The American Civil Liberties Union, ACLU, filed a lawsuit Thursday 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 most U.S. abortions. The lawsuit seeks to enforce the ACLU’s Freedom of Information Act, FOIA, request, filed in August, 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. The FDA has yet to respond to the ACLU’s FOIA request or to similar requests filed by other organizations, leaving the public in the dark about steps the agency appears to be taking toward making medication abortion harder to access.
“The people of this country deserve to know whether the Food and Drug Administration is following the science on medication abortion or simply following the whims of anti-abortion politicians and activists,” said Rachel Reeves, staff attorney with the Reproductive Freedom Project of the American Civil Liberties Union. “We demand transparency from the Trump administration and its anti-abortion allies, because this threat to our reproductive freedom cannot continue in secrecy.”
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 safety record of medication abortion. This paper — which is not peer reviewed and is only six pages long — has been denounced by more than 260 expert researchers for its lack of transparency and gravely flawed methodology.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 telemedicine to safely have a medication abortion after consulting with a health care provider and receiving their mifepristone prescription by mail from a provider or a pharmacy. If these politicians succeed, and the use of telemedicine for medication abortion is restricted nationwide, 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. As the Trump administration lays the groundwork to make mifepristone harder to access, a federal district court ruled in October in the ACLU’s longstanding case Purcell v. Kennedy that the FDA has failed to justify its current heavy restrictions on mifepristone, which already go far beyond what FDA imposes on the vast majority of medications. That recent decision prohibits the FDA from ignoring the wealth of peer-reviewed evidence on mifepristone’s safety and how the FDA’s restrictions burden patient access in conducting its new review.
