A senior Food and Drug Administration official said the agency has launched a retrospective safety study of mifepristone, reviewing hundreds of thousands of cases with interim results that could be released in July.
The official said the timing of final results will depend on the design of a secondary analysis after the interim results come in.
Last September, Health and Human Services Secretary Robert F. Kennedy Jr. wrote in a letter to several Republican state attorneys general that the FDA was reviewing the safety of mifepristone. Kennedy and then-FDA Commissioner Martin Makary wrote, "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."
The drug came under renewed scrutiny after the Biden administration issued a memorandum lifting restrictions that required the drug to be dispensed in person and giving access to mifepristone via telehealth and by mail.
Last year, the state of Louisiana filed a lawsuit challenging the FDA's decision to allow mifepristone to be delivered by mail. On May 4, the U.S. Court of Appeals for the 5th Circuit temporarily reinstated the rule requiring mifepristone to only be dispensed in person.
The following week, the Supreme Court set aside the lower court order and allowed mifepristone to continue to be delivered to patients through the mail while the Louisiana case plays out in the courts.
Mifepristone was first approved by the FDA in 2000 as a safe way to end early pregnancies and is typically taken with a second drug, misoprostol.
Dr. Celine Gounder, a medical contributor, said it would be difficult for the FDA to withdraw approval but that depending on what the safety review finds it could make access more difficult, limiting availability through telehealth or by mail, or restricting the ability to prescribe it to doctors rather than physician assistants or nurses.
The move has been described as a victory for anti-abortion groups and could pave the way for the Trump administration to seek restrictions on how the drug is used and distributed.