Scholars cite a Massachusetts Case 2014 in which the state sought to ban a new opioid, Zohydro ER, out of concern that the drug could be abused and lead to addiction or overdose. A federal judge sided with the pharmaceutical company, Zogenix. If the state “can overrule FDA decisions and replace its own claims, that would undermine FDA’s ability to provide drugs to promote and protect public health,” he said. ‘ wrote the judge. Further Massachusetts efforts to restrict Zohydro also rejected by the court.
Skye Perryman, an attorney for GenBioPro and president of Democracy Forward, a center-left legal advocacy group, said West Virginia’s ban is “an overstatement of state authority when a state attempts to replace FDA and make safety and effectiveness decisions that conflict with and interfere with FDA rulings.”
West Virginia passed an abortion ban in September. The lawsuit argues that the ban violates the constitutional supremacy clause, which says that federal law — in this case, the decision by Congress to authorize the FDA to administer drugs like mifepristone — takes precedence. take precedence over state conflict laws. The lawsuit also says such bans violate the commerce provision of the Constitution, which prohibits states from weakening interstate commerce.
GenBioPro, which began manufacturing conventional mifepristone in 2019, said that due to West Virginia’s ban and previously enacted abortion restrictions, the company was only able to ship 72 units of mifepristone for use during pregnancy. state, and by August 2022, the company’s sales were down to zero there. GenBioPro says its sales have fallen to zero in seven other states with abortion bans and in Wisconsin, where abortion services have been shut down due to unclear laws.
Dr DeShawn Taylor, chief medical officer of GenBioPro, said that the bans “deprived people of access to safe and effective medicines, and it also jeopardized our company. ” She added, “If people don’t have access to mifepristone, then of course that affects the bottom line of the company.” Dr. Taylor, an obstetrician-gynecologist who owns a family planning clinic in Arizona, also notes that mifepristone is commonly used to treat patients who have had a miscarriage.
One notable aspect of the FDA’s regulation of mifepristone is that over the decades the agency has imposed an additional framework of restrictions and oversight on the drug. Called Strategies for assessing and mitigating risksor REMS, it was used for there are only about 300 other drugs, only 60 of which are currently active in the framework. In recent years, the FDA has extensively reviewed new data on mifepristone and has lifted some restrictions, including requiring patients to receive the drug directly from a provider.
Some legal experts say the FDA’s decision to impose special restrictions on mifepristone and gradually relax some of those restrictions as evidence of safety and effectiveness grows, reinforcing the rationale. repeal state bans and restrictions, and assert that the federal government is the ultimate authority over drugs.
