FOIAengine: Growing Scrutiny of Drug Safety and Enforcement
As GLP-1 weight-loss drugs surge in popularity, major news organizations are pressing the Food and Drug Administration for internal records that reveal what regulators knew about reports of dangers associated with the popular drugs, when they knew it, and how they responded – amid growing media scrutiny of drug safety and enforcement gaps.
A new set of news-media FOIA filings reviewed by FOIAengine highlights several pressure points inside the agency. The November media requests, just posted, include multiple Washington Post requests seeking internal FDA analyses and safety discussions related to intestinal obstruction risks linked to GLP-1 drugs, as well as inspection and compliance records tied to the U.S. operations of the other GLP-1 maker, Denmark’s Novo Nordisk.
The media requests we’re highlighting are significant because they represent investigations in progress – stories still in the pipeline, which means the targets of the requests have an early warning of possible negative publicity to come. We’ll break down everything below.
In addition the noteworthy Washington Post requests, other media FOIA requests to the FDA this month came from, among others, the Houston Chronicle and ProPublica.
The Houston Chronicle requests sought adverse-event reports and enforcement records involving the compounding giant Empower Pharmacy, and came from an investigative journalist whose reporting has focused on the compounder. Meanwhile, ProPublica pushed for FDA inspection reports on infant-formula maker ByHeart in the wake of a widening late-2025 botulism outbreak and nationwide recall. The ProPublica request appeared to focus on possible laxity of FDA’s oversight as the outbreak began.
The above requests were among 125 filed with the FDA by reporters in November and posted to FOIAengine this week. They offer a snapshot of how journalists are using public-records law to interrogate the agency’s most consequential regulatory decisions – often months or years before those decisions are tested in courtrooms, congressional hearings, or financial markets.
Taken together, the media requests point to a broader focus on how FDA oversight functions in moments of stress – when blockbuster drugs strain manufacturing and monitoring systems, compounding pharmacies step into regulatory gray zones, and food safety failures escalate into public-health emergencies. Each set of filings seeks records that could clarify whether warning signs were identified early; how aggressively regulators acted; and whether enforcement tools were used consistently across industries.
Also, amid the media requests, Capitol Forum continued its industrial-scale FDA surveillance, filing 80 separate FOIA requests in November, largely aimed at harvesting Form 483s, Establishment Inspection Reports (EIRs), and inspection logs across the food, pharmaceutical, device, and compounding sectors.
As we’ve previously reported, the Capitol Forum requests – usually naming a specific manufacturing site and often repeated across multiple locations owned by the same company – reflect an ongoing, systematic effort to surface compliance failures, quality-control breakdowns, and enforcement-risk signals that can feed litigation analysis, investment research, and follow-on reporting. (See our December 10 article, “How Capitol Forum Sweeps Up FOIA Data”.)
Here’s what we know about the important FDA media requests just posted. Subscribers can log in to FOIAengine to see everything:
Desmond Butler of the Washington Post requested access to “(1) All records associated with FDAs New or Ongoing Safety Signal (NISS) 4823 concerning ileus/intestinal obstruction and the class of glucagon-like peptide-1 receptor agonists (GLP-1 RAs). (2) All updates, assessments, and internal analyses: – interim or periodic safety signal assessments. (3) Communications related to NISS 4823: – emails (including attachments) among staff. (4) All versions (draft and final) of documents supporting the November 1, 2022 FDA pharmacovigilance review titled: Intestinal Obstruction Associated with GLP-1 Receptor Agonists. (5) Records reflecting internal safety signal tracking: – spreadsheets, tracking logs, or monitoring tables.”
In a separate request, Butler also sought “release of all data, analysis files, drafts and internal materials supporting FDA Nov. 1, 2022 pharmacovigilance review [regarding] Intestinal Obstruction Associated with GLP-1 Receptor Agonists.” A third request by Butler, filed on November 25, the same day as the other two, specifically sought Novo Nordisk’s GLP-1 “full inspection package.”
Butler’s requests indicate the Post is taking a closer look at one of the known risks associated with GLP-1 drugs, and whether the FDA responded sufficiently. As early as 2020, the FDA required the drug makers to place a warning label about such risks. But by mid-2023, with at least 20 deaths attributed to GLP-related intestinal blockages, the FDA began stepping up labeling requirements.
Julian Gill, an investigative reporter for the Houston Chronicle sought “all FAERS case reports for adverse events associated with compounded ketamine, sermorelin, nandrolone and nicotinamide adenine dinucleotide (NAD+). Please note I am asking only for case reports associated with the compounded products – not commercial versions.” The request was one of four last month from Gill referencing Empower.
FAERS is the FDA’s national database for collecting information about suspected adverse events and medication errors involving drugs and biologics marketed in the United States.
In addition to ketamine, Gill’s request focused on various compounds that are marketed as anti-aging hormones. His request indicates that he isn’t done investigating Houston-based compounding giant Empower. Gill’s previous reporting on Empower include a story last May titled “Empower Pharmacy says it sells ‘quality’ compounded drugs. 10 years of FDA violations raise doubts.”
Annie Waldman of ProPublica sought “a copy of the Establishment Inspection Report (EIR) connected to the December 21, 2022, through February 17, 2023 inspection of ByHeart, Inc. (see: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-653854-08302023). FEI Number: 3022729623, Inspection end date: 2023-02-17, Product type: Infant Formula.”
The link that Waldman included in her request mapped back to a 2023 infant-formula inspection warning letter that the FDA sent to ByHeart. Waldman’s November 11 FOIA request to the FDA came as the FDA announced an investigation and recall of ByHeart’s infant formula, suspected in an outbreak of potentially life-threatening infant botulism. ProPublica’s FOIA query indicates the reporter is testing whether there is a connection between the two.
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Next: Hedge fund requests to the Food and Drug Administration.
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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 next year. 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.
