Biden DOJ to Appeal Abortion-Pill Case to Supreme Court
The Biden administration announced Thursday that it will make an appeal to the Supreme Court challenging this week’s ruling that reinstituted limits on the access and delivery of abortion pills.
The announcement comes after Wednesday night’s ruling by the Fifth Circuit Court of Appeals that restored the 2016 limits on mifepristone, one of two drugs used in a chemical abortion. Among the changes the FDA made in 2016, it increased the gestational age for the drug from seven weeks to ten, allowed non-doctors to prescribe abortion pills, and reduced the number of required office visits necessary to obtain the pills from three to one.
In 2019, the FDA approved a generic version of the abortion pill regimen, and in 2021, during the Covid-19 pandemic, it allowed the pills to be dispensed through the mail. Those changes are now on hold, though the three-judge appeals panel preserved the FDA’s initial approval of mifepristone.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a prepared statement. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
Lawyers for Alliance Defending Freedom, the conservative legal firm that represented the pro-life doctors and medical groups, called the appeals panel’s ruling a win for their cause.
“The Fifth Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” ADF lawyer Erin Hawley told reporters on Thursday morning.
Hawley said they have no plans to appeal the ruling, which allows the FDA’s 2000 approval of mifepristone to stand for now. On Friday, U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, overturned the 2000 approval of the drug. But in its preliminary ruling, the appeals court determined that the statute of limitations to challenge the 2000 approval likely expired.
ADF lawyers argue that changes the FDA has made in in 2016, 2019, and 2021, should allow them to reopen and challenge the initial approval of the drug in 2000.
“At this point we are happy to let the lower courts go back and look at our 2000 claim,” Hawley said of their decision not to appeal. “We think we’ve got really good arguments, as the Fifth Circuit acknowledged. But for the moment, this is a huge win for our plaintiff doctors and the patients they represent.”
She also rebuked lawmakers who have called on the FDA and federal authorities to simply ignore rulings limiting abortion pill access and delivery. Senator Ron Wyden (D., Ore.), and representatives Alexandria Ocasio-Cortez (D., N.Y.), and Nancy Mace, (R., S.C.), have each called for that.
“That’s a call to complete lawlessness,” Hawley said. “We’ve heard that from a number of different political figures, and I think it’s a really dangerous precedent for one branch to suggest that another branch should fully disregard the decisions of the other branch, of the judiciary in this case.”
Hawley argued that the process to approve mifepristone was lawless from the start, and it that it was based on politics. Then-president Bill Clinton aggressively lobbied for the drug’s approval.
“And now you have certain people weighing in to say we should just ignore the federal courts, making it clear that this was about politics rather than about women’s safety,” she said.
Developed in France in the 1980s, the chemical-abortion process involves two pills: mifepristone, a progesterone blocker that kills the unborn baby by depriving it of nutrients, and misoprostol, which causes uterine contractions to empty the uterus.
To approve mifepristone under what is called “Subpart H” regulations – accelerated approval, which allows for post-approval safety measures – the FDA concluded that pregnancy is a “life-threatening illness.” ADF argues that the FDA had no business approving the two-drug regime under Subpart H because pregnancy is not an illness but is a “normal physiological state that many females experience one or more times during their childbearing years.”
The ADF lawsuit also claims the FDA failed to properly study the safety of the regimen, and for almost two decades it stonewalled the doctors who were attempting to challenge the approval of the regimen. Rather than increase scrutiny of the pills, the FDA has eliminated safeguards that did exist and has made the drug easier to obtain.
More than half of all abortions in the U.S. are now done using chemical-abortion pills.
