(Oregon Right to Life) — The U.S. Food and Drug Administration (FDA) last week sparked controversy among pro-life advocates after it approved a generic version of the abortion drug mifepristone amid the ongoing government review of the pill’s safety.
On Thursday, the FDA granted approval for a generic mifepristone pill manufactured by Evita Solutions.
Evita Solutions says it seeks to “destigmatize abortion care” and “commit to making care accessible to all.” On its website, the company declares that “reproductive rights are human rights,” going on to claim that “[m]edical abortion care is rife with medically unnecessary restrictions and social stigma in the United States.” However, the safety information listed on the website itself acknowledges that “serious and sometimes fatal infections or bleeding” may occur after taking the drug.
Some pro-life advocates responded by criticizing the FDA for approving the drug while simultaneously carrying out a review of its safety.
In an October 2 social media post, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. clarified the reason for the FDA approval.
“[The FDA] only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug,” Kennedy said on X. The Hatch-Waxman Act requires FDA approval of generic drugs that meet existing statutory and regulatory requirements.
Kennedy also reiterated that the FDA is actively investigating the safety of mifepristone following the rollback of safety regulations under the Biden administration.
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“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” Kennedy said.
“Last month, I joined [United States Commissioner of Food and Drugs Dr. Marty Makary] in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug,” he said. “Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
As Oregon Right to Life previously reported, the HHS last month sent a letter to nearly two dozen state attorneys general acknowledging the reported dangers of mifepristone and affirming they are actively reviewing the drug’s safety.
In the September 19 letter obtained by The Gateway Pundit, Secretary Kennedy and FDA Commissioner Dr. Makary pledged to “ensure that women’s health is properly protected by investigating the circumstances under which mifepristone can be safely dispensed.”
RELATED: HHS Provides New Update on Review of Abortion Pill Dangers
In a statement, National Right to Life president Carol Tobias acknowledged that the FDA’s approval of the generic abortion pill was mandated by law, and pointed to the underlying issue – the dangers of the abortion pill for women and the unborn.
“We must confront the reality of chemical abortion drugs,” Tobias said in a statement shared with Oregon 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.”
“Mifepristone is the only drug on the market that was created to take lives,” she added. “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.”
As Tobias mentioned, recent reporting suggests that the abortion pill poses far greater risks to pregnant women than previously known.
The Ethics and Public Policy Center (EPPC) released the study this summer based on an analysis of public and private insurance claims submitted by 330 million U.S. patients from 2017 to 2023. In the report, the EPPC calculated the severe complication rate associated with the drug to be twenty-two times the one currently listed on the drug’s official FDA label.
A white paper released by NRLC last month also shines a spotlight on the abortion pill’s risks, showing that adverse events, including “hemorrhage, infection, and incomplete abortions often go unrecorded in official data, giving the public a misleading picture of safety,” according to the NRLC press release.
