Topline
Abortion drug mifepristone will not have its government approvals rolled back, as the Supreme Court ruled unanimously in favor of the government Thursday in a case that sought to further restrict medication abortion—declining to further roll back abortion rights two years after the high court overturned Roe v. Wade.
Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in ... [+]
Key Facts
A coalition of right-wing medical groups challenged the Food and Drug Administration’s approval of abortion drug mifepristone—one of two drugs taken during a medication abortion—in federal court, with the FDA going to the Supreme Court after lower courts rolled back additional 2016 and 2021 approvals of the drug that made it available via telehealth.
The justices ruled those medical groups did not have standing to bring the case, leaving mifepristone’s current approvals intact.
The challengers “do not prescribe or use mifepristone” themselves and are instead trying to regulate the actions of others, which means they don’t have standing to bring the case, Justice Brett Kavanaugh wrote in the court’s opinion in the case.
The court rejected the conservative groups’ argument that they can sue because doctors behind the case could be asked to treat complications from medical abortions, or because the FDA “has ‘impaired’ their ‘ability to provide services and achieve their organizational missions.’”
If it had sided with the challengers, mifepristone would return to how it was regulated before 2016, only being able to be prescribed and taken in-person at a physician’s office and only available through the first seven weeks of pregnancy, rather than 10.
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What To Watch For
Kavanaugh noted in his opinion that while the anti-abortion challengers don’t have standing to sue in court, they could still “present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process.” The Washington Post reported before the opinion came out that this may also not be the end of the legal battle over mifepristone, as GOP-led states are likely to launch a new battle against the abortion drug in court. It remains to be seen whether the courts will rule those states—which the Post predicts will include Missouri, Kansas and Idaho—have standing to sue.
Big Number
63%. That’s the percentage of U.S. abortions in 2023 that were medication abortions, according to the pro-abortion rights Guttmacher Institute. Some 53% of abortions were medication abortions in 2020 by comparison. The overturning of Roe v. Wade has seen medication abortions rise dramatically as states banned abortion and clinics closed down.
Surprising Fact
Despite challengers’ claims to the contrary, a study published in February in Nature found medication abortion that’s prescribed using telehealth is equally as safe and effective as when pills are prescribed and taken in a clinical setting. Studies have consistently found medication abortion using mifepristone is broadly safe and effective at terminating a pregnancy.
Tangent
The mifepristone case garnered attention from the pharmaceutical industry beyond companies manufacturing abortion drugs, as executives have worried about what impact a ruling against the FDA could mean for other politically controversial drugs, including HIV medications, COVID-19 vaccines and gender-affirming treatments. More than 300 pharmaceutical investors, C-suite executives and companies including Pfizer and Biogen signed onto an amicus brief urging the court to side with the FDA, which warned a ruling against the government will “[cast]
a shadow of lasting uncertainty over every FDA approval” and “create chaos in the processes for drug development, approval, and modification.”Key Background
Mifepristone is one of two drugs taken during a medication abortion along with misoprostol, and the drug terminates a pregnancy while misoprostol induces contractions to expel the tissue. The drug was first approved by the FDA in 2000 and has been proven to be overwhelmingly safe and effective at terminating a pregnancy. Medication abortion and mifepristone have come under attack by the right since the Supreme Court overturned Roe v. Wade in June 2022, as sending abortion pills through the mail and prescribing them via telehealth has become a key way for people in states where the procedure is banned to still access abortion care. Wyoming became the first state to ban abortion pills in March 2023—though the law was blocked in court—and Louisiana lawmakers passed a law classifying abortion drugs as “controlled substances” in May. The Biden administration has sought to widen access to the drug in the wake of Roe being overturned, releasing a legal opinion stating that mailing pills to states with abortion bans is legal under federal law and allowing mifepristone to be dispensed through brick-and-mortar pharmacies. Medical groups first brought the lawsuit challenging mifepristone’s legality in federal court in Texas in November 2022, where Trump-appointed Judge Matthew Kacsmaryk first overturned mifepristone’s FDA approval entirely before a federal appeals court slightly walked his decision back—ruling mifepristone should not have its approval revoked entirely, and only its more recent approvals in 2016 and 2021 should be undone.
This story is breaking and will be updated.
