The researchers cite a 2014 Massachusetts case in which the state sought to ban a new opioid, Zohydro ER, because it feared the drug could be abused and lead to addiction or overdose. A federal judge has sided with pharmaceutical company Zogenix. If the state “were able to overrule FDA decisions and substitute its own requirements, it would compromise the FDA’s ability to make drugs available to promote and protect public health,” the judge wrote. Subsequent efforts by Massachusetts to restrict Zohydro were also rejected by the courts.
Skye Perryman, GenBioPro attorney and president of Democracy Forward, a center-left legal advocacy organization, said West Virginia’s ban was “an excess of state authority when a state attempts to put themselves in the shoes of the FDA and make safety and efficacy decisions. that conflict and interfere with FDA judgments.
West Virginia passed an abortion ban in September. The lawsuit argues that the ban violates the Constitution’s Supremacy Clause, which states that federal laws — in this case, Congress’s decision to authorize the FDA to regulate drugs like mifepristone — take precedence over state laws. conflicting states. The lawsuit also says such bans violate the Commerce Clause of the Constitution, which prohibits states from obstructing interstate commerce.
GenBioPro, which began manufacturing generic mifepristone in 2019, said due to West Virginia’s ban and previously enacted abortion restrictions, it was only able to ship 72 units of mifepristone. for use in the state and that by August 2022 its sales had dropped to zero there. GenBioPro said its sales fell to zero in seven other abortion-banning states and in Wisconsin, where abortion services shut down in light of unclear laws.
Dr. DeShawn Taylor, chief medical officer of GenBioPro, said the bans “deprive people of the ability to access safe and effective medicines and also put our business at risk.” She added: “If people don’t have access to mifepristone, of course that has an impact on the bottom line of the business.” Dr. Taylor, an obstetrician-gynecologist who owns a family planning clinic in Arizona, also noted that mifepristone is frequently used to treat patients who experience miscarriages.
A notable aspect of the FDA’s regulation of mifepristone is that for the past dozen years, the agency has imposed an additional framework of restrictions and oversight on the drug. Called the Risk Assessment and Mitigation Strategy, or REMS, it has only been used for about 300 other drugs, of which only 60 are currently actively covered by the framework. In recent years, the FDA has thoroughly reviewed new data on mifepristone and lifted several of the restrictions, including the requirement that patients obtain the drug in person from a supplier.
Some legal experts say the FDA’s decision to apply special restrictions to mifepristone, and to gradually relax some of them as evidence of safety and effectiveness grows, bolsters the case for overriding state bans and restrictions and asserts that the federal government is the ultimate authority. on the drug.