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ACLU Sues FDA to Obtain Records on Mifepristone Review

The filing seeks documentation to determine whether the agency’s scrutiny of the abortion pill was grounded in scientific evidence.

Overview

  • The ACLU filed a Freedom of Information Act lawsuit seeking records on the FDA’s internal review of mifepristone.
  • The action follows a separate FOIA lawsuit filed in September by the Center for Reproductive Rights over the same records.
  • Litigants say the FDA has not produced documents or responded to FOIA requests that would show what the agency reviewed.
  • The scrutiny followed a non–peer‑reviewed analysis from the Ethics and Public Policy Center alleging adverse effects, which was denounced by more than 200 experts and promoted by Sen. Josh Hawley and anti‑abortion state attorneys general.
  • Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have said the agency conducted the review, while mifepristone remains widely used, accounting for roughly one in four U.S. abortions in 2023.