided with 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, instead calling it a “natural process essential to perpetuating human life.”

His order also agreed with plaintiffs in invoking a controversial 19th-century law that anti-abortion groups are now 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 federal right 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 patients pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January the agency dropped another requirement that 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 March for Life President Jeanne Mancini.

Legal experts warned that 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.”

This story includes reporting by Paul J. Weber, Matthew Perrone and Lindsay Whitehurst of The Associated Press and by Azul Dahlstrom-Eckman and Attila Pelit of KQED.