Fifty-one Republican senators sent a letter to Health Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary on Thursday urging them to reevaluate the FDA’s decision to approve a new generic version of the abortion pill.
Last week, the FDA approved a new generic version of mifepristone – the first drug used in a two-drug medication abortion regimen — as the agency, under the direction of the Department of Health and Human Services (HHS), performs a safety review of the drug following a shocking study suggesting a much higher complication rate than previously reported. In response to conservative and pro-life backlash, the HHS previously told Breitbart News it “must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.”
Senators, led by Sen. Lindsey Graham (R-SC), asked the FDA to reverse course as the safety review continues and requested the agency reinstate mifepristone safeguards rolled back by the pro-abortion Biden administration.
“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. “We applaud your acknowledgment of the concerns surrounding the FDA’s approval and regulation of the abortion pill regimen – mifepristone and misoprostol – and your commitment to following the science to ensure the safety and well-being of women and unborn children alike. 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,” the lawmakers continued. “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.”
Lawmakers specifically urged the the agencies to suspend approvals of other generic version of abortion drugs during the safety review, include generic forms of mifepristone in the review, reinstate in-person dispensing requirements for mifepristone, and revoke FDA guidance allowing pharmacies to distribute the drug.
“Unrestricted access to abortion pills is systematically undermining states’ rights and violating pro-life state laws,” the senators wrote. “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.”
“…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,” they said.
The FDA specifically approved a generic form of the abortion pill produced by Evita Solutions LLC, a company that says its mission is to “normalize abortion” and make it “accessible to all.” In the FDA’s letter to Evita Solutions LLC, the agency said it concluded the drug is “bioequivalent and therapeutically equivalent” to the brand name mifepristone drug Mifeprex, which is made by Danco Laboratories, and has therefore met the requirements for approval.
RELATED: Exclusive — Shocking Data Suggests Abortion Pill Complications 22 Times Higher Than Previously Reported: ‘FDA Must Reinstate Stronger Safeguards’
In 2023, medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system — meaning an estimated 642,700 unborn babies died in medication abortions, according to the pro-abortion Guttmacher Institute. The percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
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