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 Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.

The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.

In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.

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Health Secretary Robert F. Kennedy Jr. commissioned the safety review last year after a conservative think tank claimed to have found a higher rate of serious complications from mifepristone than the FDA reported. Several top Republicans, including Sen. Bill Cassidy of Louisiana, have also pressured the Trump administration to tighten access to the drug.

Researchers who study reproductive health said the think tank’s findings, which were neither peer-reviewed nor published in a medical journal, amounted to junk science. A wealth of data has shown that less than 0.5% of women who take mifepristone have serious adverse reactions.

It’s unclear what conclusion the FDA, which lacks a permanent commissioner, will draw from its new study.

President Donald Trump’s pick to lead the FDA, Dr. Heidi Overton, a White House adviser, is a fierce opponent of abortion rights, having previously described medication abortion as “dangerous to women.”

At her Senate confirmation hearing last month, Overton repeatedly sidestepped questions about mifepristone, including whether she believes the abortion pill is safe.