The FDA and Danco, maker of Mifeprex, the brand name of mifepristone, argue a court order rolling back the actions is improper for several reasons, including because the group that obtained it, the Alliance for Hippocratic Medicine, has no standing to challenge the agency’s decisions. The FDA additionally claims it did not arbitrarily make the post-approval changes, but instead made them after an extensive review process, and that the court order rolling them back is too broad.
The Alliance refutes those arguments, maintaining it has standing because the agency’s actions would force its members to treat individuals experiencing complications related to mifepristone in spite of their anti-abortion beliefs. The group also contends the FDA’s review process wasn’t thorough enough because the agency ignored information about the purportedly harmful side effects of mifepristone.
A majority of the Supreme Court appeared skeptical of the Alliance’s standing theory during oral arguments in March, and some individual justices expressed doubt about the group’s critiques of the FDA’s review process.
