ACLU v. U.S. Food and Drug Administration
What's at Stake
The ÀÏÊìÅ®ÎçÒ¹¸£Àû (ACLU) filed a lawsuit to compel the Food and Drug Administration (FDA) to disclose records related to the agency’s review of its regulations on mifepristone, a medication used in U.S. abortions. The lawsuit seeks to enforce the ACLU’s Freedom of Information Act (FOIA) request, filed in August 2025, which seeks information about the scope of the review along with any communications between the FDA and anti-abortion organizations, state and federal officials, and politicians requesting greater restrictions on medication abortion.
Summary
In May 2025, the Trump administration announced that the FDA is conducting a new review of its mifepristone regulations. Alarming statements from Trump administration officials, including FDA Commissioner Marty Makary, have indicated that the review centers upon a deeply flawed paper, written by a Project 2025 cosponsor, that purposefully distorts the excellent safety record of medication abortion. This paper — which is not peer reviewed and is only six pages long — has been for its lack of transparency and gravely flawed methodology.
Anti-abortion politicians are nevertheless using this paper to push for medically unnecessary restrictions, including limits on telemedicine for abortion. Today, 1 in 4 U.S. abortion patients use to safely have a medication abortion after consulting with a health care provider access to abortion will be further out of reach for patients across the nation.
The FOIA request and complaint are just the latest in the ACLU’s efforts to protect and expand access to medication abortion.
Legal Documents
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11/13/2025
Complaint
Date Filed: 11/13/2025
Court: District Court (D. Md.)
Affiliate: Maryland
Press Releases
ACLU Files Lawsuit to Demand Transparency from the FDA in Its Review of Medication Abortion Regulations