do so via medication abortion. If access to mifepristone is halted, those seeking an abortion, and their providers, would have to choose between a surgical procedure or taking the other medication in the regimen, misoprostol, off-label on its own., alleges that the FDA did not adequately evaluate mifepristone’s safety before it approved the drug in 2000, and also argues the agency should not have made the medication accessible via telehealth during the pandemic.
But the Biden administration argues the group doesn’t have the legal standing to bring the lawsuit. That’s one of the issues Kacsmaryk has told the lawyers to prepare to address in the hearing, along with the potential harm of halting access to mifepristone and the implications of implementing such an order nationwide.
There is little legal precedent for a court to overturn a longstanding FDA approval, but abortion providers are nonetheless bracing for the possibility that Kacsmaryk — who was appointed by then-President Donald Trump — will grant the injunction request, since the judge has historically taken conservative stances on abortion rights and other issues.
Erik Baptist, senior counsel at Alliance Defending Freedom, the conservative Christian legal group representing the plaintiffs, said that “the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs.” “We are not seeking a nationwide abortion ban — we’re focusing on one means of abortion here because it’s dangerous, and we are holding the FDA accountable for failing America’s women and girls,” Baptist added.that the FDA reviewed the scientific evidence extensively before approving mifepristone, and that taking it off the market would cause worse health outcomes for people seeking abortions.