When President Trump returned to the White House, many expected his Food and Drug Administration (FDA) to once again reflect the bold vision of his first term that encouraged faster access to drugs and a stable, pro-innovation culture built around biology and unmet need. In reality, however, new leadership at the FDA has unfortunately produced the opposite, much to the detriment of American patients.
The issues started in April, when the FDA workforce was reduced by 3,500. Concerns were raised that the loss of key scientific personnel could affect functions such as timely drug approvals, regulatory guidance, and innovation. Staffing shortages certainly have not helped the situation, but frequent infighting and scandals among top FDA leaders may be the cause for greatest concern. A fear where personality and politics seem to triumph over rules and results have settled over the agency. This is a source of delay and doubt that must be resolved.
At the center of this chaos is FDA Commissioner Dr. Marty Makary and a top expert he recruited: Dr. Vinay Prasad. On paper, Prasad is a highly qualified physician and researcher with stellar credentials to serve at the FDA. But he also holds strong political and personal viewpoints that have been cause for concern.
Dr. Prasad is a self-described Sanders/Warren progressive who openly loathes Trump. He currently serves as the head of Center for Biologics Evaluation and Research (CBER) and also as the Chief Medical Officer and Chief Scientific Officer at the FDA. From the outset, he used his power to purge senior gene therapy leadership that sent a chill through the sector.
A relentless leadership churn due in part to Prasad’s reported divisiveness and hostility to colleagues led to internal complaints and affected staff morale and FDA credibility. Dr. Prasad’s heavy-handed oversight of the gene therapy division, other aggressive internal moves and feuding led to calls for his removal and eventually his resignation in July. But less than two weeks after Prasad left the agency, he was rehired and has since been reinstated to all of his previous positions.
Things have once again come to a head in recent weeks when Dr. George Tidmarsh – a biotech veteran tapped to run the Center for Drug Evaluation and Research (CDER) and serve as a counterweight to Prasad – was accused of using his position of authority to publicly denigrate a treatment tied to a former business associate with whom he reportedly has a dispute. Although he denied these accusations, he was placed on leave and subsequently resigned, contending that senior officials, including Prasad, had contributed to a toxic work environment that undermined scientific judgment.
In what can be presumed as an attempt to signal a new order, Dr. Makary appointed Dr. Richard Pazdur, a 26-year veteran of the FDA, to replace Dr. Tidmarsh at CDER in early November. Even though he set a new tone focusing on staff support and morale, the effort failed. Pazdur announced his retirement, a mere three weeks into serving in the new role. This further underscores the ongoing chaos at the FDA. More drastic actions will now likely be necessary to bring about a true course correction at the agency.
Controversy is not new to the FDA. The industry that the agency regulates is valued at $1.6 trillion and consists of a workforce of scientific experts and high-powered entrepreneurs that would be difficult to manage under the best of circumstances. However, in its present state, one expert has described it as “stumbling through a bureaucratic fog in which innovation stalls and risks multiply.”
The FDA can and must do better by both preserving and modernizing the agency. As a group of biomedical innovators, investors and patient advocates have all suggested, that starts by identifying how FDA’s capabilities have been impacted in order to quickly preserve and restore necessary functions. From there, the agency must maintain timelines, faithfully apply the law and regulations, and ensure clarity and consistency by conducting ongoing dialogue. The FDA must also look to the future for better answers. Enhanced clinical trials, stronger post-market surveillance, faithful adherence to evidence-based results, and improved stakeholder engagement are critical especially to regain public trust. And a review of how new technology, such as AI and personalized medicine can streamline their effort could be an important step forward.
Ultimately though, the top issue at the agency is leadership. The FDA does not need what one commentator referred to as small men, “who are unable to cope with any kind of criticism or perceived threats to their authority.” It needs good leaders who can make the necessary judgement calls and decisions to move a project forward and who understand the importance of critical feedback and support their teams. Ultimately, they must place patient outcomes above professional rivalries. This isn’t always easy, but it is exactly what the doctor ordered.
Brenda Destro, Ph.D. served as the Acting Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services (HHS) from 2018-2021 and was previously a Senior Public Health Advisor to the Senate Committee on Health, Education, Labor, and Pensions (HELP).
