Judge pauses Louisiana chemical abortion case pending FDA review, allows nationwide distribution of pills to continue unregulated

A U.S. district judge on Tuesday halted proceedings in Louisiana’s lawsuit against the Food and Drug Administration over the national distribution of chemical abortion pills to give the FDA six months to report on the status of its “ongoing review.”

Despite the motion to stay the case, the judge also acknowledged Louisiana’s standing and injury.

“But the stay granted to FDA will not remain open-ended. FDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged,” Judge David C. Joseph of the Western District of Louisiana said in the court’s memorandum, adding that “the American public deserve nothing less.”

In a February hearing, Louisiana requested a preliminary injunction that would immediately re-instate previous protections for the prescription of mifepristone – the chemical abortion pill – including a required in-person doctor’s visit, which the FDA’s 2023 Risk Evaluation and Mitigation Strategies removed.

To obtain a preliminary injunction, plaintiffs must demonstrate they are likely to succeed in the case, they are suffering ongoing injury that outweighs possible harms from an injunction, and that an injunction would not harm public interest, Joseph explained in the court memo. He acknowledged, however, that Louisiana is likely to succeed in its lawsuit and that the state is suffering ongoing harm, including financial injury.

Louisiana can challenge the FDA because the 2023 REMS are “traceable” for causing “concrete and ongoing injury to Louisiana,” Joseph said, admitting that the change in policy directly targeted pro-life states.

“Thus, in that post-Dobbs regulatory environment, there is evidence that the 2023 REMS was approved without adequate consideration, at least in part, as part of an effort to circumvent anti-abortion states’ ability to regulate abortion,” Joseph wrote in the memo. “Likewise, there is evidence that the consequences of this action were predictable – out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana.”

However, Joseph ultimately denied Louisiana’s request for immediate relief, saying it would have a “nationwide effect,” adding that courts should not interfere in the FDA’s ongoing review of its policies.

“Ultimately it is FDA, not this Court, that possesses the expertise to evaluate scientific evidence and make public health judgments,” Joseph wrote.

“Put differently, at this juncture, it is the completion of FDA’s promised good faith, evidence-based, and expeditious review of the mifepristone REMS, not “government by lawsuit,” that this Court finds to be in the public interest,” he wrote.

But he also warned the court would “inevitably change” its stay if the FDA fails “to complete its review and make any necessary revisions to the REMS within a reasonable timeframe.”

Louisiana Attorney General Liz Murrill said she will appeal the ruling to the Fifth Circuit, according to Fox News.

“Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect,” Murrill said in a statement to Fox. “Accordingly, under binding Fifth Circuit precedent, the only thing left to do is vacate the 2023 REMS pending the outcome of this litigation. We will ask the Fifth Circuit to do so.”

Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said FDA’s ongoing study should not delay protections for women who are harmed from taking mifepristone.

“It is urgent that the FDA complete its promised safety study on these drugs, but this study also should not delay commonsense action: Deadly abortion drugs do not belong in the mail with no in-person doctor visit, no ultrasound, no meaningful medical oversight and no accountability,” she said in a statement.

Approximately 75% of emergency room visits for women who had taken mifepristone within 30 days were considered “severe or critical,” SBA reports. Additionally, more than 1 in 10 women who take mifepristone experience at least one serious adverse event such as hemorrhaging, infection, sepsis or even death.

“The administration’s choice to fight against survivors, the states, and their own base means they will be back in court to explain their timeline directly in the lead-up to midterm elections,” Dannenfelser said. “It would be far better to do what is right and bring back safety standards the majority of Americans support without being forced by the courts.”