The Supreme Court heard oral arguments on Tuesday in a case that could have a significant impact on how mifepristone — the first drug used in a two-drug medication abortion regimen — is used and prescribed in the United States.
The case, FDA v. Alliance for Hippocratic Medicine, surrounds the U.S. Food and Drug Administration’s (FDA) rolling back of safety restrictions for mifepristone. Those restrictions include its 2016 actions extending the permissible gestational age of the baby for which a girl or woman may take abortion drugs from seven weeks gestation to ten weeks gestation, its elimination of requiring prescribers to report non-fatal complications from the drug, and its 2021 rule change allowing abortionists to send mifepristone through the mail. The FDA also recently made permanent its rule to allow women and girls to receive a prescription for mifepristone via telemedicine.
The Alliance Defending Freedom (ADF) filed the lawsuit in November of 2022 against the FDA on behalf of four national medical associations and several doctors, alleging the agency “chose politics over science and approved chemical abortion drugs for use in the United States.”
Justices agreed to take up the case in December of 2023. In September, both President Joe Biden’s Department of Justice (DOJ) and Danco Laboratories LLC, which distributes mifepristone under the brand name Mifeprex, asked the Supreme Court to reverse a decision from the U.S. Court of Appeals for the Fifth Circuit halting the 2016 and 2021 FDA actions that loosened restrictions on the abortion pill. The Supreme Court ultimately granted a consolidated hearing to both cases.
Despite the Fifth Circuit’s ruling against the government and the drug manufacturer, mifepristone has remained available under existing regulations while the litigation continues. The Supreme Court preemptively paused any ruling from an appeals court, pending a petition for the Supreme Court to take the case.
Hearing Highlights
A Question of Standing
Justices long dwelled on whether or not the doctors alleging harm in the case have standing to bring the challenge. Standing was one of the central arguments brought by U.S. Solicitor General Elizabeth Prelogar on behalf of the Biden administration.
“At the outset, respondents lack standing. They now concede they can’t rely on a statistical theory of injury like the lower courts did. Instead, they have to identify a specific doctor who faces imminent harm, but their theories rest on a long chain of remote contingencies,” Prelogar said in opening statements.
“And there’s no basis to conclude that any of that would be traceable to the incremental changes that FDA made in 2016 and 2021, as opposed to the availability of mifepristone in general. Respondent’s theories are too attenuated as a matter of law — the court should say so and put an end into this case,” she added.
Chief Justice John Roberts and Justices Clarence Thomas and Samuel Alito pressed Prelogar on her standing argument, asking whom the Biden administration would consider a legitimate challenger to the might of the FDA, or what marker of harm must be reached in order for a challenge to have standing.
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful — and maybe what they did was perfectly lawful — but shouldn’t somebody be able to challenge that in court? Who, in your view, who would have standing to bring that suit?” Alito asked.
Prelogar responded in part by saying it is “hard to identify anyone who would have standing to sue.”
“Your argument is that it doesn’t matter if FDA flagrantly violated the law, didn’t do what it should have done, endangered the health of women — it’s just too bad nobody can sue in court?” Alito continued. “There’s no remedy — the American people have no remedy for that?”
Prelogar argued that the specific respondents in the case do not “come within a hundred miles of the kind of circumstances this Court has previously identified of non-speculative harm that can create the kind of cognizable injury for forward-looking relief.”
Conscience Protections and Remedy
Erin Hawley, senior counsel at ADF, argued that respondents have standing because “doctors will be forced to manage abortions” because of the FDA’s decisions rolling back safety regulations.
“Drug harm is not a bug in the FDA system, but a part of its very design,” Hawley said in her opening statement. “Ruling against respondents on standing here would allow federal agencies to conscript non-regulated parties into violating their consciences and suffering other harm without judicial recourse.”
Justice Ketanji Brown Jackson — who could not define what a woman is in her confirmation hearing — questioned Hawley about whether restoring the 2016 and 2021 regulations is overly broad. Jackson specifically suggested that doctors’ concerns are already addressed by federal conscience protections.
“So what they’re asking for here is that in order prevent them from possibly ever having to do these kinds of procedures, everyone else should be prevented from getting access to this medication,” Jackson said. “So why isn’t that plainly over-broad scope of the remedy, the end of this case?”
Hawley argued that a narrow remedy, rather than addressing FDA actions would not be sufficient because emergency situations often do not allow for the invocation of conscience objections.
Justice Neil Gorsuch interrupted and added to Jackson’s line of questioning, noting that the case “seems like a prime example of turning what could be small lawsuit into a nationwide legislative assembly on an FDA rule.”
“I went back and looked, and there are exactly zero universal injunctions that were issued during Franklin D. Roosevelt’s, 12 years in office — pretty consequential ones. And over the last four years or so, the number is something like 60 and maybe more than that,” Gorsuch said. “And they are a relatively new thing, and you’re asking us to extend and pursue this relatively new remedial course, which this court has never adopted itself. Lower courts have kind of run with this.”
Justice Amy Coney Barrett questioned Prelogar about whether or not the Biden administration believes in conscience protections for doctors who do not want to perform abortions. Barrett referred to a case the High Court agreed to hear in April, which surrounds the Biden administration’s attempt to require emergency room doctors to perform abortions under its new interpretation of the Emergency Medical Treatment and Labor Act of 1986 (EMTALA).
“So I just want to be clear: the federal government’s position is that [respondent] doctor[s] would have conscience objections. I’m thinking about the EMTALA litigation and the Fifth Circuit criticizing the government’s inconsistent positions,” Barrett said. “But it is your position that such doctors would have recourse to the conscience protections of federal law?”
“Yes, absolutely,” Prelogar replied, claiming that the Fifth Circuit “did fundamentally misunderstand our arguments.”
Confronting the Merits of the Case
Justice Alito pressed both Prelogar and Jessica Ellsworth, who is representing Danco, on FDA actions and whether or not the agency can be held accountable.
Alito asked Prelogar why the FDA did not assess how making several changes to safety regulations at once could potentially increase risk.
“You say that the Fifth Circuit didn’t give any reason to think that the three changes made in 2016 would be more dangerous in combination than they were individually. But isn’t that obvious that three things that may be innocuous or not excessively dangerous, if engaged in by themselves, may become very dangerous when they’re all done together? And why shouldn’t the FDA have addressed that?” Alito asked.
Alito also referred to plaintiffs’ argument that the studies the FDA relied on for 2021 changes “suggest more frequent trips to the emergency room”:
Now this is what I see as the FDA’s response to that quote: ‘Although the literature suggests there may be more frequent emergency room care visits related to the use of mifepristone when dispensed by mail from the clinic, there are no apparent increases in other serious adverse events related to this mifepristone use.’
Does that really count as a reasoned explanation to the suggestion that the data shows there are going to be more emergency room visits? The increase in emergency room visits is just of no consequence? It doesn’t even merit some comment?
Justice Sonia Sotomayor also joined Alito in these concerns.
“On that last question — because that did trouble me — but the reality is, even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the FDA. Correct?” she questioned, to which Prelogar agreed.
Alito also peppered Ellsworth with questions about Danco’s interest in the case, pointing out that the company’s only drug is Mifeprex and that Danco stands to make more money if the 2016 and 2021 regulations are removed.
“So I gather your injury is that you think you’re going to sell more if the restrictions that previously were in place were lifted?” Alito asked, to which Ellsworth replied “yes.”
“So you’re going to make more money,” Alito continued.
“The injury is that we are prevented from selling our product in line with FDA’s scientific judgment about the safe and efficacious use of the drug,” Ellsworth argued.
Alito also asked if Ellsworth thinks “the FDA is infallible.”
“No, your Honor. We don’t think that at all, and we don’t think that question is really teed up in any way in this case,” she replied.
“Has the FDA ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences?” Alito continued.
“It has certainly done that,” she said.
Barrett and Alito also asked Danco and the Biden administration why the FDA did not continue to require reporting of non-fatal adverse outcomes.
“So why would that be a bad thing? Wouldn’t your company — you don’t want to sell a product that causes very serious harm to the people who take your product, relying on your tests and the FDA’s tests? Wouldn’t you want that data?” Alito asked Ellsworth.
Comstock Act
Justice Thomas and Alito asked every single attorney how the Comstock Act is implicated in the FDA’s decision to allow abortion pills to be in the mail. The Comstock Act is from the 1870s and prohibits sending abortion materials through the mail.
Alito asked Prelogar, “Shouldn’t the FDA have at least considered the application [of the Comstock Act]?” to which Prelogar argued that she does not think “it was the FDA’s responsibility to consider that.”
Justice Thomas similarly asked Ellsworth if the FDA and the drug company are violating Comstock.
“I think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies on the merits,” Ellsworth argued.
“Well, my problem is that you’re private,” Thomas pressed. “I understand the government’s argument, but you’re private, and the statute doesn’t have this sort of safe harbor that you are suggesting, and it’s fairly broad and specifically covers drugs such as yours.”
Thomas also asked Hawley about the role of the Comstock Act in the case.
Hawley said:
We don’t think that there’s any case of this court that empowers FDA to ignore other federal law, with respect to the Comstock Act. … The Comstock Act says that drugs should not be mailed either through the mail, or through common carriers. So we think that the plain text of that, your Honor, is pretty clear.
Other Allegations
The ADF’s lawsuit points to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000. The ADF alleges that the agency was only able to approve the drug by falsely classifying pregnancy as an “illness.” The lawsuit also alleges that the FDA never studied the safety of mifepristone under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded evidence that chemical abortion drugs cause more complications than surgical abortion, and eliminated necessary safeguards for pregnant girls and women who take the regimen.
The lawsuit details how, in 2016, the FDA extended the permissible gestational age for which a girl or woman may take the abortion drugs. Then, in 2021, the FDA allowed abortionists to send mifepristone through the mail, which the ADF says was “in direct violation of federal law.”
The complaint alleges:
All of the FDA’s actions on chemical abortion drugs — the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement — failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier. Instead, the FDA’s actions permitted and sometimes even encouraged these illegal activities.
The Fifth Circuit took up the case after U.S. District Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas handed down a 67-page decision that the FDA’s decisions were illegal under federal law, issuing a nationwide injunction blocking the abortion pill.
Days later, the U.S. Court of Appeals for the Fifth Circuit partially granted a stay requested by the Biden Justice Department. The court’s 42-page opinion temporarily put on hold the part of the decision about the 2000 FDA decision because it might be past the deadline for bringing legal challenges, though added that it was a “close call” and that the court might go the opposite direction after receiving additional legal arguments. But the appellate court rejected a stay on anything from 2016 to the present, affirming the trial court’s injunction.
The Supreme Court then put a hold on Kacsmaryk’s entire decision. As Breitbart News previously noted, an administrative stay is not in any way a reflection on the legal merits of the case. A Supreme Court justice can issue one just to preserve the status quo while the court is receiving arguments from both sides.
The Supreme Court declined to take up an appeal from the ADF asking justices to rule on the legality of the FDA’s 2000 approval of mifepristone.
How Does Mifepristone Work?
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Last week, the pro-abortion Guttmacher Institute released a report which found that medication abortions accounted for 63 percent of all abortions within the formal U.S. health care system in 2023 after the Supreme Court overturned Roe v. Wade — meaning an estimated 642,700 unborn babies died in medication abortions. The percentage is up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in red states.
The case is FDA v. Alliance for Hippocratic Medicine, No. 23-235 in the Supreme Court of the United States.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.