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 in charge of approving Covid vaccines left to join the pharma giant and received six-figure salaries just months after the shots got the green light.
The BMJ investigation by Dr Peter Doshi, University of Maryland pharmacy professor, warned about the lack of safeguards to prevent the ‘revolving door culture’ that can create ‘at least the appearance of conflicts of interest’.
Technically FDA employees are supposed to wait one year before lobbying or having ‘any communication to or appearance before any officer or employee of their former agency on behalf of anyone seeking official action.’
But the BMJ probe found that because the FDA keeps no record of where employees go, Dr Doran Fink and Dr Jaya Goswami slipped through the cracks.
Dr Doran Fink left his position in leadership at the FDA where he was instrumental in approving the Moderna covid shots before moving on to work for the company just two months later
Dr Goswami left the FDA and took at job at Moderna within the same month
Drs Fink and Goswami worked at the FDA for years as medical regulators for vaccines.
Dr Fink worked his way up to the post of lead medical officer in the FDA’s Office of Vaccines Research and Review, where he stayed 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 the development of vaccines during the pandemic.
He was ultimately part of the decision to authorize the Pfizer-BioNTech and Moderna mRNA shots.
He left that role in December 2022. Just two months later, he took the six-figure job of Head of the Translational Medicine and Early Clinical Development within the department of infectious diseases at Moderna.
Meanwhile, Dr Goswami held her position as Medical Officer for the agency’s Center for Biologics Evaluation and Research from March 2020 until June 2022.
In that post she had, in her words, ‘broad oversight over vaccines and biologics clinical development’.
She was responsible for evaluating whether clinical data produced by Moderna regarding its two-dose Covid shot met the agency’s regulatory standards for approval. Ultimately, the vaccine was licensed in January 2022.
In June 2022, the same month that she left the FDA, she moved on to take a position at Moderna as Director of Clinical Development in treatments and vaccines for infectious diseases.
While specific salary data for those positions at Moderna are not available, salaries for similar positions at the company in executive and leadership roles tend to range from $195,000 to as high as $330,000 annually.
The average salary of an FDA worker, meanwhile, hovers around $133,000.
When agency staffers go to work for the companies whose products they reviewed and voted to approve, 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 transition from lower-paying government jobs to lucrative posts in the private sector is not unique to Covid-19-era developments or even 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 hard to grasp because the government has maintained a lax enforcement protocol, according to Dr Doshi, who campaigns for greater transparency of clinical trial data.
The FDA, for its part, said the agency ‘more enhanced ethics restrictions than most other federal agencies.
‘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.’
The revolving door problem was especially damning with former FDA official Curtis Wright’s transition from agency regulator to director of medical research at Purdue Pharma.
Three years before taking the lucrative job at the manufacturer of OxyContin, the opioid that helped drive the overdose crisis, Dr Wright led the agency’s charge in 1995 to approve it.
The FDA is far from the only agency whose employees have moved on to higher-paying private-sector jobs for dubious reasons.
A recent study conducted by researchers at the University of Southern California and Harvard University reported that between 2004 and 2020, 54 percent of workers at the Centers for Disease Control and Prevention who left the agency for another job moved into the private health sector where workers can get higher salaries.
Craig Holman, government affairs lobbyist for the consumer watchdog group Public Citizen, said: ‘The revolving door is particularly abusive in agencies that have a huge flood of money going in.’
‘And so, we need safeguards to make sure they are serving the public interest… You need a period of time where the close relationships and the networks kind of break down.’