By any economic measure, the Food and Drug Administration (FDA) is one of the most important regulatory bodies in the federal government. Its decisions influence hundreds of billions of dollars in private investment, determine the pace of medical innovation, and shape the cost structure of the entire U.S. healthcare system. Unfortunately, the agency is currently mired in dysfunction, internal conflict, and collapsing morale—problems the White House can no longer afford to overlook.
The turmoil began soon after FDA Commissioner Marty Makary took office this past spring. His tenure has been marked by aggressive shake-ups, a wave of firings, and controversial appointments that destabilized the agency’s two core scientific centers.
The FDA’s Center for Biologics Evaluation and Research (CBER) regulates complex biologics—such as vaccines, blood products, gene and cell therapies, and related devices. Its counterpart, the Center for Drug Evaluation and Research (CDER), oversees traditional drugs, from prescription medications to over-the-counter products. Together, they oversee nearly every medical therapy Americans rely on.
However, these objectives are at risk under current leadership. A recent feud inside CBER left staff “rife with mistrust and paranoia,” with scientists “terrified of pushing back” against CBER Director Vinay Prasad for fear of retaliation.
CDER, which is the FDA’s largest unit, experienced its own upheaval as veteran officials were forced out in rapid succession—earlier this week the newly installed head of the CDER, Richard Pazdur, announced his retirement from the agency just weeks after assuming the position. These exits have contributed to a leadership vacuum and deepened uncertainty across the agency.
Makary’s handpicked CDER chief, George Tidmarsh, resigned almost immediately after an ethics probe found he misused his position to pursue a personal vendetta. The episode pitted Tidmarsh against Prasad and left the drug center “riven by low morale” as more than 1,000 staffers resigned.
The chaos was compounded by Prasad’s hostility toward other FDA leaders: Prior to joining the agency, he earned a reputation as a strident critic of its drug-approval processes, often calling out top officials—especially Pazdur—for unusually personal criticism.
In 2022 Prasad wrote a piece on his substack declaring that “Rick Pazdur has . . . done a catastrophically bad job,” and accusing Pazdur of keeping the industry “rich” at the expense of patients. In another post, Prasad imagined Pazdur instructing researchers to “punish those people, kill them, if you have to” when designing oncology trials—a grotesque accusation that has alarmed many inside the agency.
Once inside the FDA, Prasad alienated veteran scientists, pushed out at least seven senior leaders, and prompted an exodus of talent. The agency also prohibited transfers to prevent employees from escaping an increasingly dysfunctional division. CBER lost hundreds of staff, leaving the biologics regulator understaffed and overwhelmed.
This breakdown in leadership is not just an internal management failure—it is an economic threat. The FDA’s FY 2025 budget of roughly $7.2 billion supports nearly 20,000 employees, including more than a thousand scientists and reviewers in CBER alone. These teams form the backbone of the U.S. innovation pipeline. Delays, vacancies, and management churn directly slow the review of new medicines and vaccines, creating bottlenecks that ripple across the industry as well as the U.S. economy.
The biologics sector—which is CBER’s jurisdiction—has an enormous impact on the broader pharmaceutical sector: global biologics revenue reached an estimated $440 billion in 2024, and economists anticipate the sector will expand rapidly in the next decade. Regulatory paralysis at CBER translates into billions of dollars in delayed investments across the biotechnology industry. The pharmaceutical sector also generates substantial multiplier effects in R&D, manufacturing, and healthcare employment. When the FDA cannot function, the resulting uncertainty dampens hiring, capital formation, and long-term research commitments.
Recognizing the crisis, Makary turned to Pazdur—the FDA’s long-time oncology chief and in many ways the antithesis of Prasad—to run CDER. In a message to CDER staff, Pazdur emphasized collaboration and morale—an implicit rebuke of the heavy-handed, punitive leadership style that had taken root under Makary’s other appointees. Pazdur’s appointment reportedly came with a promise from Makary that he would have “autonomy and independence” from Prasad.
Unfortunately, Pazdur lasted less than two weeks in the job before he submitted his retirement and left the agency, and morale plummeted even further.
The FDA regulates products representing nearly 20 percent of U.S. consumer spending and drives investment decisions across the entire life-sciences sector. Beyond the safety concerns, a leadership vacuum at an agency this consequential is also a national economic liability.
The markets and industry leaders are fed up with Makary and Prasad’s childish games. Hopefully, the White House recognizes this problem sooner rather than later, as the dysfunctional FDA is slowing down innovation and threatening lives.
