Second, there are questions about whether the FDA’s regulation of medication abortion trumps state abortions laws, potentially expanding medication abortion access even in states that attempt to ban all abortion. The U.S. Constitution provides that federal law preempts state law. The United States, the drug’s manufacturer, or a provider could bring a lawsuit arguing that a state cannot regulate medication abortion more harshly than the FDA, a federal entity. It’s clear that states cannot regulate drugs less harshly than the FDA. But whether the FDA’s regulation is just the nationwide floor or is also the nationwide ceiling is a complex question that might be different for different products. If it’s both, then states would not be able to ban an FDA-approved drug, especially one as closely regulated as mifepristone.
The preemption approach already is being tested in one court. The generic manufacturer of mifepristone filed a lawsuit in Mississippi arguing that the FDA’s regulations preempted some of Mississippi’s strict abortion laws. That case is languishing in pretrial motions and has not yet produced a ruling on the preemption issue. But eventually there will be a decision, and additional lawsuits using this theory will likely be filed, some even challenging a general abortion ban after Roe is overturned. Whether or not the FDA enters the fray and participates in this litigation, the agency will likely face pressure from both sides to assert its position on whether its regulations have preemptive effect.