Health and Human Services Secretary Robert F. Kennedy Jr. revealed Wednesday that he has ordered the Food and Drug Administration (FDA) to conduct a “complete review” of a chemical abortion pill amid reports that the drug isn’t as safe as advertised.
“It’s alarming,” RFK Jr. said of a recent study conducted by the Ethics & Public Policy Center that found nearly 11% of women who used the popular abortion pill mifepristone experienced a “serious adverse event.”
“I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,” the HHS secretary revealed during a Senate Health, Labor, Education and Pensions Committee hearing.
The Ethics & Public Policy Center study – the “largest-known” on the abortion pill – analyzed insurance claims data from 865,727 prescribed mifepristone abortions between 2017 and 2023.
The study found 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.
Sen. Josh Hawley (R-Mo.) cited the group’s research as he questioned RFK Jr. during the hearing and noted that the study showed the rate of serious adverse health effects “is 22 times higher than the FDA’s current label” for mifepristone, “which says it’s just 0.5%.”
“Clearly [the study] indicates, at the very least, that the label should be changed,” Kennedy Jr. told Hawley.
Mifepristone was originally approved by the FDA in 2000.
The Ethics & Public Policy Center, which released its findings last month, argued that the FDA should implement “stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,” in light of its study.
“The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,” the group concluded.
The FDA initially OK’d mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama.
Former President Joe Biden opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year.
The Washington, DC-based Ethics and Public Policy Center is a conservative think tank and advocacy group that seeks “to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics, in pursuit of America’s continued civic and cultural renewal,” according to the group’s website.
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