GenBioPro, the leading supplier of the generic abortion pill mifepristone, has urged a federal appeals court to affirm that West Virginia’s stringent abortion restrictions do not apply to the medication when used in accordance with FDA guidelines. The company’s appeal, presented before the 4th U.S. Circuit Court of Appeals, asserts that federal law preempts state regulations concerning the drug’s use.
David Frederick, representing GenBioPro, argued that the core issue is whether West Virginia can disrupt the regulatory balance the FDA maintains to ensure safe access to mifepristone. “The answer is no,” he stated, emphasizing the FDA’s exclusive authority over the regulation of medication abortion.
Mifepristone, used in conjunction with misoprostol, is approved for medication abortion within the first ten weeks of pregnancy, as stipulated by the FDA’s safety requirements. GenBioPro maintains that federal law supersedes West Virginia’s 2022 abortion law, which imposes severe limitations on abortion access, permitting the procedure only under specific circumstances.
The case originates from a lawsuit filed by GenBioPro in 2022, challenging the state’s restrictive measures. The company seeks to overturn a previous ruling by U.S. District Judge Robert Chambers, who supported the state’s position by asserting that the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization granted states greater authority to regulate abortion.
During the hearing, Erin Hawley of the conservative legal group Alliance Defending Freedom defended the state’s interests, insisting that states retain the right to regulate healthcare practices, including prescription medications like mifepristone.
However, the panel of judges expressed skepticism about the state’s authority to impose such restrictions. Judge J. Harvie Wilkinson remarked that federal regulations serve as a baseline, allowing states the option to impose stricter regulations but not to obstruct FDA-approved practices. Judge Rossie Alston echoed this sentiment, suggesting that the Supreme Court’s decisions generally delegate regulation of abortion to the states.
As the case unfolds, GenBioPro remains committed to advocating for reproductive rights and ensuring access to safe and legal medication abortion across the United States.
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