“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of an early pregnancy,” Makary wrote in a letter to Sen. Josh Hawley (R-Mo.).
“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with professional career scientists at the Agency who review this data.”
Hawley has repeatedly tried to pressure the Trump administration into reviewing mifepristone’s safety. In April, the senator urged Makary to review new data released on the abortion medication and to “restore critical safeguards” on its use.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also pushed for a review of the drug. A spokesperson for HHS told The Hill Kennedy recently urged Makary to review new data on the drug as well.
The new data Hawley referred to comes from a report released in April from the conservative think tank The Ethics and Public Policy Center.
In the study, the group claims that 11 percent of people who undergo medication abortions experience an “serious adverse event.” That percentage is 22 times larger than the rate that is currently listed on the drug’s FDA label.
Researchers have cast doubt on the study. One aspect of the study that has come under scrutiny is the source of its data. The study claims to have used more than 865,000 insurance claims from prescribed medication abortions to come up with its findings, but it does not share the source for those insurance claims.
The study also breaks down serious adverse events into categories including sepsis, infection and emergency room visit, even though an ER visit alone does not count as an adverse event under the FDA definition.
Most of the serious adverse events fall into a vague category of “other abortion-specific complications.”
