FDA tells Louisiana court mifepristone safety review will finish by March 2027

Left · 2The Food and Drug Administration told a federal court in a filing on Wednesday that it expects to complete its safety review of the abortion pill mifepristone in March. 1 2 Left · 2The filing responded to an order from a federal judge in Louisiana, who is hearing a state lawsuit that challenges mail and telehealth delivery of the drug and who asked for a progress report. 1 2 Left · 2The FDA said it expects results of the study in mid-December and will then analyse the data and draft a final report. After that, it will decide whether to impose new restrictions or other changes. 1 2

Left · 1According to NBC News, the review will compare mifepristone's safety with that of surgical abortions through 10 weeks' gestation and measure the frequency of side effects among roughly 100,000 women who took the drug. 1 Left · 1CBS News reports that the FDA said it is using a "statistical data mining method" on an electronic database of reports from major health networks and insurers to look for "unknown safety concerns", and that it is also weighing petitions to change how the drug is prescribed and distributed. 2 Left · 2The FDA also said it plans to re-evaluate its decision to drop the in-person dispensing requirement, which it suspended in 2021 and finalised in 2023. It may weigh the views of patients, providers and pharmacists, as well as studies it did not consider in 2023. 1 2

Left · 2The FDA approved mifepristone in 2000 and has repeatedly reaffirmed its safety and effectiveness. NBC News says hundreds of peer-reviewed studies have found it safe and effective, and that less than 0.5% of women who take it have serious adverse reactions. 1 2 Left · 1Health Secretary Robert F. Kennedy Jr. commissioned the review last year after a conservative think tank claimed to have found a higher rate of serious complications than the FDA reported. Researchers who study reproductive health told NBC News the think tank's findings, which were not peer-reviewed, amounted to junk science. 1 Left · 1Abortion opponents criticised the timeline. Gavin Oxley of Americans United for Life said the administration "continues to find itself on the wrong side of women's health" and lacks "true leadership". 2

Left · 2The Louisiana case sits among several state suits over the drug. In May a federal appeals court reinstated a nationwide in-person dispensing requirement, but the Supreme Court quickly blocked that decision while the case continues. Last month a 5th Circuit panel questioned the merits of Louisiana's case, including its legal standing. 1 2 Left · 1NBC News notes that the completion date falls months after the Nov. 3 midterm elections. It also says the FDA lacks a permanent commissioner and that Trump's nominee, Dr. Heidi Overton, who has called medication abortion "dangerous to women", sidestepped questions about mifepristone's safety at her confirmation hearing. It is unclear what conclusion the review will reach. 1