This post was originally published on this site
The states consider it a move to force the F.D.A. to review and acknowledge extensive research showing the pill’s safety.
In a strategy aimed at countering efforts to further restrict the abortion pill mifepristone, attorneys general of four states that support abortion rights on Thursday asked the Food and Drug Administration to do the opposite and lift the most stringent remaining restrictions on the pill.
The petition filed by Massachusetts, New York, California and New Jersey might seem surprising given the opposition to abortion expressed by Trump administration officials. But the attorneys general consider it a move that would require the F.D.A. to acknowledge extensive scientific research that has consistently found mifepristone safe and effective, said an official with the Massachusetts attorney general’s office who worked on the filing and asked not to be named in order to share background information. It would also prevent the F.D.A. from changing mifepristone regulations while the petition is pending.
The petition notes that at a May senate hearing, Robert F. Kennedy Jr., the health and human services secretary, responded to questions by Senator Josh Hawley, Republican of Missouri, who opposes abortion, by saying he had ordered the F.D.A. to do a “complete review” of mifepristone.
“We want to make sure that when F.D.A. is making these decisions that they have all the data in front of them, all of the really powerful data that show that mifepristone is safe” the Massachusetts official said.
The F.D.A. is required to respond within 180 days by granting or denying the request, or saying it needs more time. In its responses, the agency must document its position, which could be useful in lawsuits, including one that the four states could file if their petition is denied.
Mifepristone, which blocks a hormone necessary for pregnancy development, was approved for abortion in America in 2000. The F.D.A. imposed an additional regulatory framework called Risk Evaluation and Mitigation Strategy, or REMS, on mifepristone. That framework has been used for only about 300 drugs, currently covering only about 60 medications.