WASHINGTON (States Newsroom) — The future of medication abortion access in the United States went in front of the U.S. Supreme Court justices on Tuesday, where several justices appeared somewhat skeptical as anti-abortion organizations argued use of the pharmaceutical should be moved back to what was in place before 2016.
Solicitor General Elizabeth Prelogar, speaking on behalf of the federal government, told the conservative-dominated court that those restrictions would be unnecessary due to the numerous reputable studies that have shown mifepristone to be safe and effective.
Prelogar also argued that conscience protections already in place at the federal level protect doctors and other health care providers who don’t want to participate in elective abortion or in treating complications that can sometimes arise from medication abortion.
“Only an exceptionally small number of women suffer the kinds of serious complications that could trigger any need for emergency treatment,” Prelogar said. “It’s speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries. And even if that happened, federal conscience protections would guard against the injury the doctors face.”
Prelogar said there was no way to trace those two anti-abortion doctors’ concerns — cited in the case argued by Alliance Defending Freedom — about treating patients with complications from medication abortion to the changes the Food and Drug Administration approved in 2016 and 2021, which were at the center of the case before the Supreme Court.
Prelogar also said the anti-abortion legal organization that filed the original lawsuit hadn’t identified a situation where a doctor or health care provider opposed to abortion raised a conscience protection and then had that violated.
Medication abortion includes mifepristone as the first pharmaceutical and misoprostol as the second. The two-drug regimen accounted for about 63% of abortions within the United States in 2023, according to a report from the Guttmacher Institute.
Questions about broad changes in access
Justices Amy Coney Barrett and Neil Gorsuch — appointed to the court by former President Donald Trump — and Ketanji Brown Jackson, appointed by President Joe Biden — were among the members of the court who specifically asked about why conscience protections would or would not be an appropriate remedy to the anti-abortion doctors’ concerns about medication abortion.
“I’m worried that there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought,” Jackson said. “The obvious, common-sense remedy would be to provide them with an exemption that they don’t have to participate in this procedure.”
But, Jackson noted, the anti-abortion doctors were seeking changes in access to mifepristone for everyone in the United States.
“And I guess I’m just trying to understand how they could possibly be entitled to that, given the injury that they have alleged,” Jackson said.
Gorsuch appeared to express some criticism of the anti-abortion case as well, saying, “We have before us a handful of individuals who have asserted a conscience objection.”
“Normally, we would allow equitable relief to address them,” Gorsuch said. “Recently — and I think what Justice Jackson is alluding to — we’ve had, what one might call, a rash of universal injunctions or vacatures.”
“And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule, or any other federal government action,” Gorsuch said.
Prelogar agreed there was a “profound mismatch,” though Erin Morrow Hawley argued on behalf of Alliance Defending Freedom and the anti-abortion doctors that conscience protections don’t go far enough.
“These are emergency situations,” Hawley said. “Respondent doctors don’t necessarily know until they scrub into that operating room whether this may or may not be abortion drug harm — it could be a miscarriage, it could be an ectopic pregnancy, or it could be an elective abortion.”
Doctors, Hawley said, “can’t waste precious moments” in those circumstances.
Ruling coming later this year
The Supreme Court’s opinion on the case, Food and Drug Administration v. Alliance for Hippocratic Medicine, will likely arrive sometime early this summer in the middle of a bitter campaign for control of the White House and Congress in which the issue of reproductive rights is being stressed by Democrats.
The ruling will come about two years after the Supreme Court overturned the constitutional right to an abortion that it first recognized in the 1973 Roe v. Wade ruling and reasserted in the 1992 Casey v. Planned Parenthood decision.
Reverting use of mifepristone, one of two pharmaceuticals used in medication abortions, back to what was in place before the FDA began making changes in 2016 would lead to significant changes for doctors and patients:
- Mifepristone would be approved for up to seven weeks gestation, down from the current 10-week ceiling for use.
- Patients would go back to attending three, in-person doctor’s office appointments to complete the medication abortion process.
- The pharmaceutical could no longer be sent to patients through the mail.
- Only doctors would be able to prescribe mifepristone, removing the option for qualified healthcare providers like physician’s assistants and nurse practitioners to prescribe it.
The FDA originally approved mifepristone in 2000, later updating prescribing guidelines in 2016 and again during the COVID-19 pandemic.
Several major medical organizations — including the American College of Obstetricians and Gynecologists, the American Medical Association and the Society for Maternal-Fetal Medicine — wrote in a brief to the Supreme Court ahead of oral arguments that “(f)ocus on the use of mifepristone for induced abortion disregards how similarly essential it is to the safe and effective treatment of miscarriage or early pregnancy loss.”
“Miscarriage is common,” the medical organizations wrote. “Of the roughly 5.5 million pregnancies estimated to occur in the United States each year, between 10% and 26% end in miscarriage. For the million or more patients who experience early pregnancy loss annually, mifepristone is often a critical component of care.”
Thomas, Alito ask about Comstock Act
Associate Justices Clarence Thomas and Samuel Alito appeared to be more skeptical than some of their colleagues that mifepristone access should remain as it is now, including mailing it to some patients.
Both asked questions about the Comstock Act, a law from 1873 that sought to regulate obscenity, but also banned mailing “books on anatomy, works by British author D. H. Lawrence, information about contraception, and photographs of boxing matches,” according to a post from the National Archives.
Alliance Defending Freedom has argued throughout the case that the Comstock Act bars the mailing of mifepristone.
Hawley said that remains its position, disagreeing with the stance of the federal government and the legal counsel for a manufacturer of mifepristone.
“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 is pretty clear,” Hawley said.
Nothing the Supreme Court has ruled in its history “empowers FDA to ignore other federal laws,” Hawley said.
Prelogar said she didn’t believe that law fell within “FDA’s lane,” since under the Food, Drug and Cosmetic Act, that agency can only maintain enhanced requirements for pharmaceuticals like mifepristone if “necessary to ensure safe use.”
“I don’t think it would have even been permissible for FDA to consider maintaining this restriction because of Comstock,” Prelogar said. “It’s very clear that the only thing FDA can take into account for restrictions are safety and efficacy concerns in deciding whether to maintain a (Risk Evaluation and Mitigation Strategies) program.”
Jessica Ellsworth, legal counsel for Danco Laboratories LLC, which produces the brand-name version of mifepristone called Mifeprex, said she agreed with the assertion that FDA is only responsible to consider safety and efficacy.
The FDA, Ellsworth said, regularly approves pharmaceuticals “whose manufacture and distribution is restricted by other laws, like the Controlled Substances Act, environmental laws, customs laws.”
“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,” Ellsworth said.
Thomas said his “problem” with mailing mifepristone is that Danco is a private entity and that unlike the federal government, it “doesn’t have the sort of safe harbor that” she suggested.
Danco “disagreed” with that interpretation of the Comstock Act, Ellsworth said.
“This statute has not been enforced for nearly 100 years,” Ellsworth said. “And I don’t believe that this case presents an opportunity for this court to opine on the reach of the statute.”
Drug complications
Nearly all the justices asked questions of the three lawyers presenting the case Tuesday about the safety and efficacy of mifepristone.
One recurring question sought to determine when complications from using a pharmaceutical like mifepristone rise to the level where the FDA should pull it from the market.
Associate Justice Sonia Sotomayor noted “the problem with all drugs is there are complications in virtually all of them.”
“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?” Sotomayor asked.
Alito raised concerns about who would be in a position to rein in the FDA in the event it “flagrantly violated the law, didn’t do what it should have done, endangered the health of women.”
Prelogar said the FDA “takes very seriously its responsibility to ensure the safety of drugs” and noted there are other legal avenues besides the Supreme Court.
“We have a tort system in this country, and that can help ensure that if there are safety problems that come to pass, the sponsors will take action in reaction to that,” Prelogar said. “So if the premise here is that unsafe drugs could somehow remain on the market, I think that that’s incorrect.”
Alito appeared frustrated with some of the arguments in the case. He asked the legal counsel for Danco if the FDA was “infallible,” asked for information about times the FDA has had to pull approved medications from the market and asked why the FDA didn’t continue to require reporting of non-fatal adverse events after making changes to its prescribing guidelines in 2016.
Ellsworth said “the FDA decided not to continue that reporting requirement in 2016 based on more than 15 years of a well-established safety profile when that reporting was required.”
“There is no drug on the market today under any REMS that requires the kind of reporting that the plaintiffs are saying should be reimposed here,” Ellsworth said.
Justice Jackson later inquired about the “flip side” of Alito’s question on whether the FDA is infallible, asking “if courts have specialized scientific knowledge with respect to pharmaceuticals” and whether there should be concerns about judges “parsing medical and scientific studies.”
Ellsworth responded that pharmaceutical companies have laid out significant concerns in briefs about courts second-guessing or overturning the FDA’s scientific judgment.
“There are two amicus briefs from the pharmaceutical industry that expand on why exactly that’s so concerning for pharmaceutical companies who do depend on FDA’s gold standard review process to approve their drugs and then to be able to sell their products in line with that considered judgment,” Ellsworth said.
Among those concerns, she said, is that the U.S. District Court for the Northern District of Texas’ ruling in this case in 2023, which called for the complete removal of mifepristone from the market, used flawed reasoning.
“You have a district court that, among other things, relied on one study that was an analysis of anonymous blog posts,” Ellsworth said. “You have another set of studies that he relied on that were not in the administrative record and would never be because they post-date the FDA decisions here. They have since been retracted for lack of scientific rigor and for misleading presentations of data.”
That is one of the many reasons, she said, the FDA has “hundreds of pages of analysis in the record of what the scientific data showed. And courts are just not in a position to parse through and second guess that.”
