Pro-lifers are fuming at the Trump administration for approving a generic version of the abortion drug mifepristone that is produced by a pro-abortion company.
On Thursday, the Food and Drug Administration quietly approved Evita LLC’s application to produce a generic version of mifepristone, even as the agency investigates whether mifepristone is more dangerous than previously thought.
Evita LLC’s mission is to “normalize abortion” and make it “accessible to all,” the opposite of what pro-lifers are trying to accomplish. Pro-lifers immediately criticized the FDA’s approval and blasted the Trump administration’s leading health officials.
“The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump,” said former Vice President Mike Pence, who served with Trump in his first term.
“President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life.”
Senator Josh Hawley, a member of the Senate Committee on Health, Education, Labor, and Pensions, said he has “lost confidence” in the FDA’s leadership because of the approval.
“This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” Hawley stated.
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA.”
A Christian pro-lifer, Hawley has consistently pushed the Trump administration to limit the distribution of mifepristone. Similarly, Representative Riley Moore (R., W.Va.), an outspoken Catholic, asked the FDA to quickly reverse its decision.
“Chemical abortion kills children and harms mothers. Today’s announcement is a travesty and I urge @SecKennedy and @DrMakaryFDA to reverse course immediately,” Moore said on social media.
In response to the outrage, HHS communications director Andrew Nixon explained that the FDA lacks discretion in approving generic drugs and referred to its ongoing review.
“The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Nixon said.
“Generic applicants are not required to submit independent evidence proving safety and effectiveness. HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
The FDA officially began its mifepristone review earlier this month after Commissioner Marty Makary promised to oversee it. Pro-lifers highlighted the importance of the FDA’s review given its approval of Evita Solutions’s abortion drug.
“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable. These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,” said Marjorie Dannenfelser, president of Susan B. Anthony pro-life America.
“The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug.”
Health and Human Services Secretary Robert F. Kennedy Jr. promised earlier this year that the FDA would review mifepristone after a study from the conservative Ethics and Public Policy Center found that it led to a serious adverse effect in almost 11 percent of cases. Kennedy has floated changing mifepristone’s label because of the study’s results.
Kennedy referred to the study and the FDA’s ongoing review in a statement explaining why the agency approved the generic abortion drug.
“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” Kennedy said.
“Recent studies already point to serious risks when mifepristone is used without proper medical oversight. @US_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,” he added.
The EPPC’s finding suggest the amount of adverse effects suffered by women within 45 days of taking mifepristone is 22 times higher than what the FDA’s current label indicates. Sepsis, infection, and hemorrhaging are the main adverse effects mentioned in the study.
Abortion advocates have dismissed the EPPC study for not being peer-reviewed. EPPC said the paper was not peer-reviewed because of anti-conservative bias in the process and the demonstrable replicability of the study. The EPPC study evaluated an insurance claims database with 865,727 prescribed mifepristone abortions from 2017-23, a significantly larger dataset than the combined sample of FDA-cited studies.
The availability of mifepristone is a central pillar of the abortion battle. A study from the pro-abortion Guttmacher Institute last year found that over 60 percent of all abortions are chemical abortions. Pro-abortion groups have falsely argued mifepristone is as safe as Tylenol in their legal and political fight against restricting it. Democratic-run states have embraced abortion tourism and mail-in abortion drugs in order to dodge red-state abortion restrictions enacted after Roe v. Wade was overturned in 2022.