The Food and Drug Administration (FDA) has given the green light to a new generic version of the abortion pill mifepristone, prompting strong criticism from conservatives who view the decision as a “total betrayal” after Health Secretary Robert F. Kennedy Jr. promised a comprehensive safety review of the medication.
Evita Solutions, the company producing the affordable version of the pill authorized for use in pregnancies up to 10 weeks, received notification from the FDA on Tuesday, just one day prior to the government shutdown, regarding the approval of their “abbreviated new drug application” for mifepristone tablets.
The letter from the FDA to Evita Solutions stated, “We have completed the review… and concluded that sufficient information was provided to demonstrate that the drug meets the criteria for approval.”
Kennedy highlighted that the FDA was compelled by federal law to authorize the drug.
The HHS secretary noted in a statement on X, “[FDA] only approved a second generic mifepristone tablet because federal law mandates approval when an application shows that the generic is identical to the brand-name drug.”
The FDA operates under the Kennedy-led Department of Health and Human Services, where earlier this year, the HHS secretary assured lawmakers that he would initiate a “complex review” of mifepristone in light of a study indicating some women faced serious health complications after using the drug.
Kennedy described the findings as concerning, referencing research by the Ethics & Public Policy Center that reported nearly 11% of women taking mifepristone encountered a “serious adverse event.”
“I instructed Marty Makary, the FDA director, to conduct a thorough review and provide feedback,” the HHS secretary stated during his testimony before the Senate Health, Labor, Education and Pensions Committee in May.
Kennedy indicated that the FDA’s assessment was just beginning earlier this month—11 days before the approval of the generic mifepristone—through a communication with Republican attorneys general.
“HHS—via the FDA—is performing its own inquiry into the evidence, including real-world outcomes and data, about the drug’s safety and effectiveness,” he and FDA Commissioner Marty Makary stated in their September 19 correspondence.
“This Administration will prioritize women’s health by thoroughly examining the conditions under which mifepristone can be safely distributed,” they emphasized.
Senator Josh Hawley (R-Mo.), who challenged RFK on mifepristone’s safety during the May Senate session, deemed the FDA’s approval of a generic version of the drug as “shocking.”
“The FDA committed to conducting a complete safety review of the chemical abortion drug, yet they have simply authorized additional versions for distribution,” Hawley noted on X.
“I have lost faith in the FDA’s leadership,” the senator remarked.
Former Vice President Mike Pence, currently leading the conservative group Advancing American Freedom, has called for Kennedy’s resignation.
“The Trump Administration’s endorsement of a generic abortion medication is a flagrant betrayal of the pro-life movement that brought President Trump to power,” Pence posted on X.
Pence expressed earlier concerns during RFK’s nomination that he was not suitable for the role, particularly due to fears he would promote increased access to abortion, a worry that became evident with the recent approval.
Pence urged Trump to “swiftly reverse this decision.”
“RFK must resign and allow President Trump to appoint a new HHS Secretary who will defend the sanctity of life,” he concluded.
Kennedy’s outspoken pro-choice stance raised eyebrows among Republican legislators when he was appointed to head HHS.
During his presidential campaign, he stated, “I believe decisions should be left to the woman, without government interference,” later clarifying his position even in the context of full-term pregnancies on the Sage Steele Show.
Later, Kennedy noted his belief that “abortion should be unrestricted up to a certain point” and he advocated for policies that aim to “reduce abortions in America through choice rather than coercion.”
