Concerned Women for America (CWA) has been on the front lines of the fight against chemical abortion drugs for decades. In 2011, we sued the FDA over its approval of the abortifacient contraceptive pill “Ella.” In 2020, we urged the Biden Administration to reinstate commonsense safety regulations on Mifeprex. In 2023, we submitted a brief in a Supreme Court case challenging the FDA, and in 2024, we joined a coalition letter urging President Biden’s FDA to perform a safety review of the chemical abortion drug.
But the fight against the abortion drug has never mattered more than it does now. As brick-and-mortar abortion clinics are closing nationwide after the fall of Roe v. Wade, drug-induced abortions are on the rise—two-thirds of all abortions in the United States are induced by Mifeprex. Federal regulation of the chemical abortion drug is a top-line priority for the pro-life movement.
At the urging of Sen. Josh Hawley (R-Missouri), twenty state Attorneys General and six major medical associations, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) committed to reassess and review Mifeprex on September 16, 2025.
On September 30, 2025, however, Commissioner Marty Makary’s FDA issued an approval of Evita Solutions’ generic chemical abortion drug—the very same drug the agency just committed to review. Concerned Women for America (CWA) CEO and President, Penny Nance, immediately criticized the agency: “Our government should be rejecting drugs that kill unborn children and put women’s lives at risk, not approving them. We hope the FDA will reconsider its approval.” Just a day later, we joined a coalition letter demanding that Commissioner Makary rescind the approval.
Twenty-five years ago, the FDA made its first fatal mistake in approving Mifeprex, the name-brand chemical abortion drug, in a suspect decision that has left millions of babies dead and countless women harmed in its wake.
Since 2000, the FDA has largely abandoned any measure of safety and responsibility in regulating the drug. FDA guidance originally included stringent safety standards for the use and prescription of Mifeprex: a minimum of three in-person consultations with doctor, a maximum gestational age of seven weeks, in-office dispensation and consumption, mandatory in-office follow-ups, and mandatory reporting of adverse events. None of these standards remain—Biden’s FDA hacked away at the last of the FDA’s commonsense regulations, and Mifeprex is now available on demand to the general public without a doctor’s advice or notice.
While proponents of the abortion drug claim that the abortion drug is “safer than Tylenol,” science says otherwise—any drug with the stated purpose of killing an unborn baby is fundamentally unsafe. Besides always killing a child, the chemical abortion drug is proven to be a threat to women’s health and safety, too: 11% of women experience a serious adverse medical event—like severe hemorrhaging or sepsis—after consuming Mifeprex for a DIY abortion. Drug-induced abortions are the riskiest kind of abortion with a complication rate four times higher than surgical abortions. Women aren’t being informed of these risks.
Further, with the advent of telemedicine, “online health centers,” and anonymous online drug dispensaries like HeyJane.com, pregnant women and girls are not seeing doctors prior to taking the abortion pill. Without an ultrasound and adequate screening to rule out ectopic pregnancy and confirm gestational age, the abortion drug can be fatal.
Together, the FDA’s lax regulations on Mifeprex and anonymous chemical abortion drug websites pose a significant threat to public safety. Any individual is able to order Mifeprex without age verification, identity verification, or medical screening. Human traffickers have unequivocal, unchecked access to abortion drugs to cover up their crimes, abusive boyfriends and husbands are not detected by healthcare professionals, and minors order the drug without their parents’ knowledge or consent.
The FDA must reconsider its reckless approval of Evita Solutions’ generic chemical abortion drug—the drug is designed to violently kill unborn babies, and it has been proven to harm and hospitalize women at alarming rates. With last week’s alarming decision, Commissioner Makary’s FDA is perpetuating a deadly downward spiral, joining in the disgrace of former Presidents Clinton, Obama, and Biden.
