Appeals Court Upholds FDA Approval of Mifepristone for Abortion, but Allows Restrictions to Remain
In a highly anticipated decision, the U.S. Court of Appeals for the Fourth Circuit has upheld the Food and Drug Administration’s (FDA) approval of mifepristone, a medication used to terminate early pregnancies, but has allowed certain restrictions to remain in place.
Mifepristone, also known as the abortion pill or RU-486, was approved by the FDA in 2000 for use up to 70 days after the start of a woman’s last menstrual period. The medication works by blocking the hormone progesterone, which is necessary for the pregnancy to continue. It is typically used in combination with another drug, misoprostol, which causes the uterus to contract and expel the pregnancy.
However, the use of mifepristone has been subject to controversy and legal challenges for years. In 2020, a federal district court in Maryland issued an injunction against the FDA’s requirement that patients receive the medication in-person at a medical facility, ruling that the restriction imposed a substantial obstacle to women seeking abortions and put them at risk of COVID-19 exposure.
The FDA appealed the decision, arguing that the restriction was necessary to ensure the safe use of the medication and to prevent fraud and abuse. In a 2-1 decision, the Fourth Circuit agreed with the FDA and lifted the injunction, allowing the in-person requirement to remain in place.
However, the court also struck down a requirement that the medication be dispensed only by certified healthcare providers who have completed a training program. The majority of the court found that this requirement was not supported by evidence and created an undue burden on women seeking abortions, particularly in rural areas where healthcare providers may not be readily available.
The decision was welcomed by reproductive rights advocates, who have long argued that the FDA’s restrictions on mifepristone were medically unnecessary and politically motivated. “Today’s decision affirms what we have always known: that the FDA’s restrictions on medication abortion are medically unnecessary and politically motivated,” said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement.
However, anti-abortion groups criticized the decision, arguing that the in-person requirement was necessary to protect women’s health and safety. “The decision by the Fourth Circuit Court of Appeals to strike down critical FDA regulations of the abortion pill, including the in-person dispensing requirement, is deeply troubling and undermines the FDA’s responsibility to ensure the safety and efficacy of drugs,” said Susan B. Anthony List President Marjorie Dannenfelser in a statement.
The decision is expected to have implications for similar legal challenges to mifepristone restrictions in other states. It also comes amid a broader push by anti-abortion groups and lawmakers to restrict access to abortion at the state and federal levels.
