Just after a Texas judge ordered the the Food and Drug Administration (FDA) to invalidate its decades-long approval of abortion pill mifepristone, a Washington state judge ordered the agency to keep the drug available.
In Amarillo, Texas, U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump amid controversy over his outspoken anti-abortion rights and anti-LGBTQ+ views, on Friday ordered the FDA to invalidate its year 2000 approval of mifepristone, effectively banning all sales of the drug after seven days.
Kacsmaryk's ruling would apply to every U.S. state, including those where abortion remains legal following last year's Supreme Court decision to reverse Roe v. Wade.
In Washington state, less than an hour after Kacsmaryk ruled, Spokane-based U.S. District Judge Thomas Rice—an appointee of former President Barack Obama—issued a ruling in a separate case that blocks the FDA from taking "any action to remove mifepristone from the market or otherwise cause the drug to become less available," according to The New York Times.
It is unclear how the dueling decisions will affect the fate of the drug, which is likely to remain available, at least in the short term, as both rulings are appealed.
Although mifepristone was approved more than 22 years ago, the anti-abortion groups who filed the Texas lawsuit claimed that the FDA "chose politics over science" and ignored safety concerns, particularly involving minors, when approving the drug.
Abortion-rights advocates have deemed the argument disingenuous, pointing out that there have been few actual safety concerns about the drug during the many years that it has been legal.
Multiple major medical organizations filed an amicus brief in the Texas suit, in support of the FDA's position, arguing that "hundreds of medical studies and vast amounts of data amassed over the course of two decades" have shown that the drug is "exceedingly safe."
"Serious side effects occur in less than 1 percent of patients, and major adverse events— significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients," the brief states. "The risk of death is almost non-existent."
Attorney General Merrick Garland condemned the Texas decision and vowed to file an appeal, while noting that the Department of Justice was "reviewing" the Washington state decision and was "committed to protecting Americans' access to legal reproductive care."
"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 Friday night.
"Today's decision overturns the FDA's expert judgment, rendered over two decades ago, that mifepristone is safe and effective," he continued. "The Department will continue to defend the FDA's decision."
In a statement to Newsweek, an FDA spokesperson said that the agency had appealed Kacsmaryk's decision and "believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses."
"FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use—medical termination of early pregnancy," the spokesperson said.
"The approval was based on the best available science and done in accordance with the laws that govern our work," they continued. "FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy."
An appeal of Kacsmaryk's ruling will be decided in the 5th Circuit Court of Appeals, a famously conservative court that features a majority of judges appointed by Republican presidents.
The 9th Circuit Court of Appeals, where an appeal to Rice's decision would be heard, has a more liberal reputation, with the court's current composition featuring slightly more Democratic than Republican appointees.
The approval status of mifepristone may ultimately be decided by the conservative majority of the Supreme Court, which already displayed its anti-abortion inclinations by overturning Roe last year.
Even if mifepristone is blocked from continued FDA approval, there may still be legal options for the drug to be prescribed and provided to those who want it.
In addition, mifepristone is often taken in conjunction with the drug misoprostol, which is not facing the prospect of a ban and is capable of inducing abortions by itself, albeit with more side effects.
Update 4/7/23, 11:37 p.m. ET: This article has been updated to include a statement from the FDA.
Uncommon Knowledge
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Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
About the writer
Aila Slisco is a Newsweek night reporter based in New York. Her focus is on reporting national politics, where she ... Read more
