Former FDA Director Regulating Vaccines Joins Eli Lilly

• by Carolyn Hendler, JD

• Published November 12, 2025 
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  The former director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), Peter Marks, MD, PhD, who was responsible for the agency’s regulation of the safety and effectiveness of vaccines, joined drug giant Eli Lilly and Company after resigning from the agency on Mar. 28, 2025.¹ Dr. Marks alleged that his disagreement about the safety of vaccines with Secretary of Health and Human Services Robert F. Kennedy, Jr. forced his resignation. An anonymous FDA official stated that Marks was given the opportunity to resign or face being fired.²

  Marks stated that Kennedy is undermining public confidence in vaccines which was, “irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.”³

  At the time of his departure, a Department of Health and Human Services (DHHS) spokesperson said:

  If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.⁴

  Marks Was Instrumental in Operation Warp Speed

  As head of the CBER, Marks was in charge of assuring the safety and effectiveness of vaccines. During the COVID-19 pandemic, He was a key player in launching Operation Warp Speed (OWS) to hasten the development and mass distribution of the COVID shots.⁵

  Vinay Prasad, MD, MPH, who replaced Marks at the CBER is critical of FDA officials who head directly to jobs with Big Pharma after leaving their government positions. Posting on X, Dr. Prasad stated:

  The FDA is broken. Peter Marks is approving gene therapies that don’t work, and the revolving door to Pharma is spinning so fast it hits you in the ass.⁶

  Long History of Connection Between Government and Big Pharma

  The revolving door between government health positions and Big Pharma is not new. There is a long history of ex-FDA officials moving to work for the drug companies they used to regulate when in top positions at the FDA. Recently, these include Patrizia Cavazzoni, MD, former head of the FDA’s drug evaluation team, who joined Pfizer as its chief medical officer in February.⁷ Former FDA commissioner, Scott Gottlieb, MD became a member of Pfizer’s Board of Directors in 2019 just three months after leaving his top post at the regulatory agency.⁸

  A 2014 article published in the BMJ revealed that nine out of the last ten FDA commissioners left the agency to work for or serve on the board of a pharmaceutical corporation.⁹

  A 2016 BMJ study found that 15 out of 26 FDA staffers who conducted drug reviews in the hematology oncology field over a nine-year period left the government to work or consult for private biopharmaceutical companies. Another analysis by Science showed that 11 out of 16 FDA medical examiners, who played a role in approving 28 drugs, left the agency to work for or consult with pharmaceutical companies involved in the drugs they had regulated in their government agency position.¹⁰

  A 2018 Kaiser Health News (KHN) analysis of data provided by Legistorm, a website and research organization for government affairs professionals, raised concerns about the revolving door between government agencies and private pharmaceutical companies. The analysis showed that 340 former congressional workers made the jump to pharmaceutical companies, while more than a dozen ex-pharmaceutical employees moved over to a government job.¹¹

  Revolving Door Laws Do Not Go Far Enough

  A 2023 report on the revolving door that can also involve individuals working for government and, then, leaving government to work for Big Pharma, and then returning to government, found that more than half of the staff at the U.S. Centers for Disease Control and Prevention (CDC) go to work for pharmaceutical giants when they leave the government, including those employees who are directly involved in making national vaccine policy.¹² For example, Julie Gerberding, MD, MPH who was director of the CDC from 2006 to 2009 left that position and became President of the Vaccine Division for Merck & Co. in 2010.¹³ In 2022, she became CEO of the Foundation for the U.S. National Institutes of Health (NIH). ¹⁴

  The report concludes that current conflict of interest laws are not sufficient to prevent potential influence and corruption. The so-called “revolving door” laws prevent government employees from performing “representational” activities such as lobbying, communicating with or appearing before an officer or employee of their former agency for only 12 months after their government employment ends.¹⁵

  According to the founder and CEO of CareYaya and Counterforce Health, Neal K. Shah, MD:

  When FDA officials are employed in the industry, they are likely to make decisions that favor the pharmaceutical companies with which they have past associations and might have future ties. This poses particular dangers for a health care sector where safety is paramount. Former regulators might be too cozy with their former employers to enforce the kind of tough standards that are sometimes necessary.¹⁶

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