Las Vegas, NV. – Today, GenBioPro, the nation’s only generic manufacturer of mifepristone, filed an appeal in GenBioPro, Inc. v. Raynes – a legal challenge to invalidate West Virginia’s medication abortion ban and restrictions.
The appeal comes on the heels of the company’s October 12 amicus brief at the United States Supreme Court urging the Court to review the Fifth Circuit Court of Appeal’s August 16 ruling that would compel the U.S. Food and Drug Administration (FDA) to reinstate its conditions on mifepristone that existed before 2016. That brief, which outlines the “severe” real-world consequences of the Fifth Circuit’s decision, highlights the specific impact on GenBioPro and the larger healthcare community if the Fifth Circuit’s decision is allowed to take effect.
“GenBioPro is committed to delivering on our belief that everyone has a right to access evidence-based health care and safe and effective medicines, and that includes medical abortion,” said GenBioPro CEO Evan Masingill. “In affirmation of that commitment, we are taking the necessary next step in our ongoing efforts to make mifepristone accessible to all by appealing the decision in our case in West Virginia.”
“Today’s appeal is a critical next step in our fight to protect access to medication abortion,” said Skye Perryman, President and CEO of Democracy Forward, who is also serving as counsel for the company. “West Virginia’s decision to step in where Congress has granted FDA the authority to regulate mifepristone is unlawful and could undermine not only access to medication, but the country’s entire drug regulation system. What’s more, decades of science support mifepristone’s safety and efficacy and it is unacceptable that people living in West Virginia who need this basic health care are being forced to travel out of state or forgo care altogether. We look forward to continuing to represent GenBioPro in the further stages of this case.”
GenBioPro has held an FDA approval for generic mifepristone since 2019 and currently makes up a majority of the market for mifepristone in the United States. After the FDA allowed certified pharmacies to dispense mifepristone earlier this year, GenBioPro recently made available updated information about accessing mifepristone, including pharmacies that it had certified.
GenBioPro is represented in this case by Kellogg, Hansen, Todd, Figel & Frederick, Democracy Forward; and Arnold & Porter Kaye Scholer.