Investigation raises concerns about  ‘cozy relationship’ between the FDA and Moderna during Covid pandemic – after two officials got six-figure jobs weeks after approving firm’s shot

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) found two top FDA officials responsible for approving Covid vaccines who had joined the pharmaceutical giant and received six-figure salaries just months after the shots were given the green light.

The BMJ study by Dr. Peter Doshi, professor of pharmacy at the University of Maryland, warned of the lack of safeguards to prevent the “revolving door culture” that can 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 any official or employee of their former agency on behalf of anyone seeking official action.”

But 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. Goswami left the FDA and joined Moderna within the same month

Drs. Fink and Goswami worked for years at the FDA as medical supervisors for vaccines.

Dr. Fink worked his way up to the position of chief medical officer in the FDA’s Office of Vaccines Research and Review, where he remained until his appointment as acting deputy director of the Office of Vaccines 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 part of the decision to approve the mRNA shots from Pfizer-BioNTech and Moderna.

He left that position in December 2022. Just two months later, he took the six-figure job of chief of Translational Medicine and Early Clinical Development within Moderna’s infectious diseases division.

Meanwhile, Dr. Goswami will serve as Medical Officer for the agency’s Center for Biologics Evaluation and Research from March 2020 to June 2022.

In that role, she had, in her words, “broad oversight of the clinical development of vaccines and biologics.”

She was responsible for evaluating whether clinical data produced by Moderna related to the two-dose Covid shot 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 director of clinical development in infectious disease treatments and vaccines.

While specific salary data for these positions at Moderna is not available, salaries for similar positions at the company in managerial and executive positions often vary from $195,000 to as high as $330,000 per year.

Meanwhile, the average salary of an FDA employee is… hovers around $133,000.

When agency staffers go to work for the companies whose products they reviewed and approved, they raise concerns about conflicts of interest and impartiality that undermine the FDA’s objectivity when it comes to determining the fate of their products.

The questionable speed at which regulators are moving from lower-paying government jobs to lucrative private-sector posts is not unique to Covid-19-era developments or even to the FDA.

A 2016 report concluded that over a quarter of FDA officials who reviewed cancer and hematology drugs for approval left their federal oversight posts to work for the industry they previously regulated.

The revolving door culture can be difficult to grasp because the government has a lax enforcement protocol, said Dr Doshi, who is campaigning for greater transparency of clinical trial data.

For its part, the FDA said the agency “has more stringent ethical restrictions than most other federal agencies.”

“The FDA takes seriously its obligation to ensure that the decisions and actions taken by the agency and its employees are not, nor appear to be, tainted by any conflict of interest.”

The revolving door problem was especially damning in former FDA official Curtis Wright’s transition from regulator to director of medical research at Purdue Pharma.

Three years before taking the lucrative job at the manufacturer of OxyContin, the opioid that has caused the overdose crisis, Dr. Wright led the agency’s effort to approve it in 1995.

The FDA is far from the only agency whose employees have moved to higher-paying private-sector jobs for questionable reasons.

A recent study conducted 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 for another job went to the private sector. healthcare sector, where employees could rightly receive higher salaries.

Craig Holman, government affairs lobbyist for consumer watchdog group Public Citizen, said: “The revolving door is especially offensive at agencies where there is a huge flow of money coming in.”

“And so we need safeguards to ensure that they serve the public interest… You need a period where the close relationships and the networks more or less break down.”