Federal Judge's Ruling Threatens Access to Abortion Drug Mifepristone

A Texas federal judge's ruling may limit women's reproductive healthcare options across the United States. Future access to medical abortion is uncertain for 64 million American women of reproductive age, even those living in states where abortion is legal, after a pair of contradictory rulings were filed on April 7 in separate federal courts.

About the rulings

U.S. District Judge Matthew J. Kacsmaryk, of Amarillo, Texas, a Donald Trump presidential appointee, issued a preliminary decision revoking the U.S. Food and Drug Administration's (FDA) two-decade-old approval of the drug mifepristone, one of two prescription medications, along with misoprostol, used in medical abortions. In the case, Alliance for Hippocratic Medicine v. FDA, the judge sided with the plaintiffs' claim that the FDA didn't appropriately vet the drug before its approval in 2000.

Making the mifepristone matter a bit more complicated, less than an hour after Kacsmaryk filed his decision, U.S. District Judge Thomas O. Rice, a Barack Obama appointee in Washington state, filed a contradictory ruling in a separate case. It's a multistate federal lawsuit filed in February in the Eastern District of Washington by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum. Rice's ruling declared the FDA should not make any changes that could restrict access to the abortion medication in states that legally allow abortion.

The timing of the two rulings will likely send the issue of mifepristone's legality to the U.S. Supreme Court.

How did we get here?

Less than a year after the U.S. Supreme Court's decision in Dobbs v. Jackson Women's Health Organization essentially overturned Roe v. Wade, the precedent that long protected a woman's constitutional right to abortion care, America's most common form of abortion is in legal peril even in states where abortion is legal.

In a 67-page ruling, Kacsmaryk sided, in part, with the Alliance for Hippocratic Medicine, an Amarillo-based nonprofit group with anti-abortion ties, invalidating the FDA's 23-year-old approval of the medication mifepristone. The judge's ruling alleges the FDA "stonewalled judicial review until now," putting women at risk of side effects from mifepristone.

The Biden administration and medical organizations, including the American Medical Association (AMA), were quick to issue statements denouncing Kacsmaryk's decision.

"The court, in this case, has substituted its judgment for FDA, the expert agency that approves drugs," President Joe Biden said in a statement regarding the Texas ruling on April 7. "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."

U.S. Attorney General Merrick Garland said the Justice Department would continue to defend the FDA's decision regarding the abortion pill.

"The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court's decision and seeking a stay pending appeal," Garland said in a statement on April 7. "Today's decision overturns the FDA's expert judgment, rendered over two decades ago, that mifepristone is safe and effective…The department is committed to protecting Americans' access to legal reproductive care."

What's next in the abortion medication rulings?

The Department of Justice, representing the FDA, had seven days to file an appeal before the Texas ruling went into effect. It filed the appeal April 10.

"[The ruling in Texas] flies in the face of science and evidence and threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years," said AMA President Jack Resneck Jr., M.D., in a statement. "The court's disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians."

The doctor said the Texas decision could have wide-reaching ramifications.

"Additionally, this decision introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration," Resneck said. "Doing so goes against the established scientific process that leads to those decisions and puts other drugs at risk of being subject to similar efforts. Substituting the opinions of individual judges and courts in place of extensive, evidence-based, scientific review of efficacy and safety through well-established FDA processes is reckless and dangerous."

Potential ramifications

Resneck said mifepristone has been "studied extensively" and proved safe for more than two decades.

By prohibiting mifepristone, he said patients would be forced to consider "a less effective treatment" using a higher dose of misoprostol on its own.

"There is no evidence that people are harmed by having access to this safe and effective medication," Resneck said in his AMA statement. "To the contrary, there is substantial evidence that the denial of needed abortion care without justification carries a psychological, physical and economic toll. For people who do not have access to procedural abortion or adequate medical facilities, there may be no other options to obtain critically needed care.

"Current data show an association between restricted access to safe and legal abortion and higher rates of maternal morbidity and mortality, with already vulnerable populations experiencing the greatest burden," Resneck continued. "Reduced access to mifepristone will almost certainly exacerbate the maternal mortality crisis in places that do not have access to this medication."

The AMA has vowed to not let this ruling affect how it approaches care.

"We will continue to support access to evidence-based healthcare, including abortion medication, and oppose intrusions that undermine our patients' health," Resneck said.