Abortion medication decision could upend FDA approval process, abortion rights
What plaintiffs targeting abortion pill want might not even be possible
Photo by Phil Walter/Getty Images.
At the center of the federal anti-abortion lawsuit against the U.S. Food and Drug Administration is the abortion drug mifepristone and the regimen that reportedly accounts for the majority of abortions in post-Roe America. That’s why the whole country is bracing itself for a ruling from a notoriously anti-abortion judge in Amarillo, Texas.
The attention and confusion around this case might end up being the most impactful aspects about it, as many legal scholars doubt the judge has the legal authority to do what plaintiffs are asking for, which boils down to forcing the FDA to essentially recall a drug that for two decades has maintained a record of efficacy and safety. But regardless of the lawsuit’s outcome, legal experts still think a ruling that even briefly or partially favors plaintiffs will likely have lasting consequences on U.S. abortion access and affect medication policy beyond abortion.
“What this case is doing is only increasing the politicization of mifepristone and abortion, as well as the entire FDA approval process, and [it’s] calling into question the impartiality and the legitimacy of our court system, as well as our FDA approval process,” Georgia State University law professor Allison M. Whelan told States Newsroom.
Last month Whelan along with 18 other FDA legal scholars co-signed a “friend of the court” brief on behalf of the FDA, arguing that U.S. District Judge Matthew Kacsmaryk doesn’t have the authority to force the FDA to immediately withdraw approval of mifepristone, which plaintiffs have asked him to do via preliminary injunction while the rest of the lawsuit unfolds.
Theoretically, the judge could decline to order the total withdrawal of the drug but could grant some of plaintiffs’ other demands, which include ordering the FDA to reinstate regulations that were lifted within the past several years. In 2000 the FDA approved a medication abortion regimen involving the hormone blocker mifepristone followed by misoprostol to expel the pregnancy. Later the FDA extended the gestational age that this protocol could be used from seven weeks to 10, eliminated the in-person dispensing requirement, and most recently has allowed pharmacies to dispense the drug directly to patients under certain restrictions — though that policy is still being rolled out.
The FDA scholars and other legal experts say the process to withdraw drug approval (or to undo decisions made around a drug) can take years, requires public input, and discretion ultimately falls to the FDA. And in the meantime, the agency could choose whether or how to enforce any order that the drug is unapproved, said Whelan, whose scholarship and teaching focus includes FDA law and reproductive justice.
“[T]he FDA would issue this policy statement that signals for manufacturers that from the FDA’s perspective, the FDA is not going to bring any sort of a civil or criminal action against the company for continuing to sell their drug,” Whelan told States Newsroom. “The FDA has issued enforcement discretion policies many times, including recently with the infant formula crisis.”
Even Kacsmaryk questioned his own powers during last Wednesday’s injunction hearing.
“[I]s it that you expect this Court to order the FDA to begin a suspension or withdrawal, almost like a writ-type scenario, or that the Court itself can withdraw or suspend on its own accord?” Kacsmaryk asked, according to the court transcript.
“The latter,” replied Erik Baptist, senior counsel for Alliance Defending Freedom, the conservative Christian legal shop representing plaintiffs. “We take the position that the Court, on its own accord, can order the FDA to withdraw or suspend the approval of the drug.”
“And explain to me your argument on why this Court has that sweeping authority,” Kacsmaryk replied.
Baptist replied vaguely that the court has the power to “enjoin and take whatever action to prevent harm.”
Despite plaintiffs’ claims that medication abortion is dangerous, there is ample evidence of its efficacy and safety. In more than two decades, there have been 28 reported deaths associated with mifepristone and a generally low rate of adverse events, according to the FDA.
The issue of drug approval is just one among several reasons defendants (and legal analysts) argue the case should be thrown out. Others include that the statute of limitations on plaintiffs’ complaints has expired and that plaintiffs did not exhaust administrative remedies to challenge FDA’s approval of mifepristone.
Attorneys for the government have argued that plaintiffs do not have standing to bring their claims and have not shown how they would be directly harmed by keeping mifepristone on the market. Plaintiffs have largely argued that doctors represented in the lawsuit might see an increase in workload in their emergency rooms if more medication abortion patients experience complications and seek medical treatment. Even if that were a viable argument, plaintiffs have not provided evidence that medication abortion is causing a large amount of adverse effects and problems – beyond speculation and minimal anecdotes.
Plaintiffs have also asked the court to weigh in on a dormant federal law from the 1800s known as the Comstock Act, which anti-abortion advocates have been trying to argue legally prevents abortion pills from being sent in the mail, but the Biden administration contests this. Defendants have argued that whether a drug can be legally mailed has no bearing on this case about drug approvals.
A Trump appointee, Kacsmaryk previously served as deputy counsel for a Christian conservative legal group called First Liberty Institute, where he worked on cases fighting access to reproductive access. As a federal judge, Kacsmaryk has struck down protections for LGBTQ workers and trans youth and ruled that a federal family planning program’s policy of offering confidential birth control to teens violates federal law and Texas state law, putting that state program in jeopardy (the ruling has been appealed). But given all of the legal problems with the abortion pill case, legal journalist Chris Geidner suggests there are a lot of reasons why this case could fail, despite Kacsmaryk’s ideology and sympathies to some of the plaintiffs’ arguments
“Anything could happen — and much has been made of Kacsmaryk’s background and rulings thus far on the bench — but DOJ and Danco’s lawyers made as strong a case as possible that Kacsmaryk would be going far afield of the law by doing anything about the 2000 approval of mifepristone, especially with these plaintiffs on these facts.”
This case is ongoing (as are several federal lawsuits about medication abortion), and Kacsmaryk’s preliminary injunction is likely to be appealed. Additionally, the ruling itself would only apply to the FDA and Danco Laboratories, one of the manufacturers of the abortion pill. Still, a decision that favors the coalition of national conservative Christian medical associations known as the Alliance for Hippocratic Medicine, and the four plaintiff doctors is sure to have far-reaching legal consequences, and could add more distress and confusion for manufacturers, pharmacists and health care providers. Beyond abortion, Whelan said a favorable decision could open the door to lawsuits against politically controversial vaccines and hormone replacement therapies.
A favorable decision could also embolden more states to try to ban mifepristone using the argument – if Kacsmaryk buys it – that the medication abortion regimen was not lawfully approved or properly vetted, which many legal and policy analysts say is patently false. A ruling that limits medication abortion in some way – even if it’s not enforceable – will add yet another confusing legal layer to the panoply of state anti-abortion laws that have led to pregnant women frantically traveling for abortion care outside their states, even for medical emergencies.
“It’s like there is no light at the end of the tunnel as to when this is going to end, and it’s just so problematic from a patient and provider perspective because of the uncertainty,” Whelan said. “I cannot imagine being a healthcare provider who does reproductive health care going to work every day thinking, ‘Can I do this today? I was allowed to do it yesterday. Can I do it today? Will I be able to do it tomorrow?’”
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