The case centers on the accessibility of mifepristone, the only drug approved specifically for terminating pregnancies, and whether the government applied a lawful review process of the drug when it first came out.
The Supreme Court decided to hear the case after a lower court ruled in April to revoke the Food and Drug Administration’s (FDA) 23-year-old approval of mifepristone, a move that would restrict how the pill is delivered and distributed. The restrictions, if allowed to go into effect, include cutting off access to the pill through the mail, barring telemedicine prescriptions, and reinstating a seven-week limit on its use—even in states where abortion remains legal.
The outcome of the Supreme Court case, called FDA v. Alliance for Hippocratic Medicine, could have far-reaching implications for reproductive healthcare access and the legal landscape surrounding abortion rights in the U.S.. Medication abortion has become an increasingly common and safe method for terminating pregnancies; more than five million women in the U.S. have used mifepristone for abortions since its approval, and six in 10 abortions last year were performed through medication, up from 53% in 2020, new research from the Guttmacher Institute shows.
“The Supreme Court has the potential to radically restrict access to this pill,” says Mary Ziegler, a law professor at the University of California at Davis with an expertise in abortion. “It’s an extremely significant case in that it would affect states where abortion is legal and states where it’s not.”
Although dozens of countries have approved mifepristone for use, including the U.S., its safety has come under scrutiny after the fall of Roe v. Wade. The plaintiffs in the case—led by a group of anti-abortion doctors and organizations—argue that the FDA did not adequately study the safety risks of the drug before approving it for sale in 2000, claiming that doctors have had to treat patients who suffered from complications from mifepristone.
“Our doctor clients are witnessing firsthand the harms inflicted by the FDA’s reckless actions,” Erik Baptist, a lawyer with Alliance Defending Freedom, said at a press conference on Thursday flanked by Republican members of Congress. He pointed to the FDA’s label for mifepristone, which shows that roughly one in 25 women—around 0.04%—will end up in the emergency room after using it. “The FDA must be held accountable for violating its duty to protect women’s health.” The FDA has forcefully countered safety concerns about mifepristone, pointing to data documenting the drug’s efficacy and safety, terminating pregnancies successfully 99.6% of the time with a complication rate lower than Tylenol.
In addition to the safety claims, the plaintiffs are also asking the court to find that the FDA’s approval of mifepristone and subsequent modifications to allow mail delivery violated an 1873 anti-obscenity law known as the Comstock Act, which governs how the U.S. Postal Service handles the delivery of contraception and items considered “obscene.” They also claim the FDA acted beyond its authority by fast tracking the initial approval of mifepristone under a federal provision to expedite the approval of “new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.” The plaintiffs contend that the use of the provision was not proper because pregnancy is not an illness, while the government says the approval process for mifepristone was never actually expedited and that the preamble to the provision makes it clear that it was intended to be used for “conditions” as well as illnesses.
A ruling against the FDA, legal experts say, could invite ideological challenges to other approved medications, from contraception to COVID-19 vaccines. “It particularly concerns me that the Supreme Court is being asked to weigh in on the safety of mifepristone,” Ziegler says, “because the court isn’t institutionally the place we want reviewing safety data.”
While it’s unclear how the court will rule, its 6-3 conservative majority suggests they may be inclined to uphold certain restrictions on mifepristone. Justices Clarence Thomas and Samuel Alito, both appointed by Republican presidents, wrote in an April court order that they would not have granted the Biden Administration’s request for a stay of the lower court decision, with Alito claiming that the FDA used its discretion “to permit the distribution of mifepristone in a way that the regulations then in effect prohibited.”
If access to mifepristone is limited by the Supreme Court, abortion providers may rely on misoprostol, a separate drug that can terminate pregnancies but is somewhat less effective and more prone to cause side effects. Misoprostol is typically taken in combination with mifepristone in the first 10 weeks of pregnancy, although it’s only approved by the FDA for the combined use with mifepristone and on its own to treat ulcers.
A decision in the mifepristone case is expected by the end of June, coming in the middle of the 2024 election campaign as reproductive rights take center stage. The issue has become a rallying point for Democrats, and polls show that the Supreme Court’s decision to overturn the constitutional right to an abortion in 2022 was met with disapproval by a majority of Americans. Following that ruling, 14 states completely banned abortion—including medication abortion—and six states began requiring patients to see their physicians in person before getting prescriptions for abortion pills.
President Joe Biden, who has promised to restore abortion protections if Democrats win control of Congress, has defended access to mifepristone. “The Administration will continue to stand by FDA’s decades-old approval and regulation of the medication as well as FDA’s ability to review, approve, and regulate a wide range of prescription medications,” the White House said in a statement. “Efforts to impose outdated restrictions on mifepristone would limit access to this critical medication in every state in the country.”
