Overview

• Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told 22 Republican attorneys general in a Sept. 19 letter that the agency will conduct its own evaluation of mifepristone’s safety and efficacy.
• Abortion-rights groups warn the process could lead to new federal limits that reduce access to medication abortion, which has expanded through telehealth and mail and now accounts for a majority of U.S. abortions.
• FDA data indicate the drug has a very low mortality rate of about five deaths per million users since 2000 and is authorized for use through 10 weeks’ gestation.
• A recent conservative Center for Ethics and Public Policy study claiming nearly 11% serious adverse events conflicts with roughly 0.5% rates reported in FDA-reviewed clinical studies and is a central point of dispute.
• Kennedy told senators the FDA is collecting new data and accused the previous administration of misrepresenting safety information, and regulators have not announced any rule changes.