AUSTIN, Texas (AP) — Access to the most common method of abortion in the U.S. plunged into uncertainty Friday following different court rulings on the legal abortion drug mifepristone, which has been around for more than 20 years.
For now, two thousand Food and Drug Administration-approved drugs appear to remain at least immediately available in the wake of two separate regulations issued in succession by federal judges in Texas and Washington.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal mifepristone approval in a decision that overruled decades of scientific approval. But that decision came at about the same time that U.S. District Judge Thomas O. Rice, Obama’s nominee, essentially ordered the opposite. and ordered US authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats contended it would be available to protect the drug.
The extraordinary timing of the order to compete revealed the highest stakes surrounding the drug nearly a year after the Supreme Court overturned Roe v. Wade and helped access to abortion throughout the country.
The Department of Justice quickly announced that Texas would appeal the ruling and said it had reviewed the plan from Washington.
A spate of conflicting decisions is likely to send the issue on an accelerated path to the Supreme Court.
“The FDA is under one order that says you don’t do anything, and another that says in seven days, I’m going to require you to deliver the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
The Texas government has pushed abortion providers, including Whole Woman’s Health, which operates six clinics in five states and said it will continue to dispense mifepristone in person and by mail next week when it reviews regulations.
Abortion drugs are widely used in the US with FDA approval and there is essentially no precedent for the Food and Drug Administration’s sole medical judge prevailing. Mifepristone is one of two drugs used as abortion drugs in the United States, along with misoprostol, which is also used to treat other medical conditions.
Kacsmaryk signed an injunction to direct the FDA to stay approval of mifepristone while a lawsuit challenging the drug’s safety and approval continues. His 67-page order gave the government seven days to appeal.
“Today’s decision overturns the FDA’s expert judgment, which was rendered two decades ago, that mifepristone is safe and effective,” said US Attorney General Merrick Garland. “The Department will continue to defend the FDA’s decision.”
Clinicians and doctors who prescribe the combination of drugs said that if mifepristone were pulled from the market, they would use only misoprostol as a second drug. The single drug approach is slightly less effective in terminating pregnancies, but is widely used in countries where mifepristone is illegal or widespread.
The lawsuit was filed in Texas by the Alliance to Defend Freedomwhich was also cited in the case of Mississippi, which was referred to in Roe v. Wade was overthrown. The lawsuit alleges that the FDA’s initial approval of mifepristone was flawed because it did not adequately assess its health risks.
Hall has long deferred to the FDA on questions of drug safety and efficacy. But the agency faces new challenges in the post-Roe legal environment in which abortions are banned or restricted in 14 states, while 16 states have laws specifically excluding abortion drugs.
Since the Texas case was filed in November, legal experts have warned of the evidentiary problems and inaccuracies in the Christian group’s filing. Kacsmaryk essentially agrees with the plaintiffs on all major points, including that the FDA does not adequately review the safety of mifepristone.
“The court did not second-guess the FDA decision lightly.” Kacsmaryk wrote. “But here, the FDA acquiesced to its legitimate safety concerns, as opposed to its legitimate duty — with a completely insane rationale 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 occur in less than those seen with wisdom teeth removal, colonoscopy and other conventional medical procedures, a group of doctors recently noted.
Elsewhere, Kacsmaryk sides with the plaintiffs, claiming that the FDA overstepped its authority in approving mifepristone, in part, through a special drug review action used to treat serious or life-threatening illnesses. The judge rejected the FDA’s arguments that its own regulations declare pregnancy to be a medical condition that can sometimes be serious and life-threatening, instead calling it a natural process essential to sustaining human life.
His order also agreed with plaintiffs in invoking a controversial 19th-century law that anti-abortion groups now use to prevent abortion drugs from being sent through the mail. Originally passed in 1873 and dubbed the “anti-vice crusader,” the Comstock Act was used to ban carriers of contraceptives, “playable” prescriptions, and “instruments” that could be used in abortions. The law was rarely invoked in the 50 years after Roe established the federal right to abortion.
Kacsmaryk, although the plaintiffs agree that the law – as properly interpreted – prohibits the mailing of mifepristone.
His order, if upheld, would also undermine several recent FDA actions that provide easier access to drugs.
As recently as 2021, the FDA — under the Biden administration — dropped the requirement that women pick up their medications in person, opening the door to electronic pharmacy delivery. In January, the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.
The anti-abortion group, which has been newly emboldened by its ability to restrict abortions and prevail in court since last year’s reversal of Roe v. Wade, the reigning embrace of Texas.
“Today’s decision is a major step forward for women and girls whose health and safety have been threatened for decades by the FDA’s aggressive, flawed and politically motivated approval of dangerous drugs,” said March for Life President Jeanne Mancini.
Legal experts have warned that the ruling could go back decades, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.
“This has never been done before in history — it’s a lot,” said Greer Donley, a professor of reproductive health care at the University of Pittsburgh School of Law. “You have a federal judge who has no scientific background second-guessing every scientific decision that the FDA made.”
Yet because of the conflicting nature of the issues, Greer and other experts said there was little impact.
“In the short term, nothing has to change,” Greer said. “This is the time to prepare that mifepristone potentially in a week, the drug becomes approved in this country.”
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It was reported by Perrone and Whitehurst in London. He contributed to the Associated Press reporter Gene Johnson in Seattle.
