The Supreme Court is set to hear oral arguments March 26 in a case involving mifepristone, a pill commonly used in medication abortion. If the court rules to revoke the drug’s U.S. Food and Drug Administration approval or restrict its distribution, that will make abortion harder to access for many people. But the potential repercussions of the case go far beyond reproductive rights.
If the court sides with antiabortion activists and limits or bans the use of mifepristone, the decision could undermine the FDA’s authority to regulate all drugs and medical devices, potentially putting people who depend on those products at risk of harm.
By second-guessing the FDA, the Court could “set a dangerous precedent” and “open the floodgates” to lawsuits from political activists seeking to overturn the approvals of everything from contraceptives to vaccines to gender-affirming care, says Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University. Some of the first targets for conservative activists, he says, could be intrauterine devices (IUDs), which are placed in the uterus for up to 10 years to prevent pregnancy, as well as an over-the-counter contraceptive called Plan B, also known as the “morning-after pill,” which can prevent pregnancy within 72 hours after sex.
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Such lawsuits could lead to chaos for doctors and patients and could deter researchers from trying to introduce new medical treatments, Gostin says. State court decisions could lead to certain drugs and medical devices being banned in some states but not others. Limiting the availability of essential medications could cost lives, Gostin says.
“It is extraordinarily important that the FDA has the power to set a national uniform standard for all vaccines and drugs based solely on science and evidence,” Gostin says. “The last thing the public needs is for these scientific decisions to be micromanaged by [layperson] judges.”
The FDA approved mifepristone in 2000. In 2016 the agency extended the window of use for mifepristone from the first seven weeks of pregnancy to the first 10 weeks. In 2021 the agency removed a requirement for mifepristone to be dispensed in person that had already been halted in 2020 and allowed the drug to be delivered through the mail nationally for abortion purposes.
The original lawsuit against the FDA was filed in November 2022 in Texas, a few months after the Supreme Court struck down Roe v. Wade, the landmark 1973 decision that legalized abortion nationwide. In that lawsuit, a coalition of antiabortion doctors and organizations, the Alliance for Hippocratic Medicine, claimed that the agency overlooked safety concerns when it approved mifepristone more than two decades ago and when it lifted restrictions on access to the drug in 2016 and 2021.
A pivotal issue in the Supreme Court case is whether the antiabortion doctors have legal standing to sue, says Mary Ziegler, a professor at the University of California, Davis, School of Law, who studies the history of abortion. Although the doctors who brought the suit don’t perform abortions, they claim they have standing to sue because they could potentially treat people who go to the emergency room for serious complications caused by mifepristone.
“You can’t just bring a lawsuit because you don’t like something,” Ziegler says. “You have to show that you yourself are going to suffer some sort of concrete injury.” If the Court decides the coalition lacks standing, it could dismiss the case, Ziegler says. Last year two lower courts found that the alliance did have standing to sue. Two of the studies on which one of those lower courts relied have since been retracted because of serious flaws and conflicts of interest, however.
Reducing Telemedicine Abortion Access
Mifepristone has been used by more than five million people in the U.S. since its approval, and hundreds of studies attest to the drug’s safety. Analyses show that mifepristone has a better safety profile than Tylenol, penicillin and Viagra. And recent research finds that mifepristone is equally safe and effective when it’s provided through telehealth.
If the Supreme Court takes mifepristone off the market, people will have more difficulty obtaining an abortion, even in states where it remains legal, says Daniel Grossman, a professor of obstetrics and gynecology at the University of California, San Francisco. Requiring that mifepristone be dispensed by a doctor during an in-person visit would make it difficult or impossible for rural residents to access the drug, Grossman says. Although telemedicine has only been an option for mifepristone access since 2020, 16 percent of all medication abortions are now provided through telehealth.
Mifepristone is used in combination with a second drug, misoprostol, in most medication abortions. Medication abortion accounted for 63 percent of all pregnancy terminations in the U.S. in 2023. Although medication abortions can be performed with misoprostol alone, this method is somewhat less effective and more likely to cause side effects, such as nausea, vomiting, diarrhea and possibly pain, Grossman says. People who undergo misoprostol-only abortions are more likely to require additional medication or procedures to complete the abortion.
If the Supreme Court rolls back the FDA rules that changed the prescribing window or dose, doctors could continue to prescribe it that way off-label, a practice in which drugs are prescribed in ways for which they are not approved. But Ziegler says that the FDA has authority to issue fines and criminal penalties for violations of food and drug law. Under a new administration, the FDA could deem existing supplies of mifepristone to be “misbranded” because their label would reflect the 2016 and 2021 changes rather than the original 2000 label. A court decision could stop anyone from distributing or marketing mifepristone until drug companies took steps to bring its label into compliance with the new legal status, which could take time.
“That’s another way where [the president] elected in 2024 will make a difference in abortion access,” Ziegler says. While the Biden administration is unlikely to prosecute drug manufacturers or doctors for straying from the new rules, Ziegler says that a future president could make that a priority. “Doctors’ ability to continue prescribing mifepristone could depend on who is in the White House,” she adds.
Turning Back the Clock on Abortion Access
When the U.S. Court of Appeals for the Fifth Circuit considered the mifepristone case last year, its judges took exception to the FDA’s claim that the agency’s scientists should decide which drugs are safe and effective. The court wrote, “Their message is simple: The scientists at the FDA can do no wrong. So courts have no business reviewing their actions.... But scientists are human beings just like the rest of us. They’re not perfect.... We all make mistakes.”
The appeals court left in place the FDA’s original approval of mifepristone, noting that lawsuits about a drug that’s been on the market for more than two decades are “likely barred by the statute of limitations.”
But the court held that the FDA didn’t have the authority to take actions in 2016 and 2021 that expanded access to the drug. The appeals court essentially turned back the clock, limiting mifepristone’s use to the first seven weeks of pregnancy, as well as barring telehealth visits and mail delivery of the pill. Those restrictions are on hold while the Supreme Court considers the case.
Last year the Fifth Circuit court justified prohibiting mail delivery of mifepristone by citing the Comstock Act, a 19th-century law that makes it a federal crime to mail any “article or thing designed ... or intended for producing abortion.” Although the Comstock Act has been weakened over time, it is still on the books.
No one knows how the Supreme Court will interpret the Comstock Act because it hasn’t been enforced in decades, says David S. Cohen, a professor at Drexel University’s Thomas R. Kline School of Law.
Some conservative groups have interpreted the law to include not just medications but also any equipment or medical supplies used in abortions, Ziegler says.
“[These groups] argue that the Comstock Act bars the mailing of any abortion-related item,” Ziegler says. “But they also claim that every abortion in the U.S. involves an item placed in the mail; no one makes their own drugs or scalpels, for example. For this reason, the antiabortion movement argues that the Comstock Act will function as a ban on all abortions: they argue it can be used against anyone performing any abortion because that procedure will involve something put in the mail.”
Allies of Donald Trump are promoting this interpretation of the law, although it remains to be seen if the Supreme Court will accept it. If it does, “that would mean that anybody performing an abortion in the U.S. would be committing a crime because they’re using something delivered by the mail,” Ziegler says. “Any abortion drug or device could be criminalized.”
If Trump is reelected, the Department of Justice could prosecute health providers or clinic employees for “mailing or using FedEx to ship anything that can produce an abortion,” Cohen says. “And then we would have to get it tested out in the courts, with criminal prosecutions hanging in the balance.”
Who Should Decide Whether Drugs Are Safe?
FDA scientists—including physicians, pharmacists and biostatisticians—spend months or even years evaluating thousands of pages of research before deciding whether to approve a new drug or device. Most of these scientists have devoted their career to evaluating medical evidence and are not political appointees.
In an e-mailed statement to Scientific American, the Alliance Defending Freedom (ADF), which represents the Alliance for Hippocratic Medicine in its lawsuit against the FDA, said federal agencies should be held accountable if they violate their duties. “The FDA violated its responsibility to keep women safe when it removed the necessary in-person doctor visits for women using abortion drugs,” wrote Erik Baptist, a senior counsel at ADF. “If the FDA does its job, it shouldn’t face other challenges.”
Leaders of the pharmaceutical industry disagree. Allowing the Fifth Circuit’s ruling to stand would have a “destabilizing” effect on drug research and development, according to a friend-of-the-court brief filed by dozens of industry executives, pharmaceutical companies and associations and investors in support of the FDA.
“Under the Fifth Circuit’s logic, any physician, whether or not they actually treat patients using the drug in question, can ask a judge to undermine patient access to any drug nationwide, based on nothing but disagreement with FDA’s scientific judgment,” the brief states. “It would chill crucial research and drug development, undermine the viability of investments in this important sector, and wreak havoc on drug development and approval generally—irreparably harming patients, providers, and the entire pharmaceutical industry.”