Days after FDA Commissioner Marty Makary said that the agency planned to review the safety of abortion pill mifepristone, attorneys general from four pro-choice states have fired back, filing (PDF) a petition asking the U.S. regulator to lift restrictions on the treatment.
The goal of the petition, according to The New York Times, is not necessarily to erase the Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, but instead to force the FDA to review and acknowledge the voluminous data demonstrating the safety of the pill, which has been on the market for 25 years.
The Times cites an anonymous source from the Massachusetts attorney general’s office, who is working on the petition. The other state attorneys who have signed onto the effort are from California, New Jersey and New York.
The purpose of the petition is in part to debunk a report from the Ethics and Public Policy Center, an anti-abortion conservative think tank, which questions the safety of mifepristone and has gained traction with anti-abortionists, even though it lacks the peer-reviewed stamp of approval generally required to legitimize such data. While the report analyzes insurance claims data, it doesn’t reveal the source of the information.
In a letter to Makary in late April, Republican Sen. Josh Hawley of Missouri cited the report in urging the FDA to conduct the review of mifepristone.
Two weeks later, Health and Human Services Secretary Robert F. Kennedy Jr., testified before the Senate Health, Education, Labor and Pensions Committee that he ordered Makary to conduct a “complete review” of mifepristone.
Since the Supreme Court overturned Roe vs. Wade in 2022 and allowed states to individually outlaw abortions, the use of mifepristone has surged in the U.S.
A year ago, a Supreme Court ruling preserved mail-order access to the drug. The practice of mailing mifepristone gained traction after a 2021 FDA decision in which the agency removed an in-person administration requirement for the drug.
As for the petition, the FDA has 180 days to respond. If the regulator dismisses the petition, it could set up a court challenge.
The review puts the FDA in a precarious position, serving under the anti-abortion administration of President Donald Trump. If the Republican push is successful, it raises the question of whether certain vaccines or other medicines could become more closely scrutinized based on flawed, agenda-driven data.