Drugmakers move to defend abortion pill access from Louisiana's lawsuit

By Daniel Wiessner

Feb 5 (Reuters) - Drug companies GenBioPro and Danco Laboratories have moved to defend against Louisiana's legal challenge to a federal regulation allowing abortion pills to be dispensed through the mail after President Donald Trump's administration suggested that it was invalid.

The companies in separate filings in Lafayette, Louisiana, federal court on Tuesday said there is no scientific evidence that supports reversing the U.S. Food and Drug Administration's 2023 decision to stop requiring the abortion drug mifepristone to be dispensed in person.

Louisiana sued the FDA in October, claiming the agency had ignored the safety risks of easing access to mifepristone, which is used in approximately 60% of U.S. abortions. The Republican-led state has moved for a preliminary injunction blocking the rule pending the outcome of the case.

The FDA last year launched a review of mifepristone, which has reportedly been delayed until after the November 2026 midterm elections. The Trump administration last week moved to pause Louisiana's lawsuit pending completion of the review, and in doing so echoed the FDA's claim from last year that the agency did not adequately consider the consequences of the 2023 rule.

The brand-name of mifepristone, Mifeprex, is Danco's only product, and GenBioPro derives most of its revenue from the generic version, the companies said in the filings. Blocking mail-order prescriptions would disrupt the companies' businesses and curtail access to mifepristone nationwide, they said.

"We are increasingly concerned by extremists’ complete disregard for the large body of scientific evidence supporting mifepristone’s use and safety,” GenBioPro CEO Evan Masingill said in a statement.

The companies asked U.S. District Judge David Joseph, a Trump appointee, to permit them to intervene in the case.

The office of Louisiana Attorney General Liz Murrill, a Republican, and the FDA did not immediately respond to requests for comment on Wednesday.

Nearly half of U.S. states have banned or severely restricted abortion since the U.S. Supreme Court in 2022 rolled back the constitutional right to have the procedure. That has driven a surge in medication abortion, which has spurred a series of legal battles over access to the drugs.

While Louisiana is challenging the 2023 rule, five other Republican-led states are pursuing broader lawsuits over regulations related to mifepristone, including the FDA's initial approval of the drug in 2000.

GenBioPro and Danco have intervened in one of those cases, brought by Missouri, Kansas, and Idaho. GenBioPro in 2023 also sued West Virginia, claiming that FDA regulations on mifepristone preempted the state's abortion ban. The Virginia-based 4th U.S. Circuit Court of Appeals rejected those claims last year.

Louisiana and Texas have also sued or indicted healthcare providers from other states for prescribing mifepristone to their residents, testing so-called "shield laws" in states including New York and California that protect providers against out-of-state investigations and prosecutions.

The case is Louisiana v. FDA, U.S. District Court for the Western District of Louisiana, No. 6:25-cv-01491.

For Louisiana: Caitlin Huettemann and others from the Louisiana Attorney General's office; Erin Hawley and others from Alliance Defending Freedom

For FDA: Noah Katzen and Brett Shumate of the U.S. Department of Justice

For GenBioPro: Robert Katerberg and others from Arnold & Porter Kaye Scholer; Skye Perryman and others from Democracy Forward; John Adcock of Adcock Law

For Danco: Jessica Ellsworth and others from Hogan Lovells; William Most of Most & Associates

Read more:

Texas sues Delaware nurse practitioner to test abortion 'shield law'

US abortion pill access under fire: Lawsuits and regulatory battles to watch in 2026

West Virginia abortion ban cannot block use of pills, GenBioPro tells court