FOIAengine: Hundreds of Requests Probing How FDA Weighs Risk and Responds to Warnings
A new tranche of just-released Freedom of Information Act requests from news organizations shows how reporters are using the act as an investigative tool to reconstruct internal decision making, trace outside influence, and test whether policy shifts were driven by evidence, pressure, or politics.
The media FOIA requests were released last week and posted to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows. Agencies targeted by reporters included the Food and Drug Administration, Federal Reserve, Departments of Energy and Transportation, and the Export-Import Bank.
In this week’s story, we’re highlighting some of the most trend-worthy media requests to the FDA. We’ll compile a roundup of the newest media requests to other agencies and departments in a future story. FOIAengine subscribers already have access to all 400 of the just-posted media FOIA requests.
The media requests to the FDA (through December, the most recent month available) span a wide range of subjects – from adverse-event case files and manufacturing inspections to senior officials’ calendars, ethics disclosures, and communications with politically active outside groups.
But the requests also share a common purpose: reconstructing how decisions were made, who influenced them, and whether warning signs were missed or ignored.
The filings reflect how journalists increasingly are turning to FOIA not merely to obtain isolated documents, but to map decision-making ecosystems: Who raised concerns internally? When did leadership become aware? Which outside actors had access? And how did those dynamics shape regulatory outcomes?
At the FDA, the most concentrated and consequential set of requests centered on drug safety surveillance and internal deliberations surrounding GLP-1 medications.
Desmond Butler, an investigative reporter for the Washington Post, filed multiple FOIA requests seeking communications between the FDA and the Centers for Disease Control and Prevention. A December 15 request sought internal briefing decks, attendee lists for safety meetings, and complete adverse-event case files related to “GLP-1 drugs and gastrointestinal motility injuries including gastroparesis, ileus, bowel obstruction, pseudo-obstruction, and aspiration during anesthesia from January 1, 2021 to the present.”
Butler’s requests targeted not just summary data, but the underlying case narratives and interagency exchanges that would reveal how regulators assessed emerging risks.
In all, Butler filed 26 FOIA requests with the FDA in December, 14 of which were requests for materials previously disclosed to others. Most requests dealt, in one way or another, with GLP-1 drugs. A separate December 15 request by Butler to the FDA sought “all agendas, attendee lists, and briefing decks prepared for FDA leadership meetings (including CDER [Center for Drug Evaluation and Research], OND [Office of New Drugs], OSE [Office of Surveillance and Epidemiology], and CDER Immediate Office leadership) that discuss GLP-1 drug safety, for the period January 1, 2022 to present.”
The timing of those requests is significant. GLP-1 drugs have become blockbuster therapies, with millions of patients using them for diabetes and weight loss, even as anecdotal reports of severe gastrointestinal complications have circulated widely. By pairing adverse-event data with calendars and briefing materials, Butler appears to be reconstructing a “who knew when” timeline – seeking to determine whether internal safety signals preceded public warnings or labeling changes, and whether regulators or manufacturers moved quickly enough once those signals emerged.
The New York Times also trained its FOIA lens on the FDA’s handling of safety reports. Christina Jewett, a longtime investigator of agency transparency issues, filed requests seeking records related to the FDA’s review, assessment, and conclusions for specific adverse-event reports, including those logged in the Vaccine Adverse Event Reporting System (VAERS) and the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS). Rather than requesting raw datasets, Jewett’s filings target the agency’s internal evaluative work – how staff analyzed individual reports, what follow-up occurred, and how final determinations were reached.
The significance of those requests lies in their focus on process rather than volume. Jewett’s reporting has repeatedly examined gaps between what safety databases contain and what the public can see about how regulators interpret and act on those signals. By seeking the FDA’s underlying analyses tied to specific report IDs, her requests probe whether serious complaints were reviewed consistently, whether conclusions were well-documented, and whether internal assessments aligned with public messaging.
Jewett’s bio on the Times’ website describes her FDA beat as the intersection of “political power, Wall Street pressures and public health protection. I’m interested in showing how the agency balances those forces and ultimately succeeds or fails in safeguarding the health of people in all corners of the country. It’s a busy beat.”
Another high-impact FDA request came from Bloomberg News reporter Gerry Smith, who sought FDA Center for Biologics Evaluation and Research analyses examining how many children died “after and because of” receiving Covid vaccines.
“I’m seeking all records related to an analysis by the FDA’s Center for Biologics Evaluation and Research about how many children died after and because of receiving Covid-19 vaccination,” Smith wrote. “This would include, but not be limited to, a December 5 post-marketing safety memo on this topic prepared by FDA scientists.”
Smith’s request targeted causality assessments rather than raw reporting numbers, an important distinction in vaccine safety debates.
FDA food safety and manufacturing oversight also drew sustained media attention. Phyllis Entis of eFoodAlert filed 13 FOIA requests with the FDA, including multiple requests seeking records from FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, which investigates and coordinates the federal response to foodborne illness outbreaks outbreak.
In her requests, Entis sought investigative files, inspection reports, environmental sampling data, and consumer complaints tied to infant formula manufacturer Abbott Laboratories; multiple other food-manufacturing facilities; and various salmonella outbreaks. The requests were highly specific, often referencing case-file identifiers and defined time windows.
Manufacturing compliance remained a persistent theme of the media requests. Requests from CNBC and the Houston Chronicle sought Form 483s, establishment inspection reports, and inspection summaries for pharmaceutical plants and compounding pharmacies.
Mike Williams, a reporter for Capitol Forum, continued to use FOIA requests to vacuum FDA inspection data about scores of companies. Williams filed 59 requests with the FDA during December.
Taken together, the latest media FOIA filings underscore how such requests have become an essential reporting tool for examining regulatory power in real time. Whether focused on drug safety, outbreak response, vaccine surveillance, or manufacturing oversight, the requests point to a broader effort by journalists to understand how federal agencies weigh risk and respond to warning signs. They also reflect growing scrutiny of how regulators balance public health responsibilities against political and commercial pressures. In that sense, the FOIA trail itself has become a map—revealing not just what agencies decide, but how those decisions take shape behind closed doors.
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Next: The latest hedge fund requests to the FDA.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. His next book, Summer of ’71: Five Months That Changed America, about the fateful year before Watergate, will be out in June. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.
