FOIAengine: Law Firm’s 48 Inquiries Follow Earlier Requests
Personal injury law firm Morgan & Morgan continued to push the Food and Drug Administration during May for documents that could strengthen potential litigation challenging popular weight control drugs.
The 48 Freedom of Information Act requests from Morgan & Morgan were among the 856 total requests submitted to the FDA in May, as compiled by PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
Morgan & Morgan’s FOIA requests sought specific Adverse Event Reports concerning FDA-regulated weight control medications, including Ozempic (semaglutide), Rybelsus (semaglutide), Wegovy (semaglutide), Mounjaro (tirzepatide), Trulicity (dulaglutide), Saxenda (liraglutide), and Zepbound (tirzepatide).
An FDA Adverse Event Report (FAERS) describes adverse reactions and medication error reports associated with the use of drug or biologic products.
The Morgan & Morgan requests are noteworthy because they follow five similar requests made by the firm on October 12, 2023, seeking information about the FDA’s consideration of drug applications for Rybelsus, Mounjaro, Wegovy, and Ozempic. See our November 16, 2023, report on Morgan & Morgan’s possible litigation preparations.
Other FDA May FOIA Requests
Among other notable requests to the FDA during May were three requests from plaintiffs law firm Siri & Glimstad for information about all meetings in 2022 and 2023 of the Vaccines and Related Biological Products Advisory Committee; a case report regarding the Pfizer COVID-19 “vaccine clinical trial for adolescents ages 12-15;” and all records from 2015 to July 1, 2020 “that contain the search term(s) ‘Big Bad Cough’ OR (world AND ‘GSK’) or (‘GSK’ and unbranded).” See our January 25 article on Siri & Glimstad’s plans to seek an end-around the federal law inoculating the Big Three vaccine makers from Covid-vaccine lawsuits.
An unidentified reporter or reporters at the New York Times submitted to the FDA a number of requests in May. Two May 14 requests were for information about “any ethics agreement regarding Dr. Jeffrey Shuren” and “any record showing a recusal or a waiver issued under ethics laws for Dr. Jeffrey Shuren.” Shuren, the longtime head of the FDA’s Center for Devices and Radiological Health, has been in the Times’ investigative sights for at least a year. See our July 20, 2023, article discussing a June 1, 2023, New York Times request for “a document that contains a review of Dr. Jeffrey Shuren’s potential conflicts and/or a description of when or how he will recuse himself from decision making related to his wife, Allison Shuren, who co-chairs the Life Sciences and Healthcare Regulatory practice at the firm Arnold & Porter.”
New York Times requests to the FDA in May also included requests for a Form 483 inspection report and an Establishment Inspection Report on May 13 and May 17 for CBR Systems Inc. in Tucson, AZ; an inspection report for medical device manufacturer CooperSurgical in North Tonawanda, NY; any 483 reports or correspondence regarding Cryo-Cell International in Oldsmar, Florida; a series of specific Adverse Event Reports; “483 inspection reports and specific Establishment Inspection Reports for LifeSouth Community Blood Centers, Inc. located in Gainesville, FL from 2020, 2017 and 2014; an EIS and Form 483 inspection report for Bloodworks in Seattle, WA, in 2017 and 2019; and a Form 483 inspection report for inspections in 2017 and 2020 for the New York Blood Center Enterprises in Long Island City, NY.”
Form 483 reports are issued by FDA inspectors to firms at the conclusion of an inspection that has found indications that a drug has been or may become adulterated or injurious to health.
Financial firm Point 72 submitted six requests seeking Adverse Event and Form 483 reports for companies Lonza Biologics, Inc. of Portsmouth, NH, and Cipla Ltd., and for the drugs Syfovre, Izervay, Ogsiveo (nirogacestat), Veozah (fezolinetant), and Winrevair (sotatercept).
BofA Securities requested a Form 483 inspection report for a Zydus Lifesciences plant in India.
Darsana Capital Partners requested “data on the last 300 new 510(k) medical devices approved. Specifically, we would just like to know what sterilization modality these devices have tested and have approval for (i.e. Ethylene Oxide, Gamma, e-beam, x-ray, VHP, etc.).” A 510(k) is “a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.”
English Capital requested Adverse Event Reports relating to the drug Daybue (trofinetide).
RBC Capital Markets requested Adverse Event Reports regarding Skyclarys (Omaveloxolone).
SEC May FOIA Requests
At the SEC, financial firm Verdis Investment Management submitted 14 requests for information about a number of officials at Carmel Partners in San Francisco, CA, venture capital firm Scribble Ventures (SV III GP) in Portola Valley, CA, and CurieBio LLC.
The American Securities Association submitted to the SEC a request for “all records (including, but not limited to, emails and memoranda) discussing how any penalties, fines, or other sanctions associated with the SEC’s recent recordkeeping sweep initiative were calculated, determined, proposed, or agreed to. This request includes any records comparing penalties, fines, or other sanctions across the industry or among individual entities or individuals.” The request from the ASA, which mainly represents smaller and regional brokerages, may indicate that the association is taking a more aggressive advocacy stance with the commission. The ASA submitted six requests on March 14 that also sought documents related to the SEC’s “recordkeeping sweep initiative.”
MuckRock News submitted requests to the SEC for specific exhibits from 2011 to 2020 for a number of companies, mostly pharmaceutical and biologics firms.
Alexander Osipovich of The Wall Street Journal submitted five FOIA requests to the SEC on May 16 for annual FOCUS reports for Jump Trading LLC from 2019 to 2023. The SEC uses a FOCUS report (“Financial and Operational Combined Uniform Single report”) to assess the financial and operational health of a registered broker-dealer. Osipovich has been on the trail of high-speed trading giant Jump Trading for at least a year.
Several requests were submitted during May that referenced organizations involving former president Donald Trump. Corky Siemaszko of NBC News Digital submitted a request “seeking all complaints to the SEC from US residents pertaining to TRB, TRB Agency, Trump Rebate Banking System, Copecart, Copecart Systems, Patriots Dynasty, Patriots Future and USA Patriots from January 2020 to present.” Jonathon Meskauskas requested “the prospectus filed by Trump Media and Technology Group.” Meskauskas, who filed 10 other recent requests with the SEC, wasn’t further identified. A person with the same name currently is in prison in Illinois, serving a 60-year prison sentence for murder and scheduled for release on Christmas Day, 2065.
Also, an unidentified requester on May 15 requested “all e-mail referencing Trump Media and Technology Group TMTG tick symbol DJT from Jan 01, 2024, to Current,” and a separate request for a search of “Gary Gensler, Hester Pierce, Caroline Crenshaw, Mark Uyeda, and Jaime Lizaraga e-mail(s) referencing Trump Media and Technology Group TMTG ticker symbol DJT.”
No FDA or SEC requests were submitted mentioning President Joe Biden.
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
To see all the requests mentioned in this story, log in or sign up to become a FOIAengine trial user.
Next from FOIAengine: The SEC-mandated Consolidated Audit Trail attracts litigation – and FOIA requests.
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 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].
