FDA sets March deadline for abortion pill safety review

The U.S. Food and Drug Administration expects to complete a sweeping safety review of the abortion pill mifepristone by March 2027, according to a new federal court filing in Louisiana, potentially setting the stage for restrictions on how the drug is prescribed and distributed nationwide.

The agency disclosed the timeline Wednesday in a status report submitted to U.S. District Judge David Joseph in Lafayette, where Louisiana Attorney General Liz Murrill is challenging federal regulations that allow abortion pills to be prescribed remotely and delivered through the mail.

The FDA expects to obtain results from a major safety study by mid-December, with a final report completed no later than March. Only then will the agency determine whether changes to its existing regulations are necessary.

The review could have significant consequences for abortion access across the country, particularly in states like Louisiana, where abortion is almost entirely prohibited but residents can still obtain medication from out-of-state providers.

According to the filing, the FDA is conducting a comparative safety study involving approximately 100,000 women who used mifepristone and another 100,000 women in a comparison group.

Researchers are examining the frequency of adverse health outcomes, including comparisons with surgical abortion, while accounting for differences between patients. The agency is also employing a statistical method known as TreeScan to identify potential safety concerns not previously detected.

The FDA said it has completed an initial feasibility assessment and is drawing on its Sentinel surveillance system, a network of health care databases, along with additional sources of information.

Beyond the safety study, regulators are considering petitions seeking changes to the drug's distribution rules, including reinstating a requirement that mifepristone be dispensed in person at certain medical facilities.

Those petitions collectively cite more than 170 articles and publications and have attracted hundreds of public comments, according to the filing.

Mifepristone, used alongside another medication called misoprostol, has been approved for abortion in the United States since 2000. The FDA has repeatedly concluded that the medication is safe and effective, with serious complications considered rare. The American College of Obstetricians and Gynecologists has similarly opposed restrictions it considers medically unnecessary.

In 2023, during then-President Joe Biden’s administration, the FDA removed the in-person dispensing requirement and allowed certified pharmacies to dispense mifepristone.

Those changes became a central target of Louisiana's legal challenge, which argues that the FDA failed to adequately evaluate the risks associated with removing the restrictions.

Joseph declined to immediately suspend the regulations in April, instead putting the lawsuit on hold while the federal government completed its review. Although he concluded that Louisiana was likely to succeed in its challenge, the judge determined that allowing the FDA to finish its work would better serve the public interest.

Louisiana appealed, and the 5th U.S. Circuit Court of Appeals ordered the 2023 regulations suspended in May. However, the U.S. Supreme Court subsequently blocked that decision, preserving access to mail-order mifepristone while the litigation continues.

The legal dispute has become part of a broader effort by Republican-led states to restrict abortion medications crossing state lines.

Louisiana, Alabama and Arkansas have also pursued legal challenges against out-of-state abortion providers, arguing that shipping the medications into states with abortion bans violates their laws.