Several former officials with the U.S. Food and Drugs Administration (FDA) took high-paying jobs with pharmaceutical companies after playing key roles in pushing those Big Pharma firms’ Covid shots through the regulation process.
The “revolving door” was exposed during an investigation by the renowned peer-reviewed British Medical Journal (BMJ).
The discovery is reminiscent of former FDA official Curtis Wright IV.
Wright played a central role in the FDA’s approval of the dangerously addictive opioid OxyContin for Purdue Pharma in 1995.
Shortly after, he left the FDA for a job at Purdue and a massive salary with the company.
The actions of Wright, who is portrayed in TV shows, films, and reports in nonfiction books, magazines, and news media outlets, directly contributed to America’s opioid crisis, the effects of which are still felt today.
Now, the BMJ has just uncovered evidence to suggest a similar scenario may have played out with the approval of Covid shots, specifically Moderna’s mRNA injection.
Two high-level regulatory officials with the FDA involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine.
According to the BMJ investigation, these FDA officials were central to the shots being approved for public use.
After their vaccines were approved for public use, Big Pharma companies earned billions of dollars in profits from sales of the injections.
The report on the investigation was authored by Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ.
The investigation has exposed a long-standing revolving door between the FDA and pharmaceutical companies whose products it regulates and raises questions about the impartiality and independence of top FDA regulators.
Dr. Doran Fink is a “physician/scientist experienced in regulation and clinical development/licensure of vaccines and related biological products.”
Fink was deeply involved with vaccine regulation at the FDA for more than 12 years, according to his LinkedIn profile.
According to the BMJ report, Dr. Fink started his FDA career as a clinical reviewer in 2010.
He eventually “worked his way up” to Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review.
There, he led a team of medical officers focused on infectious diseases and related biological projects.
During the COVID-19 pandemic, Dr. Fink was a prominent voice on COVID-19 vaccines and which population groups should receive them.
He spoke on behalf of the FDA at numerous meetings held by the agency’s vaccine advisors who met to discuss whether to approve COVID-19 vaccines, change their composition, or authorize boosters.
Dr. Fink also presented at meetings held by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices as the FDA’s “principal FDA ex officio representative.”
The CDC committee is a group of health experts that develop recommendations on how to use vaccines.
According to the BMJ report and Dr. Fink’s LinkedIn profile, Fink also served on the senior leadership team for COVID-19 vaccine review and policy activities in response to the COVID-19 public health emergency.
As part of his role, he advised vaccine manufacturers on vaccine development throughout the pandemic.
He also coordinated “expedited review of regulatory submissions,” advised U.S. government stakeholders outside the FDA on COVID-19 vaccine science and development, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines.
Most notably, Dr. Fink engaged in a “senior level review” of the FDA’s decision memoranda for emergency use authorization and licensure of COVID-19 vaccines, including Moderna’s.
According to Fink’s LinkedIn profile, he left the FDA in December 2022.
He left the federal agency to start a job at Moderna as the head of “Translational Medicine and Early Clinical Development, Infectious Diseases” in February 2023.
Fink wasn’t the only federal health official to shift into the high-paying corporate pharmaceutical industry, however.
Dr. Jaya Goswami has a similar history.
Goswami began working as a medical officer at the FDA’s Center for Biologics Evaluation and Research in March 2020.
According to the BMJ report, Goswami had “broad oversight over vaccines and biologics clinical development.”
Goswami was responsible for determining whether Moderna’s COVID-19 vaccine clinical data met regulatory standards for approval to use the shots on the public.
In January 2022, Moderna’s SPIKEVAX received FDA approval.
Shortly after, in June 2022, Goswami’s LinkedIn profile said she left the FDA and began working for Moderna that same month.
In her new high-salary position at Moderna, Goswami lists herself as the director of clinical development in infectious diseases.
At Moderna, Goswami has been involved with the company’s investigational mRNA vaccine against respiratory syncytial virus (mRNA-1345).
On July 5, the company announced in a press release that it had submitted marketing authorization applications with the European Union, Switzerland, and Australia.
Moderna also revealed that it has submitted a “rolling submission of a Biologics License Application” to the FDA.
That submission will be reviewed by the department within the FDA that employed Drs. Fink and Goswami.
According to Moderna, the company made $18.5 billion in 2021 from sales of its COVID-19 vaccine.
The pharmaceutical giant went on to make more than $19 billion in 2022.
For 2023, Moderna projects sales of its COVID-19 vaccine will reach at least $6 billion in 2023.
Writing for The BMJ, Dr. Doshi warns that this is another sign of the “revolving door” between Big Pharma companies and the regulators entrusted with regulating their products.
Both FDA employees worked in vaccine regulation during the COVID-19 pandemic and joined Moderna.
At the time, Moderna’s only product was its COVID-19 vaccine.
“The revolving door is particularly abusive in agencies that have a huge flood of money going in,” Craig Holman, a government affairs lobbyist for Public Citizen, told The BMJ.
“That’s a big problem with the FDA.”
Holman was referring to the federal funding Moderna received that helped expedite the authorization of COVID-19 vaccines.
Holman suggests a “cooling-off period” of at least two years to break down close relationships and networks that could present an ethical problem for employees who leave regulatory agencies for the companies whose products they regulate.
FDA press office Jeremy Kahn told the BMJ the agency has “more enhanced ethics restrictions than most other federal agencies.”
Kahn insists that the FDA “takes seriously its obligation to help ensure that decisions made and actions taken, by the agency and its employees, are not, nor appear to be, tainted by any question of conflict of interest.”
Kahn also said the FDA provides “robust information and resources to employees regarding the steps that must be taken to fulfill these ethics obligations.”
However, the BMJ found the FDA doesn’t keep records of where employees go when they leave the agency.
Nor does the agency require employees to obtain approval or clearance before taking an industry job.
The BMJ asked the FDA whether the health regulators sought direction from the FDA’s Office of Ethics and Integrity before accepting positions with Moderna.
The journal also asked whether those officials recused themselves from any FDA matters related to their employment search.
The FDA told the BMJ to file a Freedom of Information Act (FOIA) request.
Chris Ridley, Moderna’s vice president of communications and media, said the company had “no comment” when asked the same questions by Doshi.
This is not the first time issues have been raised with the FDA’s “revolving door.”
The concept was defined in an October 2005 paper by the Revolving Door Working Group (RDWG) as the “movement of individuals back and forth between the private sector and the public sector.”
The government-to-industry revolving door is where “public officials move to lucrative private-sector positions in which they may use their government experience to unfairly benefit their new employer in matters of federal procurement and regulatory policy,” according to RDWG.
This may allow public servants to use their office for personal or private gain at the expense of taxpayers, cast doubts on the integrity of official actions, could influence a government employee’s official actions through promises of a future high-paying job with the company benefits from the official’s actions, could provide an unfair advantage or give the appearance of undue influence and impropriety.
In a 2016 study published in The BMJ, researchers followed 55 medical reviewers involved in drug approvals in the FDA’s hematology-oncology division over several years.
Of 26 medical reviewers who left the agency, 15 went to work for the biopharmaceutical industry, were consultants to it, or did both.
In 2018, a search conducted by the journal Science found that 11 of 16 FDA medical examiners involved with 28 drug approvals left the agency for new jobs in the private sector.
They all took jobs or became consultants with companies whose products they recently regulated.
Another prominent example of a top regulatory official who left the FDA to work for the drug industry is former FDA commissioner Dr. Scott Gottlieb.
Gottlieb unexpectedly resigned in March 2019 after less than two years of serving in the position.
In June 2019, Pfizer announced that Dr. Gottlieb had been appointed to its board of directors “effective immediately.”
He joined the company’s Regulatory and Compliance Committee and the Science and Technology Committee.
Dr. Gottlieb, who is also a CNBC contributor, was frequently consulted by news media outlets on COVID-19 vaccines.
He helped the company rake in more than $100 billion in sales of its vaccine and anti-viral drugs.
He also flagged tweets that questioned COVID-19 vaccines for Twitter/X, as revealed by the Twitter Files.