Kennedy says FDA is reviewing safety of abortion pill mifepristone
The Food and Drug Administration is currently conducting a review of the safety of the abortion pill mifepristone, as confirmed by Health and Human Services Secretary Robert F. Kennedy Jr. in a recent letter to Republican state attorneys general. This review comes in response to criticism from conservatives and anti-abortion groups, particularly after the Biden administration expanded access to mifepristone in 2023 through telehealth and mail delivery. The majority of women who choose to terminate their pregnancies opt for medication abortions.
In July, Republican attorneys general had expressed their concerns to Kennedy about the drug, prompting him to request the FDA to review the Risk Evaluation and Mitigation Strategy of mifepristone. The FDA is now examining the latest data on the drug, including real-world outcomes and evidence regarding its safety and efficacy. A study by the Ethics and Public Policy Center (EPPC) highlighted potential dangers associated with offering mifepristone without adequate medical supervision, citing adverse events such as blood loss requiring transfusions.
The EPPC study reported that nearly 11% of women may experience serious adverse events following a mifepristone abortion, while other data sources suggest a much lower rate of less than 1 in 200. Despite the concerns raised by lawmakers like Sen. Josh Hawley and the EPPC study’s focus on applying moral traditions to public policy, advocates of access to the abortion pill maintain that mifepristone is safe. The American Civil Liberties Union emphasized the drug’s exceptional safety record, citing over 100 studies that support its use for both abortion and miscarriage care.
Mifepristone, approved by the FDA in 2000, is used to terminate pregnancies up to 10 weeks of gestation and has been utilized by more than 7.5 million women since its approval. While the safety review of mifepristone is ongoing, the FDA has not indicated a timeline for its completion. Depending on the findings of the review, access to mifepristone may be impacted, potentially leading to restrictions on telehealth or mail delivery of the drug, or limiting who can prescribe it.
As the debate over the safety and accessibility of mifepristone continues, both proponents and opponents of the drug are closely monitoring the FDA’s review process. The outcome of this review could have significant implications for women’s reproductive healthcare in the United States.
