Abortion Drug Remains Approved with Restrictions
By Eleanor Klibanoff, The Texas Tribune
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. The Department of Justice said Thursday it will seek emergency relief at the U.S. Supreme Court to get the entire original order stayed.
U.S. District Judge Matthew Kacsmaryk of Amarillo ruled a week ago that mifepristone 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’s argument that 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, as well as the approval of a generic version of the medication, the court ruled. While the case proceeds, the court reinstated the previous regulations.
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 via telehealth or mailed. Patients have to attend three, in-person doctors visits to obtain the medication, per the FDA approval in 2000. 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 Alliance Defending Freedom, a conservative law firm that brought the suit, celebrated the ruling as a win, but acknowledged the legal battle was far from over.
“For now, we've got a great victory in the fact that there are now three required doctor visits to make sure women are safe and that the FDA complies with the rule of law,” said counsel Erin Morrow Hawley.
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 should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls,” Hawley said. “Federal agencies that act lawlessly must be held accountable.”
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
Wednesday’s ruling, which addressed just the administrative stay, is the beginning of what will likely be a lengthy legal process. First, the Supreme Court will have to decide whether to take up the Department of Justice’s request for emergency intervention before the remaining aspects of Kacmsaryk’s ruling go into effect at midnight on Friday.
Either way, the case will still need to proceed through the courts on its merits. The 5th Circuit has expedited oral arguments, meaning the three-judge panel will soon hear arguments about whether Kacmsaryk’s ruling should stand at all.
If the ruling does eventually go 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 article originally appeared in The Texas Tribune at https://www.texastribune.org/2023/04/13/texas-fda-abortion-drugs/.
