FOIAengine: Insights From the Latest FDA and SEC Requests
News media outlets are among the most prolific submitters of FOIA requests to federal agencies. These requests signal – in real time – the stories that journalists are researching and writing. To illustrate this point, we’re summarizing highlights of the hundreds of FOIA requests submitted by media organizations to the Food and Drug Administration and the Securities and Exchange Commission during March (the most recent month for which information is available).
News Media FOIA Requests to the FDA
Members of the news media submitted 97 FOIA requests to the FDA last month, addressing a range of hot-button issues, including FDA review of Alzheimer’s drugs lecanemab and donanemab; the existence of counterfeit weight loss drugs; information about pharmacies in Pennsylvania providing mifepristone; pharmaceutical manufacturing facilities in India; the use of remdesivir for the treatment of Covid-19; and the Wanabana recall of lead-tainted pouches of apple puree and applesauce. See our March 13 article on Wanabana.
The following are selected excerpts of these FOIA requests.
The New York Times submitted eight FOIA requests to the FDA during March. Of particular interest were three requests that sought information about brain atrophy and shrinkage in connection with Alzheimer’s drugs produced by Biogen (lecanemab) and Eli Lilly (donanemab).
A first request was for “all correspondence … between FDA agency staff and Esai Inc. or Biogen personnel regarding its drug, lecanemab (Leqembi) that contain any of the following case-insensitive key-words: “brain atrophy,” or “brain shrinkage,” or “brain volume.” A second request sought “all correspondence between FDA agency staff and Eli Lilly personnel regarding its drug, donanemab, that contain any of the following case-insensitive key-words: “brain atrophy,” or “brain shrinkage,” or “brain volume.” A third request was for “all correspondence … between FDA agency staff and Esai Inc. personnel that contains the following case-insensitive key-words: “demand generation.”
These requests relate to a review of MRI data from drug clinical trials concluding that these Alzheimer’s drugs have the potential to compromise long-term brain health by accelerating brain atrophy. Lecanemab was approved last year, but in early March of this year the FDA delayed a decision on whether it will approve donanemab, Eli Lilly’s closely watched new Alzheimer’s drug.
The FDA informed Eli Lilly it was planning to convene an advisory committee to further assess donanemab’s safety and efficacy. While Eli Lilly noted in its announcement that the delay does not result in a change in the company’s 2024 financial guidance, its stock price has declined almost six percent since the announcement.
Other New York Times FOIA requests sought “all correspondence … between FDA and Eli Lilly and Company personnel regarding the Phase 1 trial of Remternetug that began November 2018 and was terminated in April 2019;” a request for a 483 plant inspection report about “an inspection of the Cord Blood Registry, a firm owned by CooperSurgical and located in Tucson, Arizona;” and “all correspondence to/from Acella Pharmaceuticals, or to/from Alora Pharmaceuticals related to thyroid medications.”
Reuters made six requests relating to weight-loss drugs. The requests asked for documentation regarding adverse events related to semaglutide (the active ingredient in weight loss drugs Wegovy, Ozempic and Rybelsus); a specific adverse event related to tirzepatide (the active ingredient in weight loss drugs Zepbound and Mounjaro); “the latest correspondence sent by the FDA to the National Association of Boards of Pharmacy warning them about counterfeit/fake Ozempic/Wegovy/semaglutide;” the “latest correspondence sent by the FDA to the Healthcare Distribution Alliance related to counterfeit Ozempic/ Wegovy/semaglutide;” “the orange alert related to counterfeit Ozempic that was sent by Interpol to the FDA this year;” and “the Europol Operation SHIELD IV full report that was sent to the FDA this year.”
Belgium’s VTM Nieuws also submitted a request for a report to the FDA regarding “fake Ozempic.”
The Associated Press requested “copies of FDA’s annual list of registered drug facilities, foreign and domestic, for each of the last 10 years.”
Bloomberg requested “[e]mails, text messages, letters, memos, mentioning or referring to GLP-1 drugs received from or sent to Kellogg Co., Kellanova, PepsiCo, Coca-Cola Co., Mondelez International, Kraft Heinz Co., JM Smucker Co., Campbell Soup Co., Tyson Foods Inc., Nestle SA, Hormel Foods Corp (“the Companies”); or the Consumer Brand Association, the North American Meat Institute, and the National Milk Producers Federation.”
Bloomberg News requested “the FDA form 483 inspection report of the most recent inspection of Brassica Pharma’s facility in Maharashtra, India;” “full inspection reports for Huntington Reproductive Center Medical Group;” and “correspondence including calendar entries and emails discussing, scheduling or planning meetings between [specified] FDA officials … and Amylyx Pharmaceuticals between March 2024 and May 2024.”
CBS News submitted five FOIA requests seeking information about, among others, Brassica Pharma Private Ltd. and Emergent Biosolutions LLC, along with correspondence between the FDA and Dollar Tree, Family Dollar, or Ecuador’s ARCSA regarding the Wanabana USA recall that was terminated on March 4.
FDA News submitted 13 FOIA requests for copies of Form 483 inspection reports issued during October and November 2023 regarding several device and drug companies, the names of which were not included in the FDA request summary.
TheFinancial Times submitted two requests for the “rolling average headcount of permanent FDA India office staff” broken down on a quarterly calendar basis from January 2019 to end of December 2023” and the “[r]olling average headcount of permanent FDA staff based in India broken down on a yearly calendar basis from Jan. 1 2013 to Dec. 31 2023.”
Kaiser Health News submitted a request for “copies of documents specifically citing the drug remdesivir for the treatment of Covid-19.”
Politico submitted three detailed requests seeking “copies of all records of electronic communications” among a list of FDA officials that refer to Florida, Canada, the Florida state government, or the Colorado state government.
ProPublica requested “any and all surveillance and for-cause inspection reports from 01/01/14 to 03/01/24 for two Michigan water bottling facilities:” BlueTriton (formerly Nestle) water bottling plant for Ice Mountain spring water of Stanwood, Michigan, and Absopure Water Company of Plymouth, Michigan.
Elena Kadvany of the San Francisco Chronicle requested “any complaints, inspection records, investigations, determinations, penalties and/other documents related to food safety and/or mislabeled seafood at a specific business: Tadich Grill in San Francisco.”
The Washington Post requested all reports and data used in determining the DEA aggregate production quota for oxycodone for the years 2009, 2012 and 2013.
USA Today Network requested a “list of pharmacy names and locations in Pennsylvania that have received FDA certification to dispense mifepristone, as well as the date each pharmacy was certified.”
News Media FOIA Requests to the SEC
News media FOIA requests to the SEC during March indicated that reporters were working on stories related to OpenAI and Microsoft, Bitcoin, Russian sanctions, Trump Media, BlackRock, Berone Capital, Medical Properties Trust, and Cinemark.
Among the news media requests to the SEC:
Max Cherney of Thomson Reuters submitted 3 requests on March 4 seeking “[c]orrespondence sent to and/or received by the registrant, and/or received by third parties on behalf of the registrants OpenAI Inc., OpenAI Global LLC, and Microsoft.”
Matthew Goldstein of The New York Times requested on March 28 “the exhibits submitted to two comment letters from Trump Media & Technology Group (formerly Digital World) on Aug, 22, 2022 and Aug. 24, 2022.”
MuckRock News requested on March 20 “any summary statistics or reports available on Russian securities traded on US exchanges before Russian sanctions began in February 2022.”
Bloomberg requested on March 6 “the number of insider trading leads FINRA [Financial Industry Regulatory Authority] referred to the SEC each year from 2019 through 2023.”
Leo Schwartz of Fortune submitted two requests on March 26. The first asked for “emails or other communications between representatives of BlackRock and staff, Commissioners, or the Chair of the SEC relating to the IBIT iShares Bitcoin ETF from December 1, 2023 to January 31, 2024.” The second sought “electronic copies of emails and their attachments sent by and to staff members in the U.S. Securities and Exchange Commission’s Office of Public Affairs between January 9, 2024 and March 26, 2024 concerning the Jan 9, 2024 compromise of the X social media account @SECGov and erroneous posts on the purported approval of Bitcoin exchange-traded products.”
Jason Leopold of Bloomberg News requested on March 25, the “final reports of investigation and final audits that have not been publicly disclosed or posted to a FOIA reading room concerning investigations and audits closed in 2023 and 2024 thus far.”
Leslie Tan of CBS requested on March 2 “all information regarding Cinemark, Inc.”
Lucas Nathan of the Albany Business Review requested on February 15 “investigation records of Berone Capital LLC from January 1, 2023 to present.”
Alexandra Garfinkle of Fortune requested on March 4 “all investigative records concerning Alumni Ventures Group, from 2020 to present.”
Jonathan Weil of The Wall Street Journal submitted a request on March 5 requesting “all comment letters and response letters referred to in “Item 1B. Unresolved Staff Comments” in the Form 10-K for the year ended Dec. 31, 2023, filed by Medical Properties Trust (MPT),” along with a request on March 6 asking for “10A letters since Jan 1, 1996: All SEC records showing how many 10A letters were received annually by the SEC for each year.”
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Next from FOIAengine: What does the American Accountability Foundation want to know – and why?
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Learn more about FOIAengine here. Sign up here to become a trial user of FOIAengine.
Write to Randy E. Miller at [email protected].
