Abortion Pill Mifepristone: History, Safety, and the U.S. Supreme Court Legal Battle
Medication abortion is also known as abortion with pills or medical abortion. Mifepristone and misoprostol are used in a two-drug regimen for medication abortions. Mifepristone, manufactured by Danco, is the first pill in a two-step process; it blocks the effects of the hormones necessary to maintain a pregnancy, while misoprostol causes the uterus to contract, expelling the pregnancy. In the United States, medication abortions comprised 63% of all abortions in the nation in 2023, up 10% from 2020.
The History of FDA Approval and Access
Mifeprex, the patented version of mifepristone, was originally approved by the FDA in 2000. At that time, it could be taken up until seven weeks of pregnancy. Over the years, the FDA has updated the conditions on the use of the drug to expand access. In 2016, the FDA approved the drug for patients up to 10 weeks of pregnancy. By 2019, mifepristone, the generic of Mifeprex, was approved by the FDA. During 2020, because of the COVID-19 pandemic, mifepristone was approved to be dispensed by mail via telehealth. A year later, the FDA approved the sale of the drug in certified pharmacies.
| Year | Regulatory Milestone |
|---|---|
| 2000 | FDA approval of Mifeprex (up to 7 weeks pregnancy) |
| 2016 | FDA approved use for patients up to 10 weeks of pregnancy |
| 2019 | Generic mifepristone approved by the FDA |
| 2020 | Approval for dispensing by mail via telehealth |
| 2021 | FDA approved sale in certified pharmacies |
| 2024 | Supreme Court unanimously preserves access |
Safety and Clinical Effectiveness
Mifepristone has been determined to be safe in numerous scientific studies and has been used by over 5 million patients in the U.S. Reproductive rights leaders, such as Mini Timmaraju, the president and CEO of Reproductive Freedom for All, stated that "Mifepristone is safer than Tylenol." The medication is endorsed by several organizations, including the American College of Obstetricians & Gynecologists and the American Medical Association. The Food and Drug Administration has approved medication abortion for up to 10 weeks of pregnancy and the World Health Organization authorizes its use for up to 12 weeks.
Legal Challenges and Supreme Court Rulings
In April 2023, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a decision that suspended the FDA’s 23-year-old approval of mifepristone. The U.S. Department of Justice appealed the decision to the U.S. Court of Appeals for the 5th Circuit. This case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, became a legal challenge to the FDA’s studies and approval of the drug.
The Biden administration went to the Supreme Court immediately, asking the justices to keep Kacsmaryk’s order entirely on hold to preserve the status quo. U.S. Solicitor General Elizabeth Prelogar argued that lower court orders "countermand[ed] FDA’s scientific judgment and unleash[ed] regulatory chaos." On June 13, 2024, the Supreme Court justices in a unanimous decision preserved access to mifepristone, writing that “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
Impact on Reproductive Healthcare
Following oral arguments, reproductive rights leaders said the lawsuit was just another attempt by anti-abortion groups to end access to abortion care. Evan Masingill, the CEO of GenBioPro, noted that a ruling against the FDA could stifle pharmaceutical innovations and put the status of other approved drugs at risk. While the Supreme Court decision preserved access, abortion remains banned or severely restricted in 21 U.S. states. The order means that the drug will remain widely available while litigation continues in the lower courts.