Reviewing the Safety of Mifepristone: FDA's Latest Actions and Controversies
The Health and Human Services Secretary has requested the Food and Drug Administration Commissioner to review the safety data of mifepristone, commonly known as the abortion pill. The FDA confirmed the review plans but did not provide details on the timing or scope of the review. Mifepristone, approved by the FDA in 2000, has undergone periodic safety reviews without new concerns emerging.
A report from the Ethics and Public Policy Center, funded by right-wing organizations, raised concerns about mifepristone's safety, claiming that it causes adverse events in 1 in 10 patients. However, experts argue that some of these events are normal during a medication abortion and should not be considered adverse. The report lacks transparency and a comparison group for verification.
The Supreme Court rejected a challenge in 2024 that aimed to restrict access to mifepristone, preserving its availability nationwide. The FDA's actions in 2016 and 2021 to relax rules for mifepristone's use were not addressed in the ruling. Despite being a target of abortion opponents, mifepristone has been used by over 5 million patients since its approval.
Medication abortions, including mifepristone, accounted for more than half of all abortions in the U.S. healthcare system in 2023. Some states have policies restricting access to mifepristone, with four states prohibiting the mailing of abortion pills to patients. The impact of the latest review on mifepristone's access remains uncertain.