The U.S. Supreme Court announced it will hear a legal challenge to the FDA’s approval of mifepristone, one of two drugs used for medication abortions. The pill, which was approved more than 20 years ago, will remain available in states where abortion is legal while the case plays out.
It’ll be the first time the conservative-majority Court will weigh in on abortion since it overturned Roe v. Wade, and it could radically change access to abortion care nationwide as well as the FDA’s regulatory authority. Even before the Dobbs decision, medication abortion accounted for 54 percent of abortions in the U.S. Since then, abortion pills have been a powerful tool for people to safely end a pregnancy on their own at home in the 16 states that have banned or effectively banned abortion. This dynamic has made both opponents and supporters of abortion rights deeply invested in either cutting off or expanding access to the pills.
Anticipating the uncertainty created by legal challenges, several telehealth and traditional abortion providers announced earlier this year that they will switch to misoprostol-only abortions if mifepristone gets taken off the market. While misoprostol is the second drug in the medication-abortion regimen, it is also safe on its own to terminate a pregnancy, if less effective.
“Back in the pre-Roe era, abortion was all done via procedure, which meant that if you could control the gatekeepers — the providers — then you could stop abortion in your state or stop a lot of it,” said Greer Donley, an associate professor at the University of Pittsburgh School of Law. “But now pills travel across borders all the time. It makes abortion really hard to control.”
The Court has yet to announce a date for hearing oral arguments, though the case will likely be decided next summer. Below, everything you need to know about the legal challenge to mifepristone.
What’s happened in the case so far?
The Supreme Court is consolidating two legal challenges — FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine — in this case. Last year, the conservative Christian legal group Alliance Defending Freedom sued the FDA and the Department of Health and Human Services in federal court in Texas on behalf of a collective of anti-abortion activists. The suit sought to reverse the FDA’s approval of mifepristone for abortion care, which dates back to 2000.
The statute of limitations to sue the agency over approval of a new medication is six years, making the Alliance’s lawsuit 16 years too late. While the argument underpinning the lawsuit is that the FDA exceeded its regulatory authority and had to “disavow science” in the approval process, the opposite is true. A 2008 report by the Government Accountability Office found that the FDA properly used its authority in approving and having oversight over mifepristone. If anything, there is even more research now that supports medication abortion’s safety, said Nicole Huberfeld, a public-health-law expert and professor at Boston University.
“We could point to the opioid crisis and say that there might be reasons to reconsider how certain opioids have been approved over time because the evidence is that they are harmful in certain ways,” she said. “On the other hand, with mifepristone, the gathered evidence over time has been that it is even safer than initially understood and more effective for the purpose for which it is approved, i.e., it can be used for a longer period of time and still result in a safe abortion.”
Medication abortion is between 95 percent and 99 percent effective as well as extremely safe with less than 0.4 percent of patients experiencing serious complications that require hospitalization. In other words, taking Tylenol or Viagra is riskier than using abortion pills. Mifepristone, the first in the two-pill abortion regimen, helps end pregnancy by blocking the hormone progesterone, while misoprostol, the second pill, causes contractions that help expel the uterus’s contents. Misoprostol is approved for stomach ulcers but used off-label for a wide range of gynecological purposes, including inducing labor and miscarriage management.
“The way that it is being framed by the Alliance Defending Freedom, the Alliance for Hippocratic Medicine, and the other groups is that this is not a safe drug, but that is just untrue,” Huberfeld said of the plaintiffs’ argument. “Their position is that no abortion is morally safe or good because they are coming at this from a religious perspective. But that is different from the FDA’s task, which is to decide whether a drug is, based on scientific evidence, safe and efficacious for the purpose for which it is created.”
The lawsuit also argues that mailing abortion pills is illegal under a federal criminal statute that was originally part of the anti-obscenity Comstock Act, which dates back to 1873 — and which banned contraception well before women even won the right to vote. (The Department of Justice disagrees with the plaintiffs’ interpretation.) “It’s batshit crazy. Literally, if it had been presented in virtually any other courtroom, it would have been thrown out,” said Kirsten Moore, director of the EMAA Project, which seeks to expand access to medication abortion.
But in April, U.S. District Judge Matthew Kacsmaryk, a Texas-based, anti-abortion Trump appointee, sided with the plaintiffs in nearly all of their arguments. He ruled that the FDA’s original approval of mifepristone should be suspended, as well as more recent requirements the agency has implemented for the drug. “The Court does not second-guess FDA’s decision-making lightly,” he wrote. “But here, 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.” He also agreed with the plaintiffs’ claims that mailing medication abortion violates federal law.
Kacsmaryk has a track record of opposing LGBTQ+ rights, birth control, and abortion. In his decision, he parroted almost every argument from the plaintiffs, using anti-choice terms such as “chemical abortion” and “unborn human” as well as repeating long-debunked claims about mifepristone’s safety record.
The Biden administration and Danco Laboratories, a company that manufactures mifepristone, then appealed to the Supreme Court, arguing that the lower court rulings would severely limit access to the drug nationwide. In late April, the Supreme Court put that order on hold while the case was fully heard. The ruling didn’t explain why the Court paused Kacsmaryk’s order, but it did note that Justice Clarence Thomas would have denied that stay and that Justice Samuel Alito dissented.
Some legal experts have said the FDA can choose to enforce its discretion, meaning that if the Texas decision ultimately stood, it can decline to pursue action against the entities that market and dispense mifepristone. However, the White House said that doing so would establish “a dangerous precedent” and that the administration plans to fight the ruling in court instead.
In December, the Supreme Court decided to take up the case. The justices did not announce when the Court would hold oral arguments.
“The Supreme Court did the right thing by agreeing to review the erroneous ruling of the lower court that would drastically curtail access to medication abortion,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. “Now the question is whether the Court will do the right thing and reject the radical arguments of the Plaintiffs in what should be a clear cut case. The Court has never invalidated a long-standing FDA approval like they are being asked to do here.”
How have states reacted to the uncertainty?
Officials in several states where abortion remains legal have moved to bulk up on mifepristone and misoprostol as the lawsuit continues moving through the court system.
California governor Gavin Newsom announced the purchase of about 250,000 pills of misoprostol and said the state had negotiated the purchase of up to 2 million pills, while New York governor Kathy Hochul announced that the state had begun purchasing a five-year supply of misoprostol. Massachusetts has purchased a one-year supply of mifepristone, and governor Maura Healey issued an executive order to protect health-care providers and patients from criminal and civil liability. Washington State began stockpiling a four-year supply of mifepristone as well with lawmakers working to implement a measure that would allow health-care providers to distribute the drug. Officials in Maine and Maryland also announced they were also considering purchasing additional doses of mifepristone.
If the Supreme Court overturns the FDA’s approval, it would impact patients across the country regardless of whether abortion remains legal in their state. And while misoprostol alone can be used to safely and effectively terminate pregnancies, pulling mifepristone off the shelves means patients will again contend with fewer options.
“This case is serious for a lot of reasons,” Donley said. “It really proves the truth that, with Roe gone, no one’s safe.”
Additional reporting by Catherine Thompson. This story has been updated.
The Cut offers an online tool you can use to search by Zip Code for professional providers, including clinics, hospitals, and independent OB/GYNs, as well as for abortion funds, transportation options, and information for remote resources like receiving the abortion pill by mail. For legal guidance, contact Repro Legal Helpline at 844-868-2812 or the Abortion Defense Network.
