The Biden administration had defended the rule, maintaining that mifepristone is safe and effective based on extensive clinical data. Federal health officials have pointed to studies showing serious adverse events occur in a small fraction of cases, generally cited as less than 1 percent.
The companies that manufacture and distribute the drug—Danco Laboratories, which produces the brand-name version Mifeprex, and GenBioPro, which makes a generic version—have intervened in the case to support the FDA’s position. Both companies have argued that restricting access would disrupt care and harm patients who rely on medication abortion, particularly in states with limited clinic availability.
