As FDA funding debated, CDER chief makes a pitch for more scientists—not a reorganization

The head of FDA’s drug evaluation center says the agency needs “the right people and the right scientists and more of them” to bolster the review process for new drug applications, particularly those involving therapies for rare diseases. 

Patrizia Cavazzoni, M.D., head of the FDA’s Center for Drug Evaluation and Research (CDER), spoke during a presentation Monday to the lobbying group Alliance for a Stronger FDA about the upcoming budget for the FDA and CDER.

The deep dive into CDER’s future budget comes a week after the FDA released its funding requests for the upcoming fiscal year. The agency is asking for $8.39 billion, a 34% increase from the previous year, which would include nearly $2 billion for CDER. Cavazzoni says the center’s two funding proposals center around continuing its efforts to address the opioid epidemic and ramping up post-market drug surveillance.

Cavazzoni in her remarks highlighted priorities such as strengthening the center’s staffing, bolstering post-market surveillance and enhancing available supply chain data to better predict shortages of essential drugs. One of the areas that Cavazzoni said remained a top priority was advancing therapies for diseases with unmet medical needs, particularly rare diseases. She said an underfunded area within that domain is advancing the review program to hire more staff that are focused specifically on assessing new technology and innovation. 

“Where we don’t have the resources that I think we need is on the innovation front, particularly when it comes to drug development science,” she said. “But obviously if all our reviewers and our scientists are head down reviewing one application after the other ... we are really not going to be able to really leverage the tremendous innovation that is out there.”

Ideally, the agency could add scientists that would focus primarily on familiarizing themselves with advancements in rare disease and subsequently incorporating that info when assessing an application, according to Cavazzoni. Her comments also served as a rebuke to calls for the agency to merely reorganize itself to better handle this task. 

“What we do need are the right people and the right scientists and more of them in the boxes that we have now,” she said. 

Not unlike the labor market as a whole, FDA and CDER are hyperfocused on retaining and hiring new staff. The center is rebounding after historically low attrition levels at the start of the pandemic spiked over the summer of 2021, when a lot of staff retired. Cavazzoni said the 12-month attrition rate is now at 8%, which is around pre-pandemic levels. But one place with a net staffing gain is the office of new drugs, including the medical reviewer's discipline. 

Cavazzoni joined the FDA in 2018 as CDER's deputy director of operations after working in the pharmaceutical industry including stints at Pfizer, Eli Lilly and Sanofi. She was named the permanent head of the center last April and has had to navigate some tumultuous waters since, specifically the agency's decision to grant accelerated approval to Biogen for its Alzheimer's drug.

Internal agency documents showed a divide among top agency brass regarding the available evidence to support approval. Cavazzoni, in addition to colleagues Peter Marks, M.D., Ph.D., and Richard Pazdur, M.D.—respectively, the directors of the FDA’s biologics evaluation and the oncology center of excellence—supported approval. Subsequent reports that the agency and Biogen had a cozy relationship prompted acting FDA Commissioner Janet Woodcock M.D., to ask the FDA's inspector general to investigate. Cavazzoni did not wade into accelerated approvals or how the budget would affect them in her address Monday.