Legal experts are divided over how the Supreme Court will rule in an upcoming challenge to federal regulations that relaxed restrictions in 2016 and 2021 on the commonly used abortion pill mifepristone.
Advocates for mifepristone say the current system by which the drug is provided is safe, while opponents say it puts women at risk by ignoring the safety measures that used to be in place.
The Biden administration and pro-abortion groups worry that the Supreme Court’s eventual decision in the case could affect the availability of the drug.
At issue in the heavily litigated, complicated case are the Food and Drug Administration’s decision in 2016 to loosen prescription rules around mifepristone and then, in 2021, to allow prescriptions to be sent by mail without the patient first visiting a physician in person.
This newest case is a consolidation of two cases—Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM.
Danco Laboratories makes mifepristone, which also is known as RU-486.
The case is the Supreme Court’s most important abortion-related case since its June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which found that there was no right to abortion in the U.S. Constitution. That ruling overturned Roe v. Wade and returned the regulation of abortion to the states.
In a virtual repeat of 2022 with Dobbs, the decision is expected by June, at which point it could become a political issue in the November elections. It’s expected that if the court reimposes the old abortion pill restrictions, voters will blame Republicans, and Democrats will benefit politically.
In 2022, former President Donald Trump blamed Republicans’ mishandling of the abortion issue post-Roe for the GOP’s lackluster performance in the midterms.
“The analysis suggests that abortion worked as a counterweight to voters’ broader concerns about inflation, which favored Republican candidates,” Kaiser wrote.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol isn’t at issue in the current litigation.
Misoprostol is then taken 24 to 48 hours later to induce contractions to expel the pregnancy tissue. That drug is widely available because it is used for other purposes such as peptic ulcer disease prevention. Mifepristone, on the other hand, is more heavily regulated.
Case History
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald Trump, held in April 2023 that the FDA was wrong to approve mifepristone for public use in 2000 and that the agency had deliberately dragged out judicial review of the drug for years. The judge also found that the FDA had improperly lifted restrictions related to accessing the drug.Judge Kacsmaryk wrote that the FDA hadn’t properly assessed the risks posed by the drug before approving it, buckling under political pressure to get it on the market.
In this case, the FDA “acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions,” Judge Kacsmaryk wrote.
“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The FDA’s failure to impose restrictions on the use of the drug “resulted in many deaths and many more severe or life-threatening adverse reactions,” he wrote.
The drug has been in contention for years. In 2016, the FDA changed the drug’s label, extending the cutoff for its use from 49 days of gestation to 70 days. At the same time, the agency allowed the drug to be prescribed with only one in-person visit, and halted the requirement that prescribers report nonfatal adverse events related to the drug.
In 2019, the FDA approved a generic version of the drug. In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.
The U.S. Department of Justice appealed Judge Kacsmaryk’s decision, but the conservative-leaning U.S. Court of Appeals for the Fifth Circuit refused to block most of the order. The Fifth Circuit held that the FDA’s actions in 2016 and 2021 were probably unlawful—a finding that the FDA and Danco asked the Supreme Court to review.
In August 2023, the Fifth Circuit upheld the district judge’s restrictions on the abortion pill, holding that the FDA failed to give proper consideration to public safety concerns when approving it.
The Fifth Circuit noted that the Alliance for Hippocratic Medicine and the other plaintiffs argued they had “associational standing” because the various organizations involved in the lawsuit have members who “are likely to sustain injuries as a result of FDA’s actions.”
The court found the plaintiffs “made a ‘clear showing’ that their members face injury with sufficient likelihood to support entering a preliminary injunction.”
The Justice Department appealed to the Supreme Court, which blocked the injunction over the original approval of the drug, allowing mifepristone to remain on the market. Conservative Justices Clarence Thomas and Samuel Alito voted against lifting the injunction.
In September 2023, U.S. Solicitor General Elizabeth Prelogar urged the Supreme Court to act, saying that the Fifth Circuit’s ruling was the first time that a court had second-guessed the FDA’s “expert judgment” in approving medication.
The Case Against the FDA
The Alliance for Defending Freedom is representing the AHM, various medical associations, and several medical doctors, in the Supreme Court case.“These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing health care with the highest standards of excellence based on medical science,” it reads.
The Alliance for Defending Freedom senior counsel Erik Baptist told The Epoch Times that before 2016, the FDA had safety standards regarding mifepristone.
When the drug was first approved in 2000, the FDA required three in-person patient visits to a doctor. On the first day, the patient would receive the initial drugs, and on the third day, she would go to a clinic. Then there would be a 14th-day follow-up visit to ensure she had no life-threatening complications, he said.
But in 2016, the FDA took away two of the three required visits.
“The FDA no longer thought that a woman needs to have ongoing care by a doctor when she takes these drugs—you no longer do follow-up care visits to identify ... severe bleeding, or life-threatening infections,” Mr. Baptist said.
“The FDA never had a study showing the safety of all these changes that it made in 2016. It removed the doctor from the equation. So no longer does the doctor have to be involved at all in this process.
“And then in 2021, the FDA took away that first initial screening to identify conditions that should preclude a woman from taking these drugs such as a life-threatening ectopic pregnancy that if it’s not diagnosed could rupture.”
Sometimes women taking mifepristone experience pain but they don’t realize the pain is being caused by an undiagnosed ectopic pregnancy, and when they call the abortion provider to report this, they are told that such pain is part of the medication abortion process, he said.
“Historically, women have made that mistake, and some women have actually died,” he said, because they didn’t get medical attention for the ectopic pregnancy.
“So what the FDA has now permitted is just doctor-less—no opportunity to have an office visit to be screened before or after taking these drugs. It’s not the care that women deserve and what they need when they take these drugs. And that’s why we’ve sued over it.”
Legal Standing
Law professor and legal historian Mary Ziegler of the University of California–Davis School of Law told The Epoch Times that the first obstacle the AHM will have to overcome at the Supreme Court is the issue of standing.Standing consists of a connection to and harm from the action challenged to justify a litigant’s participation in a lawsuit.
If you read the 5th Circuit decision “clearly everybody thinks standing is a major issue … because there’s some concerns that the Alliance for Hippocratic Medicine doesn’t have standing and its members don’t have standing,” she said.
The fact that the Supreme Court left access to the drug in place during the litigation “isn’t that revealing, but usually the court is supposed to think about who’s likely to win on the merits in deciding whether to freeze or change the status quo.”
Allowing continued access to the drug “implies that the court has at least some questions” about the AHM’s case “and probably the most logical question to have would be a question about standing.”
Although the justices may be sympathetic to the claim, “you have to remember conservatives on the court are sticklers for standing, usually,” Ms. Ziegler said.
“They usually think it’s pretty hard to establish their party standing to the satisfaction of someone like [Justice] Neil Gorsuch, so I think that’s really a heavy lift for the plaintiffs here.”
Conservative justices believe “you have to have a more imminent injury than just the possibility that people might do this thing,” she said.
Veteran Supreme Court observer Curt Levey, president of the conservative Committee for Justice, said AHM is mounting “a strong challenge” but standing may be a problem.
Although the fact that the plaintiffs are “not themselves taking the abortion drug” is “an argument worth making,” the plaintiffs “do a good job of pushing back on that.”
Mr. Baptist said he’s hopeful on the issue of standing, an issue that “about 75 percent” of the other side’s briefs focus on.
Administrative Procedure Act
The AHM brought its lawsuit against the FDA under the federal Administrative Procedure Act (APA).Under the APA’s test, courts review agency actions to determine if they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” If an agency action meets the test, it can be invalidated.
Mr. Baptist said the agency has to provide a reasonable explanation for its action.
“You have to have adequate information or sufficient information, adequate testing, and substantial evidence of safety and effectiveness of the drug under the prescribed conditions of use,” he said.
“They studied a regimen that they’d never actually approved and so the FDA failed to follow ... the [federal Food, Drug, and Cosmetic Act] on studying the conditions of use and hadn’t seen substantial evidence of safety.
“So it was doubly illegal for that reason.”
The FDA refuses to admit wrongdoing, he said.
The agency’s responses so far in this case are “that they’re above reproach, and they don’t make mistakes, and courts are not allowed to second-guess their decisions.”
“But in our constitutional republic, we have checks and balances where Congress delegates authority to the executive branch, the executive branch executes on that delegated authority through the statutes which empower those agencies,” Mr. Baptist said.
“And when the agencies fail to follow what Congress told them to do, it is absolutely incumbent upon the courts and the judiciary system to hold those unlawful agency actions accountable.”
Mr. Levey said politics definitely was a factor in the FDA’s 2016 and 2021 decisions to loosen mifepristone regulations.
“I don’t think there’s much doubt about that. And certainly, the Supreme Court’s not going to be naive about that,” he said.
“Anyone looking at this knows that it was a rushed, politically motivated decision.
“The whole point of the APA is to force agencies to go through a rigorous analytical process and to address the arguments on both sides and not to rush and not to do things for political reasons.”
Although abortion pill critics have good arguments, whether the FDA actions comport with the APA “is a close call.”
“It’s about 50–50. I wouldn’t be surprised by it going either way.”
Legal challenges to agency actions under the APA used to be “long shots, but that’s not true anymore,” Mr. Levey said.
If this challenge had been brought before 2016, “I would predict that the Supreme Court would be very deferential to the FDA and overrule the Fifth Circuit,” he said.
But the legal environment has changed because “during the Trump administration, activists and willing district court judges went after virtually every Trump regulation and executive order under the APA,” Mr. Levey said.
“People who thought that everything the Trump administration did was a threat to democracy brought up a ton of APA challenges and they would pick venues—California, Hawaii—where they get very sympathetic district court judges who would issue nationwide injunctions.
“And that ushered in an era of less deference to administrative agencies under the APA.”
In late April 2023, Senate Majority Leader Chuck Schumer (D-N.Y.) responded to Judge Kacsmaryk’s ruling, and others he had made that Democrats opposed, by threatening to push legislation that would discourage alleged forum shopping by Republican litigants. Democrats claim Texas makes it unusually easy for conservative plaintiffs to seek out sympathetic jurists such as Judge Kacsmaryk.
Jim Burling, vice president of legal affairs for the Pacific Legal Foundation, questioned whether the Supreme Court would accept the argument that the FDA violated the APA.
The FDA regulations “were done in a hurry because they had a goal to achieve,” he said.
“So to me, it’s actually a pretty close question of whether or not the FDA properly went through the proper channels or [followed] proper procedures,” Mr. Burling said.
“What you have to do under the Administrative Procedure Act, and various statutes that apply to the FDA, are rather complicated at times. And if you don’t dot all the i’s and cross all the t’s properly, an administrative action may be declared unlawful by a court, and that is what is before the Supreme Court here.”
Ms. Ziegler said: “People obviously disagree about whether the FDA made the right call, but I don’t know if, given the evidence, it rises to the level of ‘arbitrary and capricious.’
“I just don’t know if I think courts are competent to make that call.
“Conservatives have said for years, ‘We don’t want to have imperial courts. We don’t want courts acting as de facto medical boards.’
“And if the court is reviewing thousands of pages of evidence about mifepristone, that sounds like what it is to me. So I don’t know how comfortable I am with courts being the ones making that call.”
She said that accepting the plaintiffs’ APA arguments could open a “Pandora’s box where people who don’t like whatever drug for whatever other reason start going to court and saying the FDA acted arbitrarily and capriciously.”
