FDA says it will complete safety review of abortion pill in March

The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.

In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said.

Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.

The FDA approved mifepristone in 2000, and hundreds of peer-reviewed studies have found it to be safe and effective.

The FDA temporarily eliminated a requirement to dispense mifepristone in person in 2021, then finalized the change in 2023. It said Wednesday that it plans to re-evaluate that decision based on the new data it collects. It may weigh the views of patients, providers and pharmacists, as well as additional studies it did not consider in 2023.

The review’s expected completion date falls months after the Nov. 3 midterm elections — when abortion access is among the concerns for voters.

The update…

Original source: https://www.nbcnews.com/health