Republican senators are calling on one of the nation’s most influential health agencies to reconsider its recent decision to expand access to abortion drugs. The U.S. Food and Drug Administration (FDA) decided late last month to quietly approve production of a generic version of the abortion drug mifepristone, despite having previously pledged to conduct a thorough review of the pill’s safety. On Thursday, a coalition of 51 GOP senators issued a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, urging the officials to suspend approval of the generic abortion drug expansion and reinstate safeguards on mifepristone’s prescription and use that were previously removed while the FDA conducts its abortion drug review.
“Under your leadership, we have seen a strong commitment to reevaluating the policies that affect the most vulnerable among us — the unborn,” the senators wrote, referring to Makary’s promise to conduct a mifepristone review. “But the work is far from over. The ‘abortion-on-demand’ culture enabled by the Biden-Harris administration’s removal of critical safeguards on the only FDA-approved abortion regimen is currently the biggest threat to unborn life in America today.”
When mifepristone was first approved by the FDA in 2000, the agency placed numerous restrictions around the drug’s prescription and use: three in-person physician visits were required before the drug could be prescribed, the drug could only be prescribed by a physician, it had to be dispensed and consumed in the physician’s office, and a follow-up visit was required, as was reporting of any complications. In 2016, then-President Barack Obama eliminated the requirement that the abortion drug be prescribed by a physician and consumed in-office, as well as the mandatory follow-up visit and reporting of complications, and lowered the number of in-person physician visits prerequisite to prescription. Under then-President Joe Biden in 2023, the FDA did away with most of the remaining safeguards, requiring no in-person physician visits, no physician to prescribe the drug, no dispensing or consuming the drug in-office, no follow-up visit, and no reporting of complications.
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“Under current FDA regulations, these drugs can be obtained via mail order without meaningful consultation with a medical professional and without any confirmation of who is purchasing them or for what purpose. These policies have enabled abortion pills to be obtained by abusers, traffickers, and even minors,” the senators wrote. “Unrestricted access to abortion pills is systematically undermining states’ rights and violating pro-life state laws. Every month, thousands of abortion drugs are shipped into states that have otherwise limited access to abortion after Dobbs, degrading pro-life laws at the state level across the country,” they continued. “Pro-life states have been forced to defend their citizens against radical abortion extremists. Louisiana and Texas are taking legal action against a New York doctor whose mail-order abortion business put at least two women in the hospital and a California doctor who allegedly sold abortion drugs to men.”
The GOP lawmakers noted how dangerous the abortion drug is even when used legally and as intended, citing numerous studies on adverse complications and emergency room visits. “The Biden-Harris administration enabled the deception of American women and the violation of states’ constitutional rights by relying on faulty data to claim that there would be no increase in complications if abortion drugs were approved for mail-order,” the senators wrote. “We commend your recent statements acknowledging the data discrepancies surrounding abortion pill safety and your commitment to reviewing the science.”
“Today, your agencies have all the information they need to bring an end to previous Democrat administrations’ abortion drug regulations while a comprehensive review is conducted,” the Republican coalition asserted. They urged Kennedy and Makary to suspend the approval of generic brands of mifepristone for the duration of the FDA’s safety review, include generic versions of mifepristone in that safety review, reinstate the in-person dispensing requirement for all versions and brands of mifepristone, suspend “the distribution of mifepristone and all generic versions as an ‘imminent hazard’ under Section 505(e) of the Federal Food, Drug, and Cosmetic Act (FDCA),” and withdraw “FDA guidance permitting pharmacy distribution of mifepristone and all its generic versions.” The senators concluded, “We are committed to continuing to work together to give a voice to the voiceless and protect women from the dangerous effects of unregulated access to chemical abortion drugs. The life, safety, freedom, and health of millions of Americans, born and unborn, depend on it.”
Only Senators Lisa Murkowski (R-Alaska) and Susan Collins (R-Maine) refused to join their Republican colleagues in demanding more scrutiny.
In comments to The Washington Stand, Mary Szoch, director of the Center for Human Dignity at Family Research Council, said, “Republican senators have recognized that mifepristone poses a huge threat to women. I applaud their call to suspend the distribution of this dangerous drug and all of its generic forms. Mifepristone causes serious complications in more than one in 10 women.” She continued, “Even when it doesn’t cause bodily harm, it shatters the hearts of mothers who see their visibly recognizable unborn child — a person abortionists promised was just a clump of cells — delivered into the toilet. It takes a life and leaves women alone to deal with the excruciating physical and mental pain of abortion.” Szoch added, “This drug should not be on the market, and I am so grateful that Republicans are fighting for its removal.”
Joy Stockbauer, policy analyst at FRC’s Center for Human Dignity, told TWS, “One important point that these pro-life senators accurately identify in their letter is that the Biden administration, and the Obama administration before it, bear the blame for eliminating common sense safeguards that previously helped mitigate the dangers women experienced from the abortion pill.” She explained, “Former President Biden is to blame for current policies that violate pro-life laws across the states and enable abusers to prey on women and their unborn children. However, every day that the current FDA does not decisively act to reevaluate the proven dangers of this notorious drug and reinforce bare minimum safety standards for women is a day wasted.”
Stockbauer concluded, “I concur with these pro-life senators in urging the FDA to act immediately to protect women and babies from the abortion industry’s drug problem.”
