Las Vegas, NV. – Today, GenBioPro, the nation’s only generic manufacturer of mifepristone, filed a 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 the use of mifepristone that existed before 2016. The 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 that decision is allowed to take effect.
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. The brief outlines the myriad of injuries GenBioPro would face as a result of the Fifth Circuit’s decision, including how the company would have to immediately stop selling its product because the labeling would instantly become inconsistent with the court-ordered methods of administration. What’s more, if the Fifth Circuit’s decision is upheld by the Supreme Court, GenBioPro will have to wait for FDA approval of Danco’s new label before it can then obtain approval. GenBioPro’s customers and partners would also be faced with uncertainty about whether and how they can distribute and use mifepristone already circulating in the marketplace.
“This legal attack on medical abortion has no basis in law or fact,” said GenBioPro CEO Evan Masingill. “Decades of science support mifepristone’s safety and efficacy. GenBioPro will continue to use all regulatory and legal tools to protect access to mifepristone for patients and providers. As we have said time and time again, GenBioPro firmly believes that all people, regardless of income, gender, race, or geography, have a right to access evidence-based health care and safe and effective medicines, and that includes medical abortion.”
Since its founding, GenBioPro has sought to make mifepristone more affordable and accessible. Consistent with that commitment, GenBioPro has challenged laws in the state of West Virginia that in effect ban mifepristone and brought suit to compel FDA to preserve availability to mifepristone in accordance with the law. In April, following an emergency petition to the Supreme Court filed by the federal government and the company that sought initial approval for mifepristone in 2000, GenBioPro submitted an amicus brief in support of a stay.
GenBioPro is represented on the brief by Arnold & Porter Kaye Scholer; Democracy Forward; and Kellogg, Hansen, Todd, Figel & Frederick.