GenBioPro, Manufacturer of Generic Mifepristone, Responds to Texas Court Staying Florida et al. v. FDA Case

Patients’ Access to Mifepristone Nationwide Remains Unchanged for Now

September 1, 2026 - Wichita Falls, Texas – On Monday, the U.S. District Court for the Northern District of Texas, Wichita Falls Division denied GenBioPro’s motion to dismiss Florida et al. v. FDA, but granted the Department of Justice’s motion to stay the case through December 1, 2026, or until the Food and Drug Administration (FDA) completes its already announced review of mifepristone, whichever occurs sooner. This decision ensures that access to mifepristone will continue for now. Although the complaint was brought by the states of Florida and Texas, if their lawsuit ultimately succeeds, all Americans would lose access to mifepristone.

 With this granted stay, the current state-by-state legal access to mifepristone will not change across the country. The stay was granted with agreement by the states of Florida and Texas, who are asking the court to entirely eliminate nationwide access to mifepristone by rolling back the FDA’s approval of mifepristone in 2000 and reversing every decision FDA has made about mifepristone since – despite mifepristone’s overwhelming safety as demonstrated through decades of real world use, as well as a large body of scientific literature and evidence. 

GenBioPro, manufacturer of generic mifepristone, formally intervened in the case to defend the FDA’s approval of their product on April 28, 2025. 

“Ensuring legal access to mifepristone in the long term is vital to women’s healthcare and reproductive freedom. We expect the FDA’s review of mifepristone to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective,” said GenBioPro CEO Evan Masingill.  “GenBioPro will continue to use all legal and regulatory tools available to ensure Americans’ access to reproductive care.”

GenBioPro is represented in the suit by Democracy Forward Foundation and Arnold & Porter.

“The FDA has affirmed time and again that mifepristone is safe and effective,” said Skye Perryman, President and CEO of Democracy Forward. “Far-right, anti-science extremists may be pressuring the Trump-Vance administration to reach a different, ideologically-driven outcome, but we will continue to represent our clients to hold the FDA to the same science-based standards it has long applied to protect people’s ability to access effective, evidence-based healthcare, including protecting access to medication abortion.”

This ruling comes as two related cases threatening access to mifepristone are pending in other federal courts. Louisiana v. FDA, which threatens to restore an outdated and medically unnecessary requirement that mifepristone be dispensed in person, is pending in the Fifth Circuit Court of Appeals with oral arguments scheduled for September 9, 2026. In Missouri et al. v. FDA, pending in the Eastern District of Missouri, the states of Missouri, Kansas, and Idaho seek to reinstate the conditions on the use of mifepristone that existed before 2016, threatening to make the medication unavailable nationwide.

Source: Democracy Forward