New Questions about FDA and Pharma

by | Apr 9, 2025 | FDA, FOIA, Medical Devices, Pharmaceuticals

FOIAengine: Revolving Door Hits Pfizer on the Way Out

The revolving door between the Food and Drug Administration and the pharmaceutical industry took another fast spin when Pfizer announced that Patrizia Cavazzoni would be returning to the company as its chief medical officer – weeks after her Inauguration-eve departure as the Biden Administration’s top regulator of prescription and over-the-counter medicines.  

Although the shuffling of former federal employees into jobs as lobbyists, consultants, and strategists is not unusual, the reaction to Cavazzoni’s return to Pfizer marked a rare consensus among MAGA voices and left-leaning public interest organizations.  Both sides issued condemnations – resulting in new Freedom of Information Act requests, more questions about the FDA’s credibility, and adding yet another controversy for Pfizer amid reports of a federal investigation into whether the drug maker purposely delayed announcing the success of its Covid vaccine until after the 2020 election.   We’ll break all this down below, starting with the Cavazzoni announcement and the fallout, then moving to the resultant FOIA requests and the recent report of the federal investigation.  

Public Citizen’s Health Research Group Director Dr. Robert Steinbrook immediately issued a terse statement about Cavazzoni’s job switch titled, “The Revolving Door Must End.”  It said, in full:  “Patrizia Cavazzoni left Pfizer in 2018 to work at the FDA, so her return to Pfizer after leaving the FDA is totally unsurprising.  Cavazzoni’s move demonstrates that the revolving door between the FDA and the industries it regulates is alive and well and continues to undermine the FDA’s credibility as a public health agency.  The FDA should prioritize the recruitment of high-ranking officials who have no industry ties and who make a commitment not to leave the agency for industry.”

Vinay Prasad, a hematologist-oncologist known for his vocal opposition to elements of the Covid response, also jumped on Cavazzoni’s move back to Pfizer in a same-day blog post titled “FDA approves Pfizer drugs with inadequate safety and efficacy data, and then regulators work for Pfizer.”  

Prasad, who aligns himself closely with Health and Human Services Secretary Robert F. Kennedy, Jr. – and who was said by Politico to be under consideration for a senior HHS job – has 310,000 followers on X, and thousands of paid subscribers to his blog.  He posted that Cavazzoni’s return to Pfizer represented “the core rot in American regulation.  The revolving door politics.  I find this behavior abhorrent, and it should be criminal.  Mr. Kennedy has vowed to stop this, and I welcome that.  Until it happens, American medicine labors under a curse:  We cannot trust our drug regulators to act in the public’s interest.  Instead, they too often are acting in their own.”  

Kennedy remained silent.  

Cavazzoni earned $400,000 per year during the Biden Administration as director of FDA’s Center for Drug Evaluation and Research, which has about 5,600 full-time employees responsible for evaluating new drug applications, monitoring approved drugs, and regulating drug manufacturing.  Cavazzoni’s 2023 financial disclosure listed a net worth of between $6.5 million and $17.2 million, plus pension interests from Pfizer and Eli Lilly and a Manhattan condominium.  In an email to FDA staff, Cavazzoni said “the time has come for me to be more present for my family, who have taken the backseat over the past few years due to the demands of my role and our critically important public health work.”  

Under FDA’s conflict-of-interest rules, Cavazzoni was required to notify the FDA of any job discussions with Pfizer that occurred while she was employed.  The ethics rules also typically impose, for at least a year, certain restrictions on contacts with her former agency.  The FDA didn’t respond to questions about what restrictions Cavazzoni would be subject to, and whether she notified the FDA about pre-employment discussions with Pfizer.  

Even before Pfizer’s announcement, a FOIA request seeking the calendars of Cavazzoni and other departing FDA officials was logged by the agency.  After Cavazzoni’s return to Pfizer was announced, there were more FOIA requests from vaccine activists, all focused squarely on Cavazzoni and the potential revolving-door conflicts of interest.  Although Pfizer is a frequent target of FOIA requests – PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, contains 780 requests naming Pfizer since 2020 – the recent FOIA requests about Cavazzoni signaled harshly negative publicity for Pfizer, and the likelihood of litigation and more bad publicity to come.   Cavazzoni’s rehiring, just weeks after her FDA exit, also indicated a disconnect with Pfizer CEO Albert Bourla’s efforts to curry favor with the Trump Administration, whose point man on drugs and vaccines, Kennedy, has been highly critical of the drug industry’s influence at the FDA.  

Functional Government Initiative’s FOIA request, logged several weeks after Trump’s inauguration (and before Cavazzoni’s rehiring at Pfizer was announced), sought the calendars “from September 27, 2023, until the date the search begins” for the FDA’s 12 top officials, including Cavazzoni.  The calendars could show contacts between soon-to-depart FDA executives and the pharma companies they oversee.  FGI is a right-leaning non-profit and a frequent FOIA litigant, with six lawsuits filed since mid-2023 against the FDA, among 61 FOIA lawsuits in all.  

Following Cavazzoni’s rehiring by Pfizer, more FOIA requests came in.  Plaintiff’s law firm Siri & Glimstad, which specializes in vaccine litigation, used FOIA to serve a records-retention notice on the FDA.  On March 26, the law firm requested “all emails, including attachments, sent and/or received by Patrizia Cavazzoni from January 1, 2020 through the date of the search that include @pfizer.com in any portion of an email address in the to, from, cc, and/or bcc fields.  Please note: The Federal Records Act ( FRA ) requires FDA to preserve Dr. Cavazzoni’s email communications despite her departure from the agency.”   For more about Siri & Glimstad’s vaccine litigation, see our 2024 story, “A Gambit to Allow Covid Vaccine Lawsuits.”  

On the day after Siri & Glimstad’s request, the FDA logged two more Cavazzoni-related FOIA requests from a group calling itself the Public Health Reform Alliance.  One request from PHRA sought  “communications to or from Dr. Patrizia Cavazzoni, former director, Center for Drug  Evaluation and Research, and employees, lobbyists, and/or representatives from Pfizer (Pfizer.com).”  The other FOIA request filed by PHRA sought documents that Cavazzoni presumably would have filed, as required by FDA ethics regulations, once she began negotiating with Pfizer: “records of STOCK Act notifications regarding future employment, and recusal forms filed for or by Patrizia Cavazzoni.”  PHRA, which isn’t found in the Internal Revenue Service’s listing of non-profit entities, is the plaintiff in 14 FOIA lawsuits, all filed within the past five months.   

U.S. Prosecutors Investigating Tip About Timing of Pfizer Vaccine:  The Wall Street Journal late last month reported that the U.S. attorney’s office in Manhattan is investigating a tip that Pfizer delayed announcing the success of its Covid vaccine in 2020 until after that year’s election.  According to the Journal, “Trump has long been fixated on the timing of the Pfizer vaccine.  He was livid when the company announced the results of its [Covid vaccine] trial” on November 8, the day after Joe Biden was declared the winner of the 2020 presidential election.  Two days later, Trump called out Pfizer for what he implied was a last-minute effort to rig the election for Biden, saying “they didn’t have the courage to [announce] it before.”  An earlier announcement, according to the Journal, “could have reflected well on his management of the pandemic and reassured voters as they headed to the polls.”  

The tip to the U.S. attorney’s office for the Southern District of New York reportedly came from Philip Dormitzer, who led Pfizer’s vaccine R&D before moving to rival GSK in 2021.  He recently left GSK and now runs his own consultancy.  Dormitzer issued a statement denying there was a delay by Pfizer.  Pfizer also has denied any delay.  Nevertheless, the U.S. attorney’s office has been interviewing people in connection with the allegation.

The Journal’s March 26 scoop didn’t immediately trigger any FOIA requests to the FDA, and Dormitzer so far hasn’t shown up in the FOIAengine database.  The FDA didn’t respond to questions about whether the Manhattan prosecutor’s office had sought to interview anyone from the agency.  We will be keeping an eye out for further developments.    

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 article, log in or sign up to become a FOIAengine user.  

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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.  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 [email protected]

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