Federal judge stays FDA abortion pill approval, gives time to appeal

A federal judge in Texas on Friday suspended the Food and Drug Administration’s approval of the abortion pill mifepristone nationwide, but delayed the ruling from taking effect for a week to give the Biden administration time to appeal.

U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas held a key hearing in the case weeks ago in Amarillo, but the news of the decision that could upend access to the key abortion drug came down late on a Friday when many Americans were off for religious observances.

The FDA approved mifepristone more than two decades ago in 2000. Used in combination with another drug called misoprostol, mifepristone is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions. 

Kacsmaryk endorsed nearly all of the plaintiffs’ arguments about their right to sue, which called for the removal of the FDA’s approval of the drug. He argued mifepristone has serious safety issues, sidelining the FDA’s long-standing determination that the drug is safe and effective.

“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.” 

But in a dramatic turn, a federal judge in Washington state issued a preliminary injunction minutes after the Texas decision was announced that said essentially the opposite.

Judge Thomas Owen Rice of the U.S. District for the Eastern District of Washington barred the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” in the 17 states and D.C. that sued to keep pill on the market there.

The conflicting federal court rulings out of Texas and Washington state means the Supreme Court may ultimately weigh in on the legality of mifepristone in the U.S. 

U.S. Attorney General Merrick Garland said Kacsmaryk’s ruling in Texas  “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.” Garland said the Justice Department will appeal the Texas ruling and defend the FDA approval.

The case will go to the U.S. 5th Circuit Court of Appeals. If the Biden administration fails to convince that court to overturn Kacsmaryk’s ruling, access to mifepristone would be in jeopardy across the U.S.

But the ruling out of Washington state may protect access at least in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington state and D.C.

Kacsmaryk’s decision will not affect access to misoprostol, which is commonly used as a standalone abortion drug in other parts of the world. Some abortion providers have said they plan to use misoprostol as an alternative to the two-drug regimen if mifepristone is pulled from the market.

A coalition of physicians opposed to abortion called the Alliance for Hippocratic Medicine sued the FDA in November over its approval of mifepristone. The group argued that the FDA abused its authority by approving mifepristone through an accelerated process for new drugs that help patients with serious or life-threatening illnesses more than what is otherwise available on the market.

Kacsmaryk embraced the group’s claims Friday, arguing that pregnancy is not an illness and mifepristone does not provide a meaningful therapeutic benefit over surgical abortion.

The anti-abortion physicians were represented by attorneys from the Alliance Defending Freedom, an organization that worked with Mississippi lawmakers to draft the law at the center of Dobbs v. Jackson Women’s Health Organization. That case ultimately resulted in the Supreme Court overturning Roe v. Wade.

The FDA called the case “extraordinary and unprecedented” in its January response to the lawsuit. The agency’s lawyers said they could not find any previous example of a court second-guessing an FDA decision to approve a drug.

The agency also said mifepristone was not approved under an accelerated pathway. It took more than four years from the filing of the initial application until the pill was approved.

The FDA approved mifepristone as a safe and effective method to terminate an early pregnancy based on extensive scientific evidence, the agency’s lawyers wrote. Decades of experience among thousands of women have confirmed that the drug regimen is the safest option for many patients compared with surgical abortion or childbirth, the lawyers argued.

The FDA warned that pulling mifepristone from the U.S. market would put the health of women at risk if they cannot get access to the pill to safely end pregnancies. It would also weaken the FDA’s federal drug approval powers and hinder drug development by creating regulatory uncertainty in the marketplace, the government’s lawyers have said.

“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the Biden administration lawyers wrote.

Mifepristone has been subject to FDA restrictions since its approval in 2000 to monitor the pill’s safety and efficacy. These restrictions have been subject to criticism and litigation from medical associations such as the American College of Obstetricians and Gynecologists and more recently from attorneys general in Democratic- led states. 

The FDA has gradually eased the restrictions on mifepristone over the years as more evidence has come in. The agency dropped previous rules that required in-person visits with medical professionals, allowing the pill’s delivery by mail. The FDA recently allowed certified retail pharmacies to dispense mifepristone when the patient has a prescription from a health-care provider that’s approved under the agency’s monitoring program.

Misoprostol, the drug that’s used with mifepristone, is recommended as a stand-alone method to terminate a pregnancy by the World Health Organization. But the FDA has not approved misoprostol as an abortion medication on its own.

The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions if mifepristone is not available, though it’s not as effective as the two-drug regimen, according to the organization.