ACLU sues FDA over unanswered Freedom of Information Act request
The American Civil Liberties Union (ACLU) filed a lawsuit last week, seeking to compel the U.S. Food and Drug Administration (FDA) to be transparent about its upcoming review of policies surrounding the prescribing and distribution of the abortion pill mifepristone. The ACLU is asking a court to force the agency to hand over records and internal communications as part of a Freedom of Information Act (FOIA) request made in August.
The ACLU said in an announcement that the FDA has yet to respond. Further, it said other organizations have made similar requests that have also gone unanswered. The civil libertarian nonprofit said the silence is “leaving the public in the dark about steps the agency appears to be taking towards making medication abortion harder to access.”
Currently, it’s not against the law for the medication to be prescribed via telemedicine and mailed over state lines—though there are pending cases in Texas and Louisiana challenging states’ rights and asking federal regulators to intervene. In the latter case, the state has actually charged a doctor in California with a criminal offense and issued an arrest warrant.
The FOIA requests are an attempt to shed light on where the FDA stands on the issue, to better prepare for any final rules on policy they may issue that restrict access to mifepristone or similar drugs.
Named in the request are also any communications between agency officials and anti-abortion groups, state regulators, federal authorities and politicians seeking insight or offering feedback on the topic.
“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,” Rachel Reeves, staff attorney with the Reproductive Freedom Project of the ACLU, said in a statement. “We demand transparency from the Trump administration and its anti-abortion allies, because this threat to our reproductive freedom cannot continue in secrecy.”
The FDA is expected to release a formal review on the use of medications for early term pregnancy termination imminently, which the ACLU said it fears will be based on a “deeply flawed paper” written by the conservative political advocacy group Project 2025—which the ACLU said has been cited by FDA Commissioner Marty Makary, MD, as a source for the agency’s internal analysis.
“This paper—which is not peer reviewed and is only six pages long—has been denounced by more than 260 expert researchers for its lack of transparency and gravely flawed methodology,” the ACLU added.
It remains to be seen what the FDA will ultimately say on the topic, and if any report will have real-world consequences. Notably, the civil lawsuit in Texas over the legality of sending abortion-related medications through the mail, is centered around the Comstock Act of 1873.
The old law bans the sending of obscene material through the U.S. Postal Service, including content related to abortion. It’s a novel idea to interpret the law as barring prescriptions, given the recency of the overturn of Roe v. Wade.
All of the above cases are still pending an outcome in court.
Request complicated by staff shortages and shutdown
It’s unclear how the recent shutdown of the federal government impacted FOIA responses. But given that thousands of staff at agencies of the Department of Health and Human Services—including the FDA—were furloughed for 43 days, it's possible the FDA intended to reply but didn’t have the manpower.
Something similar happened in May when the FDA was forced to rehire workers fired by Elon Musk’s “DOGE” (Department of Government Efficiency) initiative after a federal judge ruled that the agency was too slow in fulfilling FOIA requests.
The ACLU filed the new lawsuit Nov. 14.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.