National Right to Life Statement

on FDA Approval of a New Generic Mifepristone

WASHINGTON — On Tuesday, the U.S. Food and Drug Administration, following regulatory law, approved a new drug application for another generic version of the abortion drug mifepristone.

Under the Hatch-Waxman Act, the U.S. Food and Drug Administration is legally required to approve a generic drug application (ANDA) if it meets all statutory and regulatory requirements.

“We must confront the reality of chemical abortion drugs,” said Carol Tobias, president of National Right to Life. “While the law compels FDA approval of generics when requirements are met, the agency has a duty to safeguard public health through rigorous review and honest reporting.”

According to recent data, over a period of more than a decade, the FDA received thousands of reports of serious side effects, including severe blood loss requiring emergency transfusions. A review launched by the Department of Health and Human Services under Secretary Robert F. Kennedy, Jr. and Commissioner Dr. Marty Makary is now underway to determine whether the existing regulatory framework for mifepristone is adequate.

“Mifepristone is the only drug on the market that was created to take lives,” said Tobias. “Lives are at stake—not only the lives of the unborn children these drugs are designed to end, but also the women placed at risk by incomplete data and inadequate oversight.”

NRLC recently released a white paper, “Why Abortion Pill Complications Are Underreported” (September 2025), which highlights significant gaps in oversight and reporting. The paper reveals how adverse events such as hemorrhage, infection, and incomplete abortions often go unrecorded in official data, giving the public a misleading picture of safety.

The white paper can be accessed here.