In a letter sent earlier this month but made public on Tuesday, Health Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary said the agency is considering modifying the Risk Evaluation and Mitigation Strategy requirements.
The duo wrote that the review was spurred by “recent studies raising concerns about the safety of mifepristone as currently administered,” but said HHS will be “conducting its own review” of the medication.
The update to states comes as HHS is feeling pressure from anti-abortion advocates and lawmakers to restrict access to mifepristone.
The FDA first approved mifepristone in 2000 for abortion up to seven weeks of pregnancy, but then made a series of changes in 2016 and 2021.
Those changes included increasing the gestational age at which mifepristone can be used to up to 10 weeks of pregnancy, allowing the medication to be mailed to patients, lowering the dosage, approving telehealth prescribing and permitting providers other than physicians to prescribe the drug.
The FDA has repeatedly found that mifepristone is safe and that a medication abortion regimen that includes mifepristone and a second drug, misoprostol, is a safe and effective alternative to surgical abortions.
But anti-abortion groups contend the drugs are dangerous.
It’s not clear if Kennedy and Makary will go so far as to suggest the drug be removed from the market. But they have cited findings from a study conducted by the conservative think tank Ethics and Public Policy Center (EPPC) as a reason to at least revisit the Biden administration’s changes.
The two health leaders wrote that “safeguards for women regarding the administration” of mifepristone have been “significantly reduced.”
