WASHINGTON – The National Right to Life Committee (NRLC) submitted formal comments to the U.S. Food and Drug Administration (FDA) strongly opposing three separate citizen petitions filed by abortion advocates and allied states that oppose any efforts to strengthen safety protocols and seek to remove the Risk Evaluation and Mitigation Strategy (REMS) safety requirements for the abortion drug mifepristone.

National Right to Life also called on the FDA to reverse its approval of mifepristone.

“Despite decades of evidence showing the dangers of mifepristone, abortion advocates are pushing to strip away even the minimal safeguards that remain,” said Carol Tobias, president of National Right to Life. “The REMS protocols exist because this drug can cause life-threatening complications—including hemorrhage, sepsis, and undiagnosed ectopic pregnancy—and eliminating these protections would be reckless and politically motivated.” 

Responding to petitions from the American College of Obstetricians and Gynecologists (ACOG) and allied medical groups, the abortion pill manufacturer GenBioPro, and the states of Massachusetts, California, New Jersey, and New York, NRLC warned that removing REMS protections would place women’s lives at increased risk and further compromise the FDA’s drug safety standards.

NRLC emphasized that the REMS program—requiring prescriber certification, informed consent forms, and screening for contraindications—is not an “undue burden” but necessary for a drug that can cause serious injury or death.

“Women deserve real medical care, not a pill in the mail and instructions to lie to emergency room staff if something goes wrong,” said Tobias. “We call on the FDA not only to reject these petitions but, at a minimum, to restore in-person dispensing, reinstate full adverse event reporting, and begin independent post-market studies to assess the true dangers of mifepristone.” 

Tobias continued, “National Right to Life asks the FDA to reverse its original approval of mifepristone, a dangerous drug that has never saved any lives and was irregularly approved under a provision that was meant to be used for serious life-threatening illnesses. By doing so, the FDA would ensure that lives are protected from a drug that kills unborn children and endangers women.”

NRLC’s comments cite:

• FDA data documenting at least 36 deaths and thousands of adverse events linked to mifepristone use.

• Peer-reviewed research showing significantly higher complication rates for chemical abortions compared to surgical abortions, including a Finnish study reporting surgical intervention rates of 5.9% for chemical abortions versus 1.8% for surgical procedures.

• A 2024 Ethics and Public Policy Center report finding an 11% serious adverse event rate in U.S. insurance claims data—far higher than the 0.5% often cited by abortion advocates.

• Known risks of ectopic pregnancy, which occurs in 1–2% of pregnancies and can be fatal if undiagnosed—especially in telehealth abortions without in-person screening.

• The elimination of mandatory adverse event reporting in 2016, which has masked the true extent of complications.

NRLC’s letter in response to the petition of ACOG, the Society for Family Planning, and the Society for Maternal-Fetal Medicine can be found here.

NRLC’s letter in response to the petition of GenBioPro can be found here.

NRLC’s letter in response to the petition of Massachusetts, California, New York, and New Jersey can be found here.

Founded in 1968, the National Right to Life Committee (NRLC), the federation of affiliates in each of the 50 states, is the nation’s oldest and largest grassroots pro-life organization. National Right to Life works through legislation and education to protect innocent human life from abortion, infanticide, assisted suicide and euthanasia.