FOIA Documents Reveal How 2 FDA Vaccine Oversight Staffers Sought Employment With Moderna

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Two former U.S. Food and Drug Administration (FDA) staffers who oversaw the mRNA COVID-19 vaccines now work at Moderna.

Documents obtained under the Freedom of Information Act (FOIA) reveal how two federal employees involved in the mRNA COVID-19 vaccine approval sought employment with Moderna.

Drs. Doran Fink and Jaya Goswami: Two former U.S. Food and Drug Administration (FDA) staffers who oversaw the mRNA COVID-19 vaccines now work at Moderna.

According to their LinkedIn pages, Dr. Fink, former acting deputy director at the Office of Vaccine Research and Review, now heads clinical development in infectious diseases at Moderna. Dr. Goswami, a former medical officer at the FDA’s Center for Biologics Evaluation and Research, is currently a director of clinical development in the infectious diseases department at Moderna.

Their change in employment came to light in a 2023 British Medical Journal (BMJ) investigation by professor Peter Doshi from the University of Maryland.

In the investigation, Mr. Doshi voiced concerns about a “cosy relationship” between the FDA and Moderna.

The FDA Recusal Process

A FOIA document illustrates the process involved when FDA employees decide to transfer to pharmaceutical companies.

FDA employees seeking or being offered non-federal employment “must recuse/disqualify from participating in any and all particular matters that would have a direct and predictable effect on the prospective employer’s financial interests,” Cherie Jones, the FDA’s ethics program specialist, wrote in an email released under the FOIA.

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This should be done “as soon as you reach out to a prospective employer by sending a resume or other forms of interest in employment,” she added.

This means that if FDA staff intend to seek jobs at Moderna, they should be recused from tasks related to any drugs or vaccines Moderna is or plans to work on or those associated with Moderna’s competitors.

Email exchanges show that Dr. Fink notified his supervisors of a possible recusal before he started applying for employment within the industry.

They also show that on the day Dr. Goswami accepted an offer from Moderna, her manager discussed with the FDA advice team which duties she should be recused from.

“[It] seems clear Goswami’s supervisor did not know Goswami was interviewing with Moderna … the morning Goswami told her supervisor that she had accepted a job at Moderna, the supervisor contacted ethics asking specific questions about what Goswami could work on,” Michael Chamberlain, the head of Protect the Public’s Trust, whose organization filed a FOIA request, told The Epoch Times.

In part, the FDA recusal process aims to avoid potential conflicts of interest. However, some experts point out that this process has limitations and may not be enough.

‘Cozy’ Relationships and Ethical Concerns

If FDA staff fail to submit timely recusals, their independence of judgment could be affected in the meantime. Even in cases where an FDA staffer properly adheres to recusal requirements, the public’s trust and regulation protocol may still be adversely affected. They “still had capacity to talk with and influence FDA staff who were working in the vaccine realm,” University of Maryland professor Linda Wastila, who has a doctorate in health policy and whose expertise lies in pharmacotherapy and drug policy, told The Epoch Times.

She pointed to a passage in the email exchanges that mentioned that former employees are restricted from making communications or appearances to influence any federal agency, court, or person regarding matters they participated in or were responsible for during their federal service.

However, the same passage also mentioned that the former employees “may still be permitted to work ‘behind‐the‐scenes’ advising others on the communication.”

Given this, Ms. Wastila feels that a simple recusal may be insufficient, suggesting that former federal staffers may need to be restricted from industry jobs for “a cooling-off period,” such as two years, after their federal service.

According to his LinkedIn profile, Dr. Fink was a senior FDA officer deeply involved with vaccine regulation for over 12 years. He left the FDA in December 2022 and started working with Moderna in February 2023.

The BMJ investigation reported that Dr. Goswami had, in her own words, “broad oversight over vaccines and biologics clinical development.” She worked at the FDA and was in the Vaccines Research and Review office before she left in June 2022 to start her job with Moderna that same month.

The problem with this revolving door is that public-serving agencies may gradually be co-opted from serving the public to serving the private industries, Ms. Wastila warned.

The FDA has proprietary information that is valuable to the industry, and hiring a specific former senior FDA staffer may allow pharmaceutical companies to learn all the regulatory pathways and shortcuts. “Knowing who in the agency is a tough shell or an easy touch, and simply understanding the fastest way to get a product to approval at the lowest cost” could be useful information for pharmaceutical companies, said Ms. Wastila.

“Having a former FDA advisor provide that information to pharmaceutical companies imparts unfair competitive advantage and begins to take the FDA’s purview ‘to serve the public interest’ to a private one,” she explained.

“In other words, the relationship becomes too cozy between the private sector and its regulator.”

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