The FDA has given the green light to a new generic version of mifepristone, a drug used for abortions, which is being met with backlash. It’s seen by some as a “complete betrayal,” especially after Health Secretary Robert F. Kennedy Jr. promised a thorough safety review of the medication.
Evita Solutions, the company producing these affordable tablets that can terminate a pregnancy within ten weeks, received notification from the FDA on Tuesday—right before a potential government shutdown—that their application for mifepristone tablets had been approved.
“We have completed our review and found sufficient information demonstrating that the drug meets the criteria for approval,” stated the FDA in a letter addressed to Evita Solutions.
Kennedy commented that the FDA was legally obligated to approve the drug. He noted, “[The FDA] approved only the second generic mifepristone tablets because federal regulations necessitate approval if the application is shown to be identical to an existing drug.”
The FDA operates under Kennedy’s Department of Health and Human Services, and earlier this year, he indicated that he would mandate a “full review” of mifepristone following reports of serious medical incidents connected to its use.
“That’s incredible,” Kennedy remarked regarding a study from the Center for Ethics & Public Policy, which revealed that nearly 11% of women taking mifepristone experienced severe adverse effects.
During a Senate committee hearing in May, he urged FDA Director Marty McCurry to carry out a comprehensive review and provide a report.
Interestingly, a recent letter from Kennedy to a Republican Attorney General shows that the FDA’s review only began recently—just 11 days prior to the approval of the generic mifepristone.
“The FDA undertakes a unique examination of evidence related to drug safety and effectiveness,” commented Kennedy and FDA Commissioner McCurry in the letter.
They stressed that the administration was committed to safeguarding women’s health through an in-depth investigation into how mifepristone can be safely managed.
Senator Josh Hawley (R-Mo.), who had previously raised safety concerns with Kennedy, reacted strongly against the FDA’s approval, labeling it “shocking.” He criticized the agency, saying that it had promised rigorous safety evaluations for chemical abortion drugs, yet appeared to have approved new versions for distribution.
Hawley expressed deep dissatisfaction, stating, “I’ve lost trust in the FDA leadership.”
Former Vice President Mike Pence has also called for Kennedy to step down, declaring that the decision to approve this common abortion drug represents a betrayal of the pro-life movement that supported Trump.
Pence shared on social media, “I previously opposed Kennedy’s nomination due to concerns about expanding abortion access, which he just affirmed with this decision.”
He urged Trump to retract this approval and suggested that RFK should resign, allowing for a new HHS secretary committed to protecting life.
Kennedy’s pro-choice stance had raised eyebrows among some Republican lawmakers when he was appointed by Trump. He previously stated, “We believe control over this matter should be in the hands of women, not the government.”
In a later discussion, he clarified his beliefs regarding abortion, saying he supports it to certain limits and advocates for a strategy aimed at reducing abortions through choice rather than coercion.
