The U.S. Supreme Court has issued a five-day stay on restrictions for the abortion pill mifepristone, maintaining access to the drug while a legal battle ensues. The hold, announced on Friday by Justice Samuel Alito, lasts until Wednesday night and postpones lower-court rulings that would have further limited access to the medication. The Biden administration and a drug manufacturer had requested the Supreme Court’s intervention to ensure continued availability of mifepristone without the lower-court constraints.
Mifepristone, also known as RU-486, is one of two medications commonly used together for nonsurgical abortions, which are also known as medication abortions. As part of a medication abortion, a woman usually takes mifepristone first, which is designed to block the production of progesterone, the hormone needed for pregnancy to progress. The second drug, misoprostol, is then taken one to two days later to induce contractions that eliminate the uterine contents. Together, these drugs can terminate a pregnancy up to ten weeks.
The use of mifepristone for abortion was first approved in the United States in 2000. It’s both highly effective—roughly 95% of users experience a complete abortion without the need for surgical intervention—and safe, with a severe complication rate of less than 0.4%. Today, medication abortions account for nearly 40% of all abortions in the U.S.
Despite its proven safety and efficacy, access to mifepristone has been highly regulated in the United States since its introduction. The drug is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS), a regulatory program that imposes additional distribution and use restrictions. The REMS rules for mifepristone require that the drug be dispensed in a healthcare setting, such as a clinic, hospital, or a doctor’s office, and by a certified prescriber.
Critics argue that the REMS requirements are medically unnecessary and restrict access to abortion. Due to the ongoing COVID-19 pandemic and increased use of telemedicine, there have been calls for the FDA to temporarily waive the in-person dispensing requirement for mifepristone. In July 2020, a federal judge in Maryland issued a preliminary injunction suspending the in-person requirement for the duration of the pandemic, citing the potential risks associated with in-person visits during a public health crisis.
The Trump administration appealed the injunction, and in January 2021, the Supreme Court reinstated the requirement. However, the Biden administration changed course shortly after and encouraged the FDA to review the restrictions on mifepristone. In April 2021, the FDA suspended the in-person dispensing requirement for the duration of the pandemic, effectively allowing healthcare providers to prescribe mifepristone via telemedicine and mail the drug to patients.
While the FDA’s decision was widely seen as a victory for reproductive rights, several states have since enacted restrictions on medication abortions. In December 2021, the U.S. Court of Appeals for the Sixth Circuit upheld an Ohio law requiring that mifepristone and misoprostol be dispensed in person, directly contradicting the FDA’s suspension of the in-person requirement. The following month, the Eighth Circuit similarly ruled in favor of a Missouri law that imposed a 72-hour waiting period and in-person counseling before accessing medication abortion.
These lower-court rulings prompted the Biden administration and the drug manufacturer to seek the Supreme Court’s intervention on Friday. By granting a temporary stay, the high court has shielded mifepristone, at least for the time being, from further restrictions. The fate of mifepristone access in the United States now hangs in the balance as the legal fight continues.
As the battle over abortion rights continues in the U.S., it’s crucial to preserve access to safe, effective, and affordable reproductive healthcare options like mifepristone. Medication abortions are playing an increasingly significant role in reproductive health, and timely access to mifepristone is essential for many women seeking to exercise their constitutional right to terminate a pregnancy. The Supreme Court’s decision to temporarily maintain access to the drug underscores the importance of continuing the fight for reproductive justice at all levels of government.
