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.
Last June, the Supreme Court dismissed the original lawsuit, Alliance for Hippocratic Medicine v. FDA, in a 9-0 ruling that the plaintiffs—a group of antiabortion activists—lacked standing to bring the lawsuit. When it became clear the Supreme Court was going to dismiss the lawsuit, the attorneys general of Missouri, Kansas and Idaho filed a motion to intervene, which was quickly granted by rabid antiabortion Judge Matthew Kacsmaryk. The revived lawsuit adds allegations specifically challenging the FDA’s 2019 approval of GenBioPro’s generic mifepristone.
“Even after the US Supreme Court ruled last year that the anti-science extremists bringing this case lacked standing, ideologically-driven far-right state attorneys general are continuing to weaponize our courts to try to push their agenda,” said Skye Perryman, president and CEO of Democracy Forward, who is also serving as counsel for the company.
These politicians remain determined to severely restrict access to a critical drug that women across America depend on.
Skye Perryman
GenBioPro is arguing that the states of Missouri, Kansas and Idaho have no basis to sue in Texas, rather than in their own states, and that they also lack standing to challenge the FDA’s approval and regulation of mifepristone.
“Despite the overwhelming majority of Americans—including constituents of these attorneys general—supporting the legal right to abortion, these politicians remain determined to severely restrict access to a critical drug that women across America depend on,” said Perryman.
In November 2024, Missouri voters approved a constitutional amendment to legalize abortion in the state.
In August 2022, Kansas voters overwhelmingly rejected a ballot measure to restrict abortion in that state.
In Idaho, a recent poll showed that most voters disagreed with the state’s abortion ban.
“I am appalled that our attorney general, Raúl Labrador, is disregarding the will of the majority of Idahoans and endangering the health and well-being of women and girls in Idaho and across the nation,” said Caren DeAngelis, a Boise mother of two daughters. “I’m also really angry that this right-wing extremist is wasting taxpayer dollars on a bogus lawsuit.”
Perryman argues the lawsuit could destabilize the pharmaceutical industry and block access to life-saving medications and vaccines. “Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation’s drug regulation system,” said Perryman.
In the original lawsuits, pharmaceutical companies and executives came out in force in opposition to the attempt to politically meddle in the FDA drug approval process, which if allowed would endanger their ability to market their drugs and disincentivize developing new drugs.
“We remain concerned about extremists and special interests’ attempts to undermine the U.S. Food and Drug Administration’s regulatory authority,” said Masingill.
Missouri, Kansas and Idaho are arguing that the court should restore the conditions of mifepristone’s use that existed before 2016, including requiring a medically unnecessary in-person visit for a medication abortion, revoking prescribing authority from health care providers who otherwise prescribe medications, preventing pharmacies from dispensing the product and restricting use to the first seven weeks of pregnancy.
“This case should be dismissed outright on procedural grounds and, at a minimum, it cannot proceed in Texas,” said Daphne O’Connor of Arnold & Porter, who represents GenBioPro. “The lawsuit itself is also meritless because FDA regulates generic mifepristone based on decades of experience and extensive scientific evidence and there is no basis for a court to second-guess FDA’s reasoned decision-making.”
