(Oregon Right to Life) — The U.S. Department of Health and Human Services (HHS) last week sent a letter to nearly two dozen state attorneys general acknowledging the reported dangers of the abortion pill mifepristone and affirming they are actively reviewing adverse events.
In the September 19 letter obtained by The Gateway Pundit, HHS Secretary Robert F. Kennedy Jr. and U.S. Food and Drug Administration (FDA) chief Dr. Marty Makary pledged to “ensure that women’s health is properly protected by investigating the circumstances under which mifepristone can be safely dispensed.” The first drug in the abortion pill regimen, mifepristone blocks the action of the growth hormone progesterone, causing the embryo to die of starvation.
“HHS is committed to studying the adverse consequences reported in relation to mifepristone to ensure the [Risk Evaluation and Mitigation Strategies] are sufficient to protect women from unstated risks,” Kennedy and Makary wrote in the letter, addressed to the twenty-two attorneys general who wrote to the FDA in July to urge them to restore regulations on the drug.
“HHS—through the FDA—is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” they said.
Kennedy and Makary acknowledged the potential dangers of mifepristone flagged by the attorneys general in their letter, adding that 2,740 adverse events associated with the drug have been recorded by the FDA itself between 2000 and 2012 even as “safeguards for women regarding the administration of mifepristone have significantly reduced.”
“The concerns you have raised in your letter merit close examination,” they wrote. “This Administration will ensure that women’s health is properly protected by investigating the circumstances under which mifepristone can be safely dispensed.”
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Abortion pills have become the most popular method of abortion in the U.S., reportedly accounting for an estimated 63% of legal abortions in 2023.
The increased use of the drugs, systematic loosening of federal regulations over the past decade (including the FDA’s 2016 removal of the requirement to report complications that do not result in death), combined with the drugs’ risk of causing serious adverse reactions, have prompted widespread concern among pro-life advocates both for women’s health and safety as well as protections for the unborn.
Concluding their letter, Kennedy and Makary vowed that HHS and FDA will “remain committed to protecting the health and safety of pregnant women” and “ensure that the FDA’s decisions are grounded in Gold Standard Science and rigorous, transparent, and objective evidence.”
The September 19 letter comes after Kennedy briefly affirmed in a Senate hearing earlier this month that the HHS review was underway.
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The HHS and FDA review has been prompted by a story released by the Ethics and Public Policy Center (EPPC), which found a far higher adverse reaction rate associated with mifepristone than previously reported.
The study, based on an analysis of public and private insurance claims submitted by 330 million U.S. patients from 2017 to 2023, calculated the severe complication rate associated with the drug to be twenty-two times the one currently listed on the drug’s official FDA label. According to the research, 10.93% of the 865,727 women prescribed mifepristone for abortions over the seven-year period suffered a serious adverse event within 45 days of taking the drug. That percentage dwarfs the less than 0.5% rate of severe adverse events listed on the current FDA label for the two-drug mifepristone and misoprostol regimen.
EPPC researchers urged federal officials to take the data seriously and restore regulations.
