The Supreme Court has ruled that mifepristone, one of two pills used in medication abortion, will remain broadly available in states where abortion is legal as long as the battle over its FDA approval is playing out in the courts — which could take months.
The decision late on Friday followed several chaotic weeks when the availability of the drug hung in the balance. Earlier this month, U.S. district judge Matthew Kacsmaryk, a Texas-based, anti-abortion Trump appointee, suspended the FDA’s 23-year-old approval of mifepristone. An appeals court later paused part of that order, allowing the reinstatement of several restrictions on the drug that had been lifted in 2016 — including those blocking mifepristone from being sent to patients through the mail and reducing its approval for use at seven weeks of pregnancy rather than ten.
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. The latest decision wasn’t signed and 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.
Even before the end of Roe, medication abortions accounted for 54 percent of abortions in the U.S., and since the Supreme Court’s Dobbs decision, abortion pills have been a powerful tool for patients to safely end a pregnancy on their own at home in the 14 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, triggering a wave of legal challenges.
Anticipating the uncertainty created by the case before Kacsmaryk, several telehealth and traditional abortion providers announced they would switch to misoprostol-only abortions if mifepristone were taken off the market. While misoprostol is the second drug in the medication-abortion regimen, it is safe, if less effective, on its own to terminate a pregnancy.
For the time being, however, mifepristone will remain available in states where abortion is legal.
“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 Texas judge sided with anti-abortion activists’ arguments.
In late November, 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 lawsuit 16 years too late. While the argument underpinning it is that the FDA exceeded its regulatory authority and had to “disavow science” in the approval process, the opposite is actually true. A 2008 report by the Government Accountability Office found the FDA had 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 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 these abortion pills. Mifepristone, the first in the two-pill abortion regimen, helps end a 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 is used off label for a wide range of gynecological purposes, including inducing labor and miscarriage management.
“The way 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 banned contraception well before women even had 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 Kacsmaryk sided with the plaintiffs in nearly all of their arguments. He ruled that the FDA’s original approval of mifepristone should be suspended, along with 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 pills for 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.
“It’s hard to overstate the impact of today’s callous decision to ban one of the most important and common methods of abortion care,” said Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco. “This medicine has gone through the toughest safety reviews and has been used safely and effectively for over 20 years. We need expanded access to abortion care, not court rulings based in junk science.”
The Supreme Court has preserved access to mifepristone for now.
The Fifth Circuit Court of Appeals had previously paused part of Kacsmaryk’s order on the grounds that too much time had passed since the FDA first approved mifepristone and that it needed time to hear the case on its merits. But the judges allowed restrictions on the drug that the FDA had lifted in 2016 to be implemented once again, saying the DOJ had failed to demonstrate that easing those regulations was “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for 16 years following the 2000 Approval.”
The Supreme Court put that order on hold while the case is fully heard by the lower courts.
Some legal experts have said the FDA can choose to enforce its discretion, meaning that if the Texas decision ultimately stands, 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.
Several other legal challenges around abortion pills are playing out. In a separate case, a group of Democratic state attorneys general sued in the Eastern Court of Washington to expand access to mifepristone by eliminating what it describes as “unnecessary” and “burdensome” restrictions the FDA has placed on the drug. Minutes after Kacsmaryk issued his opinion, U.S. district judge Thomas O. Rice issued a competing decision to prohibit the FDA from pulling mifepristone off the market in the 17 states, plus the District of Columbia, that constitute the plaintiffs in that lawsuit. (The states are Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.)
The Justice Department asked the Washington court for clarification on its ruling. It’s unclear how the conflicting orders on mifepristone impact two other cases, filed in North Carolina and West Virginia, that also seek to dramatically expand access to the pills.
A fourth lawsuit was filed Wednesday in the U.S. District Court of Maryland by GenBioPro, which makes a generic version of mifepristone. The company sued the FDA, claiming the agency had denied it due process in responding to the court orders halting mifepristone’s approval. The plaintiff also said the back-and-forth in the courts, as well as the lack of reassurance from the FDA, has “left GenBioPro at risk of severe civil and criminal penalties if it does not cease shipments of mifepristone.”
More than 400 executives from drug and biotech companies, none of which make mifepristone, issued an open letter condemning Kacsmaryk’s decision. They raised concerns that the decision undermines the FDA’s authority and puts “an entire industry focused on medical innovation at risk.” The signatories included executives from Pfizer, Biogen, and Merck.
“Judicial activism won’t stop here,” the statement reads. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
States are stockpiling mifepristone and misoprostol.
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 misoprostol pills and said the state had negotiated the purchase of up to 2 million, 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. 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 announced they were also considering purchasing additional doses of mifepristone.
If the Texas ruling stands, 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 have to 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.