Judge’s Ruling to Invalidate Abortion Pill Ruling Could Impact Other FDA-Approved Drugs
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, says Nicole Huberfeld, Edward R. Utley Professor of Health Law, Bioethics & Human Rights at the BU School of Public Health and a professor at the School of Law. Brigette Supernova / Alamy Stock Photo
Judge’s Ruling to Invalidate Abortion Pill Ruling Could Impact Other FDA-Approved Drugs
The abortion drug mifepristone is still lawful and available for now, says BU LAW professor, but she calls the ruling “part of the broad strategy to make it nearly impossible to have an abortion in the United States”
No federal court has ever “second-guessed the science” behind the US Food and Drug Administration’s approval of a medication, says Boston University health law professor Nicole Huberfeld—until now.
On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in a decision that shocked many legal experts. Huberfeld, who is the Edward R. Utley Professor of Health Law, Bioethics & Human Rights at the BU School of Public Health and a law professor in the School of Law, says it was an unprecedented move that calls into question more than just the future of medical abortions.“This is a clear separation-of-powers problem,” she says. “The court—and really, this judge—doesn’t have the expertise to second-guess the FDA in this way.”
The ruling concerns mifepristone, the first of a two-drug protocol for a medical abortion. And while Judge Matthew J. Kacsmaryk’s decision came down on April 7, both drugs typically used during the procedure (the other is misoprostol) are still available throughout the United States. Kacsmaryk stayed, or delayed, his order for seven days to give the federal government time to appeal the ruling.
That didn’t take long. The Department of Justice immediately filed an intent to appeal, calling the decision “extraordinary and unprecedented.” And, 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.”
Additionally, some states, including Massachusetts, have taken preemptive steps to stock up on the two drugs required for medical abortions. Governor Maura Healey said Monday that the state put in an order for close to two years’ worth of mifepristone last week, before Kacsmaryk’s decision even came out.
Still, the ruling rattled many.
“This is really just an attack on bodily autonomy,” says Shana Weitzen (Pardee’25), who is the Planned Parenthood liaison for BU Students for Reproductive Freedom. “It’s not about the drug. This is going to be an attack across the country. It can be a really scary time, but people have to remain hopeful and have to educate themselves and learn about the organizations that are working on the ground.”
While for now the target is abortion care, this ruling (if it stands) could reverberate far beyond one drug, Huberfeld says. 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.”
“They’re right to be alarmed,” Huberfeld says. “You could see the same thing play out in debates over vaccines or other medications. So, I do think that this is potentially problematic in a number of dimensions.”BU Today spoke with Huberfeld further about the ruling, and its impact across healthcare.
Q&A
with Nicole Huberfeld
BU Today: 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. What does that mean?
Huberfeld: The “asks” were slightly different in these cases—in other words, the litigation is positioned differently.
The decision in Texas is a challenge to the FDA’s original approval of mifepristone 20 years ago, by physicians who would never prescribe it in the first place. So, there are questions as to whether they even have what’s called standing, meaning whether they can even be in court. The Texas litigation is very big-picture.
My understanding is that the Washington litigation was filed, partially at least, in response to the Texas litigation, by Democratic attorneys general who wanted to make sure that mifepristone would continue to be available in the states in which they have official duties. They asked the federal court to ensure that the FDA does not tighten mifepristone rules in their states.
BU Today: Let’s go back—you mentioned that the doctors in the Texas case wouldn’t prescribe mifepristone. Why not?
They’re anti-abortion doctors. Specifically, they’re part of the Alliance for Hippocratic Medicine, as they call themselves. They are expressly anti-abortion doctors, who incorporated in a very specific part of Texas to get this case before this judge in the Northern District of Texas.
So, this was not just forum shopping, which is the practice of choosing to bring a case in a jurisdiction that you think will be most favorable to it. This was judge shopping—trying to figure out which judge is most likely to rule in your favor, which is itself problematic, as well.
BU Today: Is that rare? Can you explain that a bit more?
It’s not uncommon for lawyers to try to figure out where they’re going to get a favorable ruling, and to try to locate litigation where they think they may get favorable judges. So, broadly speaking, the judges in the Ninth Circuit, or California, tend to be more progressive than the judges in the Fifth Circuit, or Texas. So, forum shopping, as it gets called, is not new, and it’s not unusual. But this is a little different in that the strategy was so specific. This organization of anti-abortion doctors was specifically formed in this town of Amarillo, where only one federal judge sits, so that this judge—who was well known to be a person who has been anti-abortion his entire life—would hear this case.
BU Today: So, to what extent is this decision a testament to that anti-abortion belief, as opposed to a reaction to the merits of the case?
The decision is riddled with language that reflects the anti-abortion movement. It contains nonscientific language—instead of using “medication abortion” or “medical abortion,” the judge uses the phrase “chemical abortion,” which is not how it gets referred to by doctors, for example. There are also instances of calling an embryo or fetus an “unborn human being.” So, the language is very much anti-abortion movement language. And that is reflective, I think, of the totality of the opinion, which is written in such a way that this judge appears to be outraged that the FDA ever would have considered approving the mifepristone in the first place.
BU Today: Can you put this case within the context of that broader anti-abortion movement?
It is part of the broad strategy on the part of anti-abortion organizations to make it nearly impossible to have an abortion in the United States. So, that’s the big picture. This is their long-term, 50-year strategy. And this is just one front in that strategy.
BU Today: What comes next? Do you see this going to the US Supreme Court?
It certainly could. I mean, it is irreconcilable, the decisions that are being issued by lower federal courts, and that is a standard circumstance in which the US Supreme Court would take a case. But let’s be clear, as of right now, mifepristone is available. I think people need to know that: this is still lawful and available.
Lindsay Shachnow contributed to this report.
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