Drugmakers ask to intervene in Louisiana lawsuit against mailing abortion drugs

Two drug manufacturers asked a federal judge Tuesday if they can intervene in a Louisiana-led lawsuit seeking to stop a key abortion drug from being mailed to patients.

The filings come less than a week after the Trump administration sought to pause the case until the Food and Drug Administration completes a review of mifepristone, an abortion drug much research has shown is safe and effective in terminating early pregnancies.

Health and Human Services Secretary Robert F. Kennedy Jr. ordered a review of mifepristone regulations in May after he said findings from a non-peer reviewed paper published by an anti-abortion think tank were “alarming,” States Newsroom reported.

The FDA launched the review in September, but Kennedy and FDA Commissioner Marty Makary are facing scrutiny from both abortion-rights opponents and supporters about the timeline.

Unlike the federal government, GenBioPro, mifepristone’s generic manufacturer, and Danco, which makes the brand name version, would ask the court to dismiss Louisiana’s case entirely.

“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. “We will not stand by while politically-motivated efforts put Americans’ access to medication abortion in jeopardy.”

A recent analysis of evidence the FDA used during a 12-year period to evaluate mifepristone’s framework determined that regulatory changes were based on science and caution.

The drugmakers are represented by different law firms but filed motions to intervene on the same day.

Lawyers for GenBioPro wrote that the lawsuit “directly and concretely threatens” the manufacturer’s interests — mifepristone makes up a majority of its revenue, and a “significant portion” of sales come from telehealth prescriptions, according to court documents.

Louisiana asked the court for a preliminary injunction in December that would immediately halt a 2023 regulatory change that allows mifepristone to be sent through the mail.

“Without the in-person dispensing requirement, prescribers and pharmacies can now dispense mifepristone by mail or in-person, making it available and accessible to many more patients,” GenBioPro’s lawyers wrote.

They also argued the federal government under Trump doesn’t adequately represent its interests: GenBioPro’s main goal is to defend the regulatory modification approved during the Biden administration.

Lawyers for Danco, which produces Mifeprex, agreed with Department of Justice lawyers who argued that the defendants lack standing to sue in the first place. But they argued “the more prudent course is to dismiss the action” instead of stalling court proceedings.

A hearing in the case is set for  Feb. 24.