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Scholars cite a 2014 Massachusetts case in which the state sought to ban a new opioid, Zohydro ER, because it worried that the drug could be abused and lead to addiction or overdose. A federal judge sided with the drug company, Zogenix. If the state “were able to countermand the F.D.A.’s determinations and substitute its own requirements, it would undermine the F.D.A.’s ability to make drugs available to promote and protect the public health,” the judge wrote. Subsequent efforts by Massachusetts to restrict Zohydro were also rejected by the courts.
Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization, said West Virginia’s ban was “an overreach of state authority when a state tries to step in the shoes of F.D.A. and to make safety and efficacy determinations that conflict with and interfere with F.D.A.’s judgments.”
West Virginia adopted an abortion ban in September. The suit contends that the ban violates the Constitution’s supremacy clause, which says that federal laws — in this case, Congress’s decision to authorize the F.D.A. to regulate drugs like mifepristone — have priority over conflicting state laws. The suit also says such bans violate the Constitution’s commerce clause, which prohibits states from impairing interstate commerce.
GenBioPro, which started making generic mifepristone in 2019, said that because of West Virginia’s ban and previously enacted abortion restrictions, it had been able to ship only 72 units of mifepristone to be used in the state and that by August 2022, its sales had dropped to zero there. GenBioPro said its sales had dropped to nothing in seven other states with abortion bans and in Wisconsin, where abortion services have stopped operating in light of unclear laws.
Dr. DeShawn Taylor, GenBioPro’s medical director, said that bans “deprive people of the ability to access safe and effective medications and it also jeopardizes our company.” She added, “If people don’t have access to mifepristone, then of course, it impacts the company’s bottom line.” Dr. Taylor, an obstetrician-gynecologist who owns a family planning clinic in Arizona, also noted that mifepristone is frequently used in treating patients who are experiencing miscarriages.
A notable aspect of the F.D.A.’s regulation of mifepristone is that for a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has been used for only about 300 other drugs, only 60 of which are currently actively under the framework. In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.
Some legal experts say the F.D.A.’s decision to apply special restrictions to mifepristone, and to gradually ease some of them as evidence of safety and efficacy has grown, strengthens the case for striking down state bans and restrictions and affirms that the federal government is the ultimate authority on the drug.
