The U.S. Food and Drug Administration has approved a new generic version of the abortion drug mifepristone, to be marketed by Evita Solutions. The company now joins GenBioPro as a manufacturer of a generic form of the drug, which is typically used with misoprostol to induce a medical abortion.
The decision follows standard regulatory rules: if a generic drug is shown to be bioequivalent to an already approved product, the agency is required to grant approval, even without new safety data.
The new generic has been approved for use in ending pregnancies up to 10 weeks gestation. The decision drew sharp criticism from social conservatives, who said it runs counter to the Trump administration’s pro-life stance. But the FDA and the Department of Health and Human Services said their discretion is limited, noting that U.S. law requires approval when a generic meets equivalence standards.
At the same time, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have announced a broader review of mifepristone’s safety, which will continue alongside the new approval.
As reported by Bloomberg Law:
The approval follows a letter from FDA commissioner Marty Makary and US Department of Health and Human Services Secretary Robert F. Kennedy Jr. stating they would open an investigation into safety and efficacy of the abortion pill mifepristone.
That investigation came after a controversial study from the faith-based group Ethics and Public Policy Center found potential adverse effects from using the drug.
Kennedy told lawmakers at a Sept. 4 Senate Finance Committee hearing that the Biden administration “twisted the data” on the safety of mifepristone. Kennedy said the Trump administration was committed to reviewing mifepristone safety and keeping politics out of his approach.
“The FDA has very limited discretion in deciding whether to approve a generic drug,” HHS spokesperson Andrew Nixon said in an email Thursday. “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 explained that the federal government was closely examining the abortion pill. “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.”
Kennedy reiterated the same position on his social media, amplifying the administration’s message.
He criticized the White House for acting too quickly. “The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” he said. He added that 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.”
Mifepristone was first approved by the FDA in 2000 under the brand name Mifeprex. A generic version by GenBioPro was cleared in 2019 after years of review. In 2024, the Supreme Court unanimously ruled that lawsuits seeking to revoke or restrict approval of the drug failed because challengers lacked legal standing, reaffirming that mifepristone remains legally available under FDA rules.
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