Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), is behind the changes. By changing how FDA staff are hired, collaborate and share knowledge, Woodcock thinks she can modernize CDER and facilitate the development of safe, effective treatments for unmet medical needs.
“These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly,” said Woodcock.
Woodcock plans to pull multiple levers to achieve these goals. Some of the changes will affect the structure of CDER, for example by increasing the number of review divisions from 19 to 30. Others will instigate the involvement of cross-disciplinary teams throughout new drug applications to more closely integrate FDA experts.
The changes are intended to narrow the therapeutic focus of the FDA’s divisions and free up staff to engage earlier with sponsors. The agency sees these engagements helping sponsors to design trials that efficiently assess the risks and benefits of therapies.
FDA staff will also benefit from investments the agency plans to make in IT capabilities. Specifically, the FDA wants to create a system to store and manage knowledge accrued by its staff.
Woodcock envisages the system giving staff access to historic information that informs current and future reviews. This could make regulatory decision making more efficient.
Gottlieb’s involvement
The proposals chime with comments FDA commissioner Scott Gottlieb made to US politicians in April. Seeking to justify a proposed a 13% bump in funding for the FDA, Gottlieb talked up investments the agency is making in its knowledge management system and their potential to make the drug review process more efficient.
Gottlieb returned to the theme in a statement released alongside Woodcock’s comments.
“We believe the new alignment and processes will improve efficiency by 20% at a minimum overall,” said Gottlieb. “This is, in part, the result of better workflow and workforce management and greater internal collaboration across the different review functions.”
Gottlieb and Woodcock’s comments suggest the FDA’s leadership is on board with the plan. However, the agency will need to gain the backing of other parts of government before enacting the strategy.