The FDA has confirmed its safety review of mifepristone — the nation's most widely used abortion pill — will extend into next year, with a final report expected no later than March 2027. The review, ordered by Health Secretary Robert F. Kennedy Jr., was disclosed in a court filing in a Louisiana federal lawsuit challenging the drug's mail-order prescribing rules. A safety study comparing 100,000 mifepristone users to a surgical abortion comparator group is expected to conclude by mid-December 2026.

The review could open the door to significant access restrictions. On the table: reinstating an in-person dispensing requirement scrapped in 2023, and potentially revisiting the FDA's original 2000 approval of the drug — though the latter would be a lengthy and complex process. The FDA is also weighing multiple petitions pushing for tighter controls on how the drug is prescribed and distributed.

By the Numbers:

• 65% of US abortions in 2023 were medication abortions (Guttmacher Institute)
• 100,000 mifepristone users being analyzed in the FDA's safety study
• Mifepristone has been FDA-approved since 2000, with its safety reaffirmed multiple times since

Why it matters: Major medical organizations have consistently backed mifepristone's safety profile, but the review's outcome could reshape abortion access across the country — especially in states where mail-order prescribing has served as a workaround to local bans.