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Two U.S. Food and Drug Administration (FDA) medical officers involved with the agency’s decision in 2022 to license Moderna’s “Spikevax” COVID-19 vaccine immediately took jobs with Moderna after they left the FDA, a new investigation by The BMJ revealed.
The report comes just months after the U.K.’s former deputy chief medical officer, who made governmental contract decisions about the company’s COVID-19 vaccines, joined Moderna as a senior medical consultant.
According to The BMJ’s investigation, Doran Fink, M.D., Ph.D., worked his way up at the FDA “with a focus on the regulation of vaccines.”
After starting as a clinical reviewer in 2010, Fink was promoted to lead medical officer in the FDA’s Office of Vaccines Research and Review, according to his LinkedIn profile.
During the pandemic, Fink served on the agency’s senior leadership team for COVID-19 vaccine review and policy activities and “took part in the ultimate decision to license the Pfizer and Moderna vaccines.”
In April 2022, Fink became acting deputy director of the Office of Vaccines Research and Review. He left the FDA in December 2022, and two months later was heading up Moderna’s translational medicine and early clinical development program in infectious diseases.
Dr. Jaya Goswami, in March 2020, became a medical officer in the FDA’s Center for Biologics Evaluation and Research where she was responsible for evaluating whether the clinical data for Moderna’s COVID-19 vaccine met regulatory standards for approval, The BMJ said.
In June 2022, Goswami left the FDA and joined Moderna as its director of clinical development in infectious diseases, her LinkedIn profile (which is no longer visible) stated, according to The BMJ.
“To review Moderna’s approval and then work for the company a few months later, it just does not inspire confidence,” said Doshi, who also is an associate professor at the University of Maryland School of Pharmacy and a drug approval process researcher. “It risks undermining public trust in the regulatory process.”
FDA has a ‘real problem’
Craig Holman, a government affairs lobbyist for the consumer advocacy nonprofit Public Citizen, agreed with Doshi. He told The Defender, “The FDA clearly has a real problem when it comes to the revolving door.”
The revolving door “goes both ways,” Holman said, noting that the FDA routinely hires people from the pharmaceutical industry.
According to Holman, the revolving door is problematic in two ways. First, people working at the FDA know that, after getting regulatory experience at the agency, they will have more lucrative job prospects in the pharmaceutical industry.
“You wonder if they’re actually pursuing the public interest while in office,” Holman said. It would be easy to have a conflict of interest by making decisions at the FDA that benefit a pharmaceutical company where one wishes to one day be employed, he said.
Second, once individuals leave the FDA, they “are very expensive to hire” because they have connections at the FDA and regulatory know-how.
This means that only wealthier companies like Moderna can afford to hire them.
Jeremy Kahn, an FDA press officer, told The BMJ the FDA has “more enhanced ethics restrictions than most other federal agencies.” He said:
“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 agency provides robust information and resources to employees regarding the steps that must be taken to fulfil these ethics obligations.”
However, The BMJ pointed out that adherence to these obligations is “inevitably self-enforced.”
Khan did not respond to questions from The Defender regarding who, if anyone, checks to ensure that FDA employees are fulfilling their ethical obligations.
The BMJ filed a Freedom of Information Act request with the FDA to discover whether Fink or Goswami sought guidance from the FDA’s Office of Ethics and Integrity before shifting to Moderna.
Holman told The BMJ those in the public sector “are expected to serve the public interest … so, we need safeguards to make sure they are serving the public interest.”
There is no law forbidding employees who leave the FDA to immediately begin working for the industry they had been regulating, Holman said.
Holman advocates for a “cooling off” period of at least two years. “You need a period of time where the close relationships and the networks kind of break down,” he told The BMJ.
Doshi agreed. “Public service can’t be treated as ‘just another job,’” he said. “I think it’s imperative that HHS [the U.S. Department of Health and Human Services, which oversees the FDA] institute some kind of mandatory ‘cooling-off’ period for employees leaving public service.”
To that end, Holman helped draft legislation — introduced in last year’s congressional session by former Rep. Karen Lorraine Jacqueline “Jackie” Speier (D-Calif.) — that would have prohibited anyone in the FDA responsible for issuing a contract to a company from taking a job with that company for two years.
It also would have prohibited FDA workers who had previously worked for pharmaceutical companies to “influence” FDA decision-making in a way “that provides a direct and substantial pecuniary benefit for a former employer or former client.”
However, “the bill did not even get a hearing,” Holman said.
Speier has since left Congress, so it would be up to someone else to pick it up, he added.