Health and Human Services Secretary Robert F. Kennedy Jr. said he has directed the FDA to conduct a review of the abortion pill.
The statement came after Senator Josh Hawley (R-MO) asked Kennedy about mifepristone, discussing a recent study that found nearly 11% of women have an adverse effect from the pill.
“You have said you will do a top-to-bottom review,” Hawley said. “Do you continue to stand by that, and don’t you think that this new data shows the need to do a review is in fact very pressing?”
“It’s alarming,” Kennedy responded. “Clearly, it indicates that at the very least, the label should be changed. I’ve asked Marty Makary, who is the director of the FDA, to do a complete review and to report back.”
The think tank behind the study, the Ethics and Public Policy Center, described it as the “largest-known study of the abortion pill,” and found that “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.” It explained that the “real-world” rate of the serious adverse events is “at least 22 times as high as the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label.”
The group urged the FDA to “immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone” and investigate the harms caused by the abortion pill.
The group explained that the pill’s manufacturer and the FDA base their data on the “results of 10 clinical trials with a total of 30,966 participants, less than 0.5 percent of whom reportedly experienced serious adverse reactions.” For the study, however, the think tank “analyzed real-world insurance claims data for 865,727 prescribed mifepristone abortions,” finding that the nearly 11% adverse event rate is far higher than the summary reported on the drug label.
