National Right to Life disputes pro-abortion group’s claim that recent mifepristone ruling is a ‘win for science’

National Right to Life challenged a pro-abortion group’s characterization of a recent federal court ruling on mifepristone as a “win for science,” arguing that the decision identified problems with the Food and Drug Administration’s (FDA) decision-making process but did not establish that those safeguards serve no medical purpose. 

U.S. District Judge Robert Ballou ruled July 23 in Whole Woman’s Health Alliance v. FDA that the FDA failed to adequately justify certain safety requirements governing mifepristone under its 2023 Risk Evaluation and Mitigation Strategy program. Ballou found that the agency failed to consider relevant evidence, analyze the requirements under applicable statutory factors, and reasonably explain its decision to retain them.

The requirements include special certification for prescribers and pharmacies and a patient agreement form acknowledging information about the drug and its risks. The plaintiffs in the lawsuit — abortion providers in Virginia, Montana, and Kansas — argued that the remaining restrictions burden access to mifepristone without providing medical benefits.

Ballou ordered the FDA to reconsider the restrictions but did not immediately eliminate them.

In a July 24 statement, the Center for Reproductive Rights, which brought the lawsuit on behalf of abortion providers, called the ruling a “win for science” and said the court found the requirements “unjustified and baseless.”

National Right to Life Director of Outreach and Events Rai Rojas argued in a July 27 statement that the group’s response overstated what the court decided.

“In plain English, the court told the FDA to explain itself more fully,” Rojas said. “That is far different from proving that the restrictions lack a medical purpose.”

Rojas characterized the decision as a procedural setback for the pro-life movement but argued that it did not settle the broader dispute over mifepristone’s safety.

“Judge Ballou ordered the agency to provide better explanations,” he said. “He did not prove that mifepristone is harmless, that existing safeguards lack value, or that opposition to chemical abortion rests on politics rather than evidence.”

Mifepristone, approved by the FDA in 2000 and used in combination with misoprostol, is the first drug in a two-drug abortion regimen. While the FDA has labeled the drug “safe and effective,” pro-lifers have long raised concerns about its severe risks to women.

“The FDA’s statement that mifepristone is ‘safe and effective’ under approved conditions does not prove that every safeguard is unnecessary,” Rojas said. “Federal regulators routinely impose special controls on drugs with known serious risks. A drug can meet the FDA’s approval standard while still requiring careful prescribing, monitoring, and reporting.”

Rojas cited several of mifepristone’s documented risks, including hemorrhage, infection, incomplete abortions, and the need for emergency surgery. He also referenced FDA post-marketing reports of deaths linked to sepsis and ectopic pregnancy complications, while noting challenges in full reporting of nonfatal adverse events. 

“Incomplete abortions are particularly concerning,” Rojas said. “Some women require additional medication or surgery after the regimen fails to remove all pregnancy tissue. Mail-order distribution and telemedicine can make it harder to confirm gestational age, diagnose ectopic pregnancy, or ensure that women receive timely follow-up care.”

He also cited an Ontario study published in 2023 that found 10.3% of women who underwent chemical abortions sought emergency care within six weeks. 

Rojas said the “full extent of these problems remains difficult to measure because the FDA no longer requires abortion providers to report most nonfatal complications.”

Rojas also criticized the Center for Reproductive Rights for assessing the drug’s safety without considering its effect on unborn children, arguing that “no discussion of ‘safety’ can honestly ignore the unborn child.” 

“A successful chemical abortion always ends in death for that child,” he said. “The Center for Reproductive Rights focuses exclusively on maternal complication statistics because recognizing the second human being would expose the moral emptiness of its argument.”

“Mifepristone presents real dangers to women, and every successful use deliberately ends the life of an unborn child,” Rojas concluded. “Any honest examination of the drug must begin there.”