The investigation, conducted by Dr. Peter Doshi, a pharmacy professor at the University of Maryland, highlights the lack of safeguards in place to prevent conflicts of interest and the “revolving door culture” between regulatory agencies and pharmaceutical companies. According to the report, FDA employees are supposed to wait one year before lobbying or having any communication with their former agency on behalf of anyone seeking official action. However, due to the FDA's failure to keep records of where employees go, Dr. Doran Fink and Dr. Jaya Goswami were able to take lucrative positions at Moderna without any repercussions.
Both Dr. Fink and Dr. Goswami had worked at the FDA for years as medical regulators for vaccines. Dr. Fink was the lead medical officer in the FDA's Office of Vaccines Research and Review, where he played a key role in advising vaccine manufacturers during the pandemic, including the authorization of the Pfizer-BioNTech and Moderna mRNA shots. He left the FDA in December 2022 and joined Moderna just two months later as Head of Translational Medicine and Early Clinical Development within the department of infectious diseases.
On the other hand, Dr. Goswami served as a Medical Officer for the FDA's Center for Biologics Evaluation and Research, where she had oversight over vaccines and biologics clinical development. She evaluated the clinical data produced by Moderna for its two-dose Covid shot, which ultimately met the agency's regulatory standards for approval. In June 2022, she left the FDA and took a position at Moderna as Director of Clinical Development in treatments and vaccines for infectious diseases.
While specific salary data for these positions at Moderna is not available, similar roles in executive and leadership positions at the company typically range from $195,000 to as high as $330,000 annually. In comparison, the average salary of an FDA worker is around $133,000. The swift transition of FDA employees to high-paying private sector jobs raises concerns about conflicts of interest and impartiality, which can undermine the FDA's objectivity in evaluating and determining the fate of products.
This issue of the revolving door between regulatory agencies and the private sector is not unique to the FDA or the Covid-19 era. A 2016 report revealed 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 lax enforcement protocol and lack of stringent safeguards contribute to the revolving door culture, which compromises the public's trust in regulatory agencies' decision-making processes.
The FDA claims to have more enhanced ethics restrictions than most other federal agencies and takes the issue of conflicts of interest seriously. However, the case of former FDA official Curtis Wright transitioning from agency regulator to director of medical research at Purdue Pharma highlights the severity of the revolving door problem. Three years before taking the job at the manufacturer of OxyContin, Dr. Wright led the FDA's charge to approve the opioid that contributed to the overdose crisis.
The revolving door issue extends beyond the FDA, with a recent study reporting that 54 percent of workers at the Centers for Disease Control and Prevention (CDC) who left the agency for another job moved into the private health sector, where salaries tend to be higher. Safeguards are necessary to ensure that regulatory agencies serve the public interest and that close relationships and networks do not compromise impartiality. A period of time should be implemented to allow these relationships to break down and minimize conflicts of interest.
In conclusion, the investigation into the relationship between the FDA and Moderna raises concerns about conflicts of interest and the revolving door culture between regulatory agencies and pharmaceutical companies. The lack of safeguards and enforcement protocols contribute to the erosion of public trust and undermine the objectivity of regulatory agencies in evaluating and approving products. Efforts should be made to address this issue and ensure that the public's health and safety remain the top priority.
