Written by Following their oversight roles in COVID-19 vaccines, two regulators from the US Food and Drug Administration (FDA) transitioned to positions at Moderna, as reported by Peter Doshi on British Medical Journal.
Doran Fink, a physician-scientist, ascended through the ranks at the FDA, specializing in vaccine regulation. Commencing as a clinical reviewer in 2010, he earned a promotion to lead medical officer in the FDA’s Office of Vaccines Research and Review. In this capacity, he supervised a small team of medical officers with responsibilities for assessing infectious diseases and related biological products.
Throughout the COVID-19 pandemic, Fink assumed a public role, participating in numerous FDA and Centers for Disease Control and Prevention advisory committee meetings to deliberate on COVID vaccines. He also served on the senior leadership team overseeing COVID vaccine review and policy activities. His responsibilities included engaging with vaccine manufacturers to provide guidance on vaccine development during the pandemic. In mid-2020, Fink publicly communicated the FDA’s expectations for any COVID vaccine under consideration for authorization. Additionally, he played a role in the final decision to grant licenses to the Pfizer and Moderna vaccines.
Doran Fink concluded his tenure at the FDA in December 2022, according to information on his LinkedIn profile. Just two months later, he assumed a role at Moderna, leading the translational medicine and early clinical development program in infectious diseases. Fink is one of two regulators identified by The BMJ who recently transitioned from the FDA’s Office of Vaccines Research and Review to Moderna.
Concerns surrounding the “revolving door” phenomenon, where individuals move between government positions and the private sector, have persisted for decades. Public confidence in the integrity of government decision-making is at stake. Craig Holman, a government affairs lobbyist for the consumer advocacy organization Public Citizen, emphasizes the distinct nature of government service, asserting that public servants are expected to prioritize the public interest. Safeguards are deemed necessary to ensure alignment with these interests.
Jeremy Kahn, an FDA press officer, contends that the FDA maintains more robust ethics restrictions compared to other federal agencies. The agency is committed to preventing decisions and actions from being tainted by conflicts of interest, offering comprehensive information and resources to employees to fulfill ethical obligations.
However, The BMJ investigation reveals that the FDA lacks a system for tracking the post-government employment destinations of its former employees. There is no mandatory approval or clearance process before an employee can take up a position in the private sector. While post-government employment guidance exists, adherence is essentially self-enforced, relying on employees to follow the rules. The guidance includes a permanent ban on “switching sides” — communicating or appearing before the government on behalf of a new employer regarding specific matters in which the employee was substantially involved during government service. Those seeking or negotiating an industry job must immediately recuse themselves from relevant official matters.
Holman argues that the “revolving door” is especially problematic in agencies with significant financial influxes, citing concerns about the FDA, particularly in the context of the pandemic and Operation Warp Speed. He suggests that the FDA could legally prevent its employees from working for regulated companies and proposes measures such as an ethics pledge and a cooling-off period of at least two years. He points to precedents, such as the Obama administration’s prohibition on executive agency appointees lobbying the administration after leaving their positions. Many U.S. states have cooling-off laws, with Florida recently extending its period to six years.
The dangers associated with the revolving door between the FDA and the pharmaceutical industry are exemplified by the case of Curtis Wright and Purdue Pharma, extensively documented in literature and on television. Wright, during his time at the FDA, led the agency’s approval of OxyContin in 1995. The approval included labeling language that portrayed the opioid as having less misuse potential, a crucial element in Purdue’s strategy to market the drug to a broader audience. After leaving the FDA, approximately a year later, Wright accepted a position with Purdue, earning $379,000 per year.
While the Purdue Pharma case stands out for its severity, research suggests that the trend of individuals transitioning from the FDA to the pharmaceutical industry is not uncommon. A 2016 study in The BMJ tracked 55 medical reviewers from the FDA’s haematology-oncology division, revealing that of the 26 officers who departed the FDA, 15 subsequently worked or consulted for the industry. A separate investigation by Science magazine in 2018 reported that 11 out of 16 FDA medical examiners who worked on drug approvals and then left the agency were now employed by or consulted for the companies they had recently regulated, potentially raising concerns about conflicts of interest.
In a parallel situation to Doran Fink, Jaya Goswami joined the FDA’s Center for Biologics Evaluation and Research in March 2020. As a medical officer, she held oversight responsibilities for vaccines and biologics clinical development, evaluating clinical data for Moderna’s COVID vaccine. Licensure for the vaccine was granted in January 2022, and Goswami’s LinkedIn profile indicates that she left the FDA in June 2022, immediately taking on a new role as the director of clinical development in infectious diseases at Moderna.
Despite attempts to seek interviews with Fink and Goswami, both individuals did not respond. The BMJ sought information from them, Moderna, and the FDA regarding whether the former regulators sought guidance from the FDA’s Office of Ethics and Integrity before joining Moderna, and whether they recused themselves from FDA matters related to their employment search. The FDA directed The BMJ to file a Freedom of Information Act request for this information. Moderna’s response, conveyed by Chris Ridley, the vice president of communications and media, was, “We have no comment on your inquiry.”
Goswami’s role at Moderna involves contributing to the company’s efforts to bring an mRNA vaccine against respiratory syncytial virus (mRNA-1345) to market. In July of the same year, Moderna announced the submission of regulatory approval applications in the United States, the European Union, Australia, and Switzerland. Notably, the review in the U.S. is expected to be conducted by the FDA’s Office of Vaccines Research and Review, the very group that Fink and Goswami departed.
Prior to the COVID-19 pandemic, Moderna had limited regulatory experience. Established in 2010, the company had been working on various mRNA platform products, yet it had not successfully brought any product to market in its first decade of operation.
The turning point for Moderna came with the onset of the COVID-19 crisis. Moncef Slaoui, a seasoned pharmaceutical executive and a prominent member of Moderna’s board of directors, was appointed by President Trump to co-lead Operation Warp Speed. Upon his appointment, Slaoui sold his entire shareholding of approximately $12 million in Moderna stock and resigned from the Moderna board. However, he retained an estimated $10 million stake in GlaxoSmithKline, another beneficiary of Operation Warp Speed funds. Slaoui opted for a contractor position, exempting him from the disclosure and divestiture ethical requirements applicable to federal government employees.
Acting on behalf of Public Citizen, Craig Holman filed an ethics complaint against Slaoui, calling for his classification as a “special government employee” subject to federal conflict of interest codes and disclosure requirements. However, the complaint was not upheld.
Under Slaoui’s guidance, Moderna swiftly became a leading player in the race for a COVID-19 vaccine. A phase 1 clinical trial began just 66 days after the release of the viral sequence in March 2020. By midsummer, the U.S. had committed $955 million to support a phase 3 trial, with an additional $1.5 billion pledged through an advance purchase agreement for the delivery of 100 million doses. A congressional report in March 2021 estimated that Moderna had received $4.94 billion in federal funding for a total of 300 million doses.
On December 18, 2020, under the leadership of FDA Commissioner Stephen Hahn, the FDA granted the world’s first authorization to Moderna’s COVID vaccine, mRNA-1273. Six months later, after resigning from his post with the transition to the Biden administration, Hahn joined Flagship Pioneering, the venture fund that played a pivotal role in the founding of Moderna.