GenBioPro Sues FDA To Keep Generic Mifepristone Available; Supreme Court Delays Its Decision

The legal battle over mifepristone took a sharp twist with GenBioPro suing the US Food and Drug Administration to prevent it from taking civil and criminal enforcement actions against the company if the US Supreme Court does not halt a Texas district court order staying approval of the medication abortion drug. The suit also asks the court to require FDA to follow regulatory procedures before altering the availability or status of its generic mifepristone product.

Janet Woodcock, FDA’s deputy principal commissioner, laid out what the agency and sponsors will have to do if the order goes into effect in a declaration included in the Department of Justice’s application to the Supreme Court for an emergency stay of the decision by US District Judge Matthew Kacsmaryk of the Northern District of Texas. She said mifepristone would become misbranded, approval of GenBioPro’s generic would be stayed altogether and the company would have to file another abbreviated new drug application