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Abortion Drug Remains Approved, With Restrictions, Appeals Court Rules

Mifepristone, a common abortion-inducing drug, will remain approved but under more intense restrictions while a legal challenge proceeds, a federal appeals court ruled late Wednesday. The 5th U.S. Circuit Court of Appeals halted parts of a controversial court order that was set to go into effect Friday night, while affirming other parts.

U.S. District Judge Matthew Kacsmaryk of Amarillo ruled a week ago that mifepristone, a common abortion-inducing medication, was improperly approved by the Food and Drug Administration in 2000.

In a 2-1 ruling, the 5th Circuit judges agreed with the Department of Justice, which argued too much time had passed to challenge the 2000 approval of the drug. But the defendants, a group of anti-abortion doctors and medical associations, were still within the statute of limitations to challenge changes made to the drug’s approval in 2016 and 2022, the court ruled. While the case proceeds, the court returned the drug’s status to before those more recent changes.

That means mifepristone will remain on the market, but approved only for use up to seven weeks of pregnancy, versus 10 weeks, and it cannot be prescribed by telehealth or mailed. The Biden administration lifted the in-person dispensing requirement late last year, in an effort to expand abortion access in the wake of the overturn of Roe v. Wade. While mailing abortion pills was already illegal in Texas, even before this ruling, the return of this restriction is expected to limit access for Texans seeking the medication in other states or illicitly.

Complicating matters is a conflicting court ruling out of Washington state, issued just 20 minutes after the Texas ruling, ordering the FDA to not change mifepristone’s legal status. That ruling is binding only in the 17 states that filed the lawsuit, while Kacsmaryk’s ruling is nationwide. The FDA has asked the Washington judge to clarify how both rulings align with each other.

Mifepristone, when used alongside another medication called misoprostol, is the most common way Americans terminate their pregnancies. Countless studies have shown the medication to be safe and effective, with minimal adverse effects, but it has emerged as a focal point for anti-abortion advocates who see it as a workaround to state abortion bans.

“This Texas case was brought as the next step to ban abortion nationwide,” said Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project. “If Judge Kacsmaryk gets away with his attempt to undo the approval of mifepristone for the entire nation, the effect will be felt in all 50 states, even where abortion is legal and protected.”

The Texas ruling’s impact

Kacsmaryk’s ruling, which relied heavily on anti-abortion language and studies, has confounded legal, medical and FDA experts.

“This is the first time a judge has unilaterally, against the FDA’s objections, removed a drug from the market,” Greer Donley, a University of Pittsburgh law professor who studies FDA law, told The Texas Tribune. “A judge who has … no scientific expertise, overruling the agency that has a ton of scientific expertise.”

The ruling was celebrated by the anti-abortion movement, as well as conservatives who have been increasingly critical of the so-called “administrative state,” including agencies like FDA.

“The FDA put women and girls in harm’s way and it’s high time the agency is held accountable for its reckless actions,” said Erik Baptist, senior counsel for the Alliance Defending Freedom, the conservative Christian law firm that brought the suit. “The FDA never had the authority to approve these hazardous drugs and remove important safeguards.”

Dr. Jane Henney, the FDA commissioner when mifepristone was approved, told reporters Monday that this ruling could set a “very dangerous precedent” for the FDA’s ability to approve drugs without fear of judicial interference.

“Clearly, we would be entering totally uncharted territory in that regard,” Henney said.

More than 400 leaders of drug and biotech companies signed on to a letter this week condemning the ruling on similar grounds.

“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” the letter reads.

What comes next

Kacsmaryk’s original ruling intended to revert mifepristone’s status to 2000, before it was an approved drug.

If that went into effect, drug makers could ask the FDA to reapprove the medication, relying on decades of studies and real-world usage data to prove that it is safe and efficacious. But that’s a potentially long and arduous process.

“We could, in reality, be facing a scenario where this medication is only available in a clinical trial setting and not available to patients in the real world for upwards of two, maybe three years, even if everybody wants to move,” Kirsten Moore, director of the Expanding Medication Abortion Access Project, told reporters Monday. “It’s deeply upsetting to think about.”

The FDA could also use its enforcement discretion and say it will not go after anyone who manufactures or dispenses mifepristone, potentially blunting the immediate turmoil this ruling might cause. But that would likely remain in place only as long as there is a Democrat in the White House.

“The effect of the district court’s decision, if it was allowed to take effect, is to essentially put FDA approval on ice,” said Pincus. “That opens the door to potential liability for manufacturers and other people, and it’s not clear that enforcement discretion is a route to … give them the assurance they need.”

Amid the uncertainty, some abortion providers are preparing to stop offering medication abortion, while others intend to use misoprostol alone, which has a greater risk of side effects and complications than when taken alongside mifepristone.

As some legal scholars have pointed out, the continued availability of misoprostol means the alleged harm these doctors are facing from treating patients who have undergone medication abortions will not be solved by removing mifepristone from the market. In fact, it may actually increase the likelihood that they have to treat complications and incomplete abortions.

“To me, this ends the TX case,” tweeted David Cohen, an FDA and reproductive rights expert at Drexel University’s law school. “If abortion providers are going to continue to use misoprostol (which they are), then all the harms that the Texas plaintiffs alleged will continue (if not more so). This case fails redressability, a basic requirement of federal court standing.”

This story originally appeared on the Texas Tribune. To read this article in its original format, click here.

Eleanor Klibanoff, The Texas Tribune
Eleanor Klibanoff, The Texas Tribune
Eleanor Klibanoff is the women's health reporter at The Texas Tribune. She was previously with the Kentucky Center for Investigative Reporting, where she covered sexual assault, domestic violence and policing, among other things.


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