The Food and Drug Administration (FDA) recently approved a new generic version of abortion pill mifepristone, a move conservatives are blasting as a “complete betrayal” after Health Secretary Robert F. Kennedy Jr., pledged a thorough safety review of the drug.
Evita Solutions, the maker of the low-cost form of the pill that terminates pregnancies through 10 weeks, was notified by the FDA on Tuesday – one day before the government shutdown – that its “abbreviated new drug application” for mifepristone tablets had been approved.
“We have completed the review … and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval,” read the FDA’s letter to Evita Solutions.
Kennedy explained that the FDA was bound by federal law to approve the drug.
“[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,” the HHS secretary wrote on X.
The FDA is under the umbrella of the Kennedy’s Department of Health and Human Services, and the HHS secretary told congressional lawmakers earlier this year that he would order a “complete review” of mifepristone in response to a study that found some women experienced serious medical events after taking the drug.
“It’s alarming,” RFK Jr. said of the study conducted by the Ethics & Public Policy Center, which found nearly 11% of women who used mifepristone experienced a “serious adverse event.”
“I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,” the HHS secretary added during testimony before the Senate Health, Labor, Education and Pensions Committee in May.
Kennedy signaled that the FDA review was just getting underway earlier this month – 11 days before the mifepristone generic was approved – in a letter to Republican attorneys general.
“HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” Kennedy and FDA Commissioner Marty Makary wrote in their Sept. 19 letter.
“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” they added.Sen. Josh Hawley (R-Mo.), who pressed RFK on the safety of mifepristone during the May Senate hearing, called the FDA’s decision to approve a generic form of the pill “shocking.”
“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,” Hawley wrote on X.
“I have lost confidence in the leadership at FDA,” the senator added.
Former Vice President Mike Pence, who now runs Advancing American Freedom, a conservative advocacy group, called on Kennedy to resign.
“The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump,” Pence wrote on X.
“Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would expand access to abortion, as he has done today,” the former vice president continued.
Pence called on Trump to “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,” Pence added.
Kennedy’s staunch pro-choice views concerned some Republican lawmakers when he was tapped by Trump to lead HHS.
“I believe we should leave it to the woman, we shouldn’t have the government involved,” he said on the “Sage Steele Show” during his presidential campaign, later clarifying “even if it’s full term.”
Later, Kennedy explained that he believed “abortion should be unrestricted up until a certain point” and expressed a desire for policies to “reduce more abortions in America by choice than by force.”
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