An investigation has raised concerns about the “cozy relationship” between the Food and Drug Association (FDA) and Moderna during the Covid pandemic.
The report, published in the British Medical Journal (BMJ), reveals that two senior FDA officials responsible for approving Covid vaccines joined the pharmaceutical giant and were paid six-figure salaries just months after the jabs were given the green light was given.
The BMJ study by Dr. Peter Doshi, a professor of pharmacy at the University of Maryland, warned of the lack of safeguards to prevent the “revolving door culture” that could create “at least the appearance of a conflict of interest.”
Technically, FDA employees must wait a year before lobbying or “having any communication with or appearing before an official or employee of their former agency on behalf of a person requesting official action.”
However, the BMJ investigation found that Dr. Doran Fink and Dr. Jaya Goswami slipped through the cracks because the FDA doesn’t track where workers go.
Dr. Doran Fink left his leadership position at the FDA, where he was instrumental in the approval of the Moderna Covid vaccines, before joining the company just two months later.
Dr. Goswami left the FDA and joined Moderna in the same month
Dr. Fink and Goswami worked for years at the FDA as medical vaccine regulators.
Dr. Fink worked his way up to Chief Medical Officer in the FDA’s Office of Vaccine Research and Review, where he remained until his appointment as Acting Deputy Director of the Office of Vaccine Research and Review.
At the FDA, the physician scientist was responsible for working with vaccine manufacturers to advise them on vaccine development during the pandemic.
He was ultimately involved in the decision to approve the mRNA shots from Pfizer-BioNTech and Moderna.
He left this post in December 2022. Just two months later, he held the six-figure position of head of translational medicine and early clinical development in Moderna’s infectious diseases division.
Meanwhile, Dr. Goswami will serve as Medical Officer for the agency’s Center for Biological Evaluation and Research from March 2020 to June 2022.
In that role, she had, as she put it, “extensive oversight of the clinical development of vaccines and biologics.”
She was responsible for determining whether the clinical data Moderna produced related to the two-dose Covid vaccination met the agency’s regulatory standards for approval. The vaccine was finally approved in January 2022.
In June 2022, the same month she left the FDA, she joined Moderna as head of clinical development for infectious disease treatments and vaccines.
Although specific salary data is not available for these positions at Moderna, salaries for comparable senior and executive positions at the company typically range from $195,000 to up to $330,000 per year.
The average salary of an FDA employee is now about $133,000.
When agency employees work for the companies whose products they have reviewed and approved, they raise concerns about conflicts of interest and impartiality that undermine FDA’s objectivity in determining the fate of their products.
The questionable speed at which regulators are moving from low-paying government jobs to lucrative private-sector jobs is not limited to Covid-19-era developments or even the FDA.
A 2016 report concluded that more than a quarter of FDA officials who reviewed cancer and hematology drugs for approval left their federal regulatory jobs to work for the industry they previously regulated.
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“The revolving door culture can be difficult to understand because the government has a lax enforcement protocol,” said Dr. Doshi, who advocates for greater transparency in clinical trial data.
The FDA, for its part, said the agency has “stricter ethical constraints than most other federal agencies.”
“The FDA takes seriously its obligation to ensure that the decisions and actions of the agency and its employees are not affected or appear to be affected by a conflict of interest.”
The revolving door problem was particularly devastating during the transition of former FDA official Curtis Wright from regulator to director of medical research at Purdue Pharma.
Three years before he took the lucrative job at the maker of OxyContin, the opioid that caused the overdose crisis, Dr. Wright in 1995, the agency’s efforts to gain approval.
The FDA is far from the only agency whose employees have moved to higher-paying jobs in the private sector for dubious reasons.
A recent study by researchers at the University of Southern California and Harvard University found that between 2004 and 2020, 54 percent of Centers for Disease Control and Prevention employees who left the agency to take jobs elsewhere went to the private sector. health sector, changed where employees were employed. could rightfully receive higher salaries.
Craig Holman, government affairs lobbyist at the consumer advocacy group Public Citizen, said, “The revolving door is particularly offensive at agencies that receive a large influx of money.”
“And that’s why we need safeguards to ensure that it serves the public interest… There has to be a time when the close relationships and networks more or less break down.”
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
