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FDA approves generic version of mifepristone abortion drug, sparking conservative backlash

The approval comes just days after Health and Human Services Secretary Robert F. Kennedy, Jr., said the FDA would review its existing approvals of brand-name mifepristone.
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The Food and Drug Administration this week approved a generic version of mifepristone, the drug most commonly used to terminate pregnancy during a medication-induced abortion.

The drug is the second version of generic mifepristone to be marketed.

It comes just days after Health and Human Services Secretary Robert F. Kennedy, Jr., said the FDA would review its existing approvals of mifepristone.

In a letter to state attorneys general, Secretary Kennedy and FDA commissioner Dr. Marty Makary said the agency would revisit the Risk Evaluation and Mitigation Strategy for mifepristone.

The letter points to a study from the Ethics and Public Policy Center, a conservative think tank with ties to the Heritage Foundation and Project 2025, that claimed to show that 11% of women taking the drug experienced "serious adverse events." The study was not peer reviewed; previous research cited by the FDA when approving the drug showed an adverse event incidence rate of just 0.5%.

"The FDA has very limited discretion in deciding whether to approve a generic drug," said HHS spokesman Andrew Nixon. "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."

"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."

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Thursday's approval of the generic version of the drug drew swift criticism from Republican lawmakers and pro-life groups.

Sen. Josh Hawley (R-MO) called the news "shocking" and said he had lost confidence in FDA leadership as a result of the approval.

“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable," said Susan B. Anthony Pro-Life America President Marjorie Dannenfelser. "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."