Dozens of U.S. Senators are calling upon The U.S. Food and Drug Administration (FDA) to rescind its recent approval of a second generic version of the controversial chemical abortion drug, Mifepristone, to be manufactured by Evita Solutions, a telehealth company whose purported mission is to “normalize abortion” and make it “accessible to all.”The FDA approved the drug the day before the government shutdown began. In a letter to Evita Solutions, the FDA wrote: “We have determined your Mifepristone Tablets, 200 mg to be bioequivalent and therapeutically equivalent to the reference listed drug Mifeprex (mifepristone) tablets, 200 mg, of Danco Laboratories.”
On its website, Evita Solutions states: “Medical abortion care is rife with medically unnecessary restrictions and social stigma in the United States. As a result, many people who choose to end a pregnancy may struggle to get the necessary care they need. Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live. We know that you can make the best choice for your body.”
This is the second time the FDA approved a generic version of Mifeprex. It did so in 2019 when it approved the GenBioPro version, making this the second generic abortion pill approved during the Trump administration.
The approval of yet another generic version of such a controversial drug sparked outrage from pro-life members of congress, especially in light of recent studies that found nearly 11 percent of women are harmed after just one dose of Mifepristone. The drug is so dangerous that it comes risks for heavy bleeding, infection, and incomplete abortion which may require surgical intervention.
In response, 51 U.S. Senators sent a letter to HHS Secretary Robert F. Kenney, Jr. and FDA Commissioner Martin A. Makary, MD, to ask for the approval of the new drug to be rescinded.
“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 letter states. “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 letter goes on to remind the FDA of its recent statements “acknowledging the data discrepancies surrounding abortion pill safety and your commitment to reviewing the science. . . Given this commitment, however, we are deeply concerned about the FDA’s approval of a new generic version of mifepristone.”
The senators continued: “While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized. Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”
Pro-life leaders across the country have also voiced their opposition to the approval of this new drug.
Kristan Hawkins, president of Students for Life of America and Students for Life Action, decried the decision, calling it “a stain on the Trump Presidency and another sign that the deep state at the FDA must go.”
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser commended the Senators for urging the FDA to act swiftly to protect women an unborn children by restoring the abortion pill safeguards that were so recklessly removed by the Biden Administration.
“At a minimum the FDA must immediately reverse the Biden-era policy of removing doctors by allowing mail-order abortion drugs without in-person medical oversight,” Dannenfelser said in a statement. “Week after week these dangerous drugs cause more tragedies: women coerced and poisoned, girls rushed to the ER, mothers dying along with their babies – all while the abortion industry profits from deception and abusers benefit from unfettered drug access. Enough is enough.”
She called upon the government to immediately reinstate the commonsense safeguards that were in place during President Trump’s first term while a comprehensive study of these dangerous drugs is conducted.
“Every day they wait, more unborn Americans die and more women and girls go to the ER with serious complications.”
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