The pharmaceutical company GenBioPro filed a motion on Tuesday, Feb. 25, to intervene in Missouri et al. v. FDA, a lawsuit in Texas challenging FDA regulation of the drug mifepristone, which is part of a two-drug regimen for the termination of early pregnancy. GenBioPro is the sole U.S. manufacturer of generic mifepristone, which the FDA approved in 2019 and is now the majority of mifepristone sold in the U.S.
In the Texas lawsuit, the attorneys general of Missouri, Kansas and Idaho are attempting to remove generic mifepristone from the market and severely restrict the brand-name mifepristone, Mifeprex made by Danco, in all 50 states and U.S. territories.
“All people have a right to access safe, affordable, evidence-based healthcare, and GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone for millions of patients and providers across the country,” said Evan Masingill, CEO of GenBioPro.