A federal judge in Louisiana ruled that the Food and Drug Administration must provide a status report on its safety review of the abortion pill within six months.
The judge also found that a challenge to the policy of allowing abortion pills to be shipped through the mail has standing and is likely to succeed on the merits.
“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,” District Judge David C. Joseph wrote. “The parties and the American public deserve nothing less.”
The state of Louisiana filed the lawsuit against the administration, challenging the Biden-era policy of allowing abortion drugs to be sent through the mail, including into states where abortion is illegal.
Louisiana Attorney General Liz Murrill and Alliance Defending Freedom filed the lawsuit on behalf of Rosalie Markezich, a Louisiana resident whose boyfriend ordered abortion pills from California and drugged her against her will, leading to the loss of her unborn baby.
Murrill argued that the ruling means Louisiana is likely to succeed in showing the danger posed by the lack of safeguards on the abortion pill.
“He [Judge Joseph] also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect,” Murrill said, referring to the Biden administration’s loosening of safeguards.
“Accordingly, under binding 5th Circuit precedent, the only thing left to do is vacate the 2023 REMS pending the outcome of this litigation. We will ask the 5th Circuit to do so.”
Pro-life groups have criticized FDA Commissioner Marty Makary for “slow walking the abortion pill review.” Makary has responded that the administration is “engaging in a robust study” of the effects of abortion pills on women’s health.
“We hope to see justice delivered swiftly for countless women like Rosalie, coerced into abortions they didn’t want because their abusive partners were able to order abortion drugs online,” Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said.
“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.”
Joseph said the case must be paused to give FDA time to finish the review, but the pause will be revisited if the FDA doesn’t act within a “reasonable timeframe.” The court ordered the FDA to provide a status update on the review within six months.
“Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change,” he continued.
The FDA requested a stay until the safety review is complete. The agency has not given a clear update on the status of the study.
The court found that the harm to Markezich by abortion pills was directly caused by the lack of safeguards.
“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,” Joseph wrote.
Alliance Defending Freedom President Kristen Waggoner said she is grateful that the court determined Louisiana is likely to win on the merits, but disappointed that the court granted FDA’s request to stay the case.
“ADF Legal is grateful for the significant wins on standing and the merits of our case,” she said. “But with women’s health and babies’ lives at stake, we are disappointed by the delay in accountability.”
