FDA and the Biden Administration on a new initiative.”
Tidmarsh’s ties to FDA leadership
While Tidmarsh doesn’t have the bureaucratic experience of his predecessors, his connections to the FDA’s new leadership team could be crucial. FDA Commissioner Makary is a fellow Stanford alum and has publicly supported Tidmarsh’s appointment. Tidmarsh’s relationships with Makary and Bhattacharya could help him navigate the agency’s new direction under the Biden Administration.
“Tidmarsh’s ties to Makary and Bhattacharya could give him an inside track on how to implement the FDA’s new policies and priorities,” said Khera. “His background in academia and biotech also give him a unique perspective on the drug evaluation process.”
Overall, Tidmarsh’s appointment as the director of CDER comes at a critical time for the FDA. With the agency facing challenges related to staffing, budget constraints, and the need to modernize its review process, Tidmarsh will have his work cut out for him. However, his experience in academia and biotech, as well as his connections to the FDA’s leadership, could position him well to lead the agency’s drug evaluation efforts in the years to come.
As a Stanford faculty member, it is important to acknowledge potential conflicts of interest that may arise when individuals transition into governmental agencies. One such example is Dr. George F. Tidmarsh, who recently joined the Center for Drug Evaluation and Research (CDER) at the FDA. Tidmarsh’s appointment to CDER came about through his connections with colleagues Makary and Bhattacharya, raising questions about potential conflicts of interest.
Critics have pointed out that Tidmarsh has been openly critical of public health policies, particularly the government’s response to the COVID-19 pandemic. In a podcast interview, he expressed frustration with the lack of academic freedom in public health decision-making during the pandemic, suggesting that the political polarization hindered the ability to arrive at the right solutions.
Furthermore, Tidmarsh has hinted at his support for the theory that the coronavirus originated from a lab in Wuhan, a viewpoint commonly held in right-leaning circles. This has raised concerns about his objectivity and impartiality in decision-making at CDER. Despite his criticisms of public health policies, Tidmarsh has also shown sympathy towards government leaders, acknowledging the challenges they face in making and enforcing decisions during a crisis.
In his new role at the FDA, Tidmarsh has expressed a desire to modernize the agency and improve efficiency in regulatory reviews. He aims to establish consistency in communication with sponsors and enhance the agency’s use of new technologies like AI and real-world data. However, concerns remain about the potential for inconsistent application of these technologies across different review divisions.
While Tidmarsh has praised the FDA and its staff, emphasizing the need for continuous improvement, questions linger about his ability to motivate people and lead effectively in a larger role. It is crucial for him to address these leadership challenges and ensure that decisions made at CDER are based on scientific evidence and public health priorities, free from political influence.
As Tidmarsh settles into his new position at the FDA, it will be important for him to navigate potential conflicts of interest and uphold the integrity of the agency’s regulatory processes. Transparency, accountability, and a commitment to public health will be essential in guiding his leadership at CDER and maintaining public trust in the FDA’s decision-making.
