A coalition of pro-life advocates, including Kelsey Reinhardt, president and CEO of CatholicVote, on Friday called on Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary to immediately reverse the FDA’s recent approval of a new generic version of the abortion drug mifepristone.
In a letter sent to the two officials, the coalition condemned the FDA’s decision as “reckless,” urging that mifepristone be withdrawn from the market entirely. The signers said the approval undermines Secretary Kennedy’s own public statements promising closer scrutiny of abortion-drug safety data.
The letter, signed by prominent pro-life leaders like Lila Rose, Kristan Hawkins, Ryan T. Anderson, Penny Nance, Jor-El Godsey and Tony Perkins among others; also includes the signature of Most Rev. Michael F. Burbidge, Bishop of Arlington, Princeton Professor Robert P. George and North Dakota state senator Janne Myrdal, among others.
“This decision should be immediately reversed, and mifepristone should be pulled from the market altogether,” the letter states. “Rather than pausing to examine the mounting evidence showing the harmful effects of mifepristone, the FDA has chosen to expand access to a drug that has already killed millions of preborn children and harmed countless women.”
Mifepristone, first approved in 2000 during the Clinton administration, is used with misoprostol in a two-step chemical abortion regimen. The drug blocks the hormone progesterone, causing the death of the unborn child, while misoprostol induces contractions to expel the remains.
The coalition cites a new Ethics and Public Policy Center (EPPC) study analyzing 865,727 chemical abortions from 2017 to 2023, which found serious complications—including hemorrhage, infection, and sepsis—in more than one in ten cases. According to the letter, that rate is “twenty-two times higher” than what the FDA’s outdated data suggests.
Following the EPPC study, attorneys general from 22 states urged the FDA to restore the stronger safety restrictions that existed before 2016 and to reconsider mifepristone’s approval altogether.
The signers argue that current labeling for the drug relies on “only ten clinical trials involving fewer than 31,000 women, some of which date back more than forty years,” and that the Biden administration’s telehealth and mail-order abortion policies have further endangered women by removing in-person medical oversight.
Citing recent criminal cases involving the illicit distribution of abortion pills, including a Texas case in which a woman was allegedly drugged by her partner with pills obtained online, the coalition called for “stronger safeguards and enforcement to protect innocent lives.”
“Mifepristone is not medicine. It is a lethal drug designed to end the lives of preborn children, and in doing so, it places women at serious risk,” the letter continues. “The FDA’s mission is to protect public health. The American people expect decisive action, not delay, when lives are at stake.”
The letter closes with an appeal for the administration to align its actions with Secretary Kennedy’s previous commitment before the Senate Finance Committee on Sept. 4, when he said his department would no longer “bury” safety data related to abortion drugs.
The coalition’s demand follows the FDA’s quiet approval last month of a generic mifepristone manufactured by **Evita Solutions LLC**, a company whose stated mission is to “normalize abortion” and make it “accessible to all.” That move expanded the abortion pill market amid ongoing court battles over the drug’s approval and safety standards.
“Every abortion is a violation of human rights, and every life lost is an irreplaceable son or daughter,” the letter concludes. “The federal government must stop enabling this violence under the false banner of ‘healthcare.’”
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