Dueling Federal Rulings Leave Abortion Drug Access in Limbo

A federal court in Texas has ruled that the 23-year-old FDA approval of mifepristone should be overturned. But a federal court in Washington has ruled the FDA must continue to make the drug available in some states. Mifepristone is one of two pills used in medication abortions and is used in the vast majority of such abortions in the United State. The drug was approved in 2000 and has proven a safe and effective way to end pregnancy when used with another medication, misoprostol.

The Texas Ruling and National Implications

On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in an unprecedented move. Because the ruling overturns a federal drug approval, the medication may lack approval everywhere, regardless of a given state’s abortion laws. Texas Judge Matthew Kacsmaryk, who ruled in favor of the conservative group, stayed, or delayed, his order for seven days to give the federal government time to appeal the ruling. The Department of Justice immediately filed an intent to appeal, calling the decision “extraordinary and unprecedented.”

In a statement following Kacsmaryk’s decision, President Joe Biden said that the “court in this case has substituted its judgment for FDA, the expert agency that approves drugs. 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.”

The Washington Ruling and State Protections

Just an hour after Judge Kacsmaryk ruled on this case, another federal judge in Washington state issued what seems like a contradictory ruling in a separate case. The judge in that case, Thomas Rice, on Friday granted a motion that enjoins the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in the states that have filed that lawsuit. Oregon Attorney General Ellen Rosenblum and Washington Attorney General Bob Ferguson filed their own lawsuit against the FDA, alleging the agency had singled out mifepristone for excessive regulation. Rosenblum said on Twitter: “The federal judge in the eastern district of Washington JUST granted our request to preserve access to Mifepristone pending the outcome of our case.”

Medical and Industry Response

Jack Resneck, President of the American Medical Association, also condemned the Texas decision. In a written statement, Resneck said mifepristone has been studied extensively and used by millions of people for over two decades and is proven to be safe. “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,” Resneck said. No federal court has ever “second-guessed the science” behind the US Food and Drug Administration’s approval of a medication—until now. Already, more than 400 executives from the pharmaceutical industry have signed on to a statement condemning Kacsmaryk’s ruling, writing that it “creates uncertainty for the entire biopharma industry.”

Comparison of Federal Court Rulings

The following summary highlights the key differences between the two rulings issued on April 7, 2023:

• Texas District Court (Judge Kacsmaryk): Ruled that the 23-year-old FDA approval of mifepristone should be overturned and invalidated.
• Washington District Court (Judge Rice): Granted a motion that enjoins the FDA from altering the status quo as it relates to the availability of Mifepristone in participating states.
• Legal Status: The abortion drug mifepristone is still lawful and available for now, as the Texas ruling was stayed for seven days to allow for an appeal.
• State Action: More than a dozen states with Democratic attorneys general signed on to the Washington suit to ensure mifepristone continues to be available.

Potential Risks to Public Health

Oregon Sen. Ron Wyden said the harm that would be caused by banning access to mifepristone would be irreparable. If the ruling were to stand, professor Nicole Huberfeld notes, “You could see the same thing play out in debates over vaccines or other medications.” For now, the Oregon Health Authority wants to reassure patients and providers that mifepristone and abortion remain safe, legal and available in Oregon.