Overhaul of New Drug Approval Process Moves Forward

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), aims to start implementing new review practices in the Office of New Drugs (OND) by the end of 2018 and to stand up a new OND structure by the summer of 2019, but has to overcome numerous hurdles in the process. A first order of business is to select a new OND director, she told members of the Alliance for a Stronger FDA at a recent briefing, a position that Woodcock has assumed temporarily while the reorganization process has proceeded.

A main challenge in expanding the drug review operation is to fully staff the organization. CDER currently has approximately 1000 staff openings of about 6000 full-time employees, a situation that requires the agency to contract out numerous operations and tasks. CDER also seeks to further automate and modernize inefficient review data systems. Establishing a new framework for improved “knowledge management” is “not that sexy,” Woodcock observed. But with drug development involving a huge expansion in information through wider collection of real-world evidence, patient reported outcomes, genomic data and reports from registries, CDER will be “bombarded by data,” she noted.

A new IT platform able to put “all this vast information at the fingertips of reviewers” is critical, she said, and will lead to better informed regulatory decisions. Woodcock also aims to improve the review process by forming cross-disciplinary teams for each new drug application (NDA), instead of leaving it to individual reviewers to consult with additional specialists. At the same time, OND will have a centralized project management operation to ensure that all review divisions follow a consistent review process.

The reorganization of OND takes longer than revising internal review processes, as such operational changes require review and approval by the Department of Health and Human Services, by the Office of Management and Budget, and by Congress. To enhance CDER’s ability to meet tight timeframes for a growing volume of work, Woodcock seeks to increase the number of review offices from five to nine, which will contain 30 review divisions, up from 19. The result will be more specialized units that better understand the diseases being treated by proposed drugs. For example, hematology will be separate from cancer, which now is managed by FDA’s Oncology Center of Excellence.

One thing that Woodcock opposes is the creation of additional centers of excellence for difference diseases areas, such as cardiovascular, neurology, and rare diseases. Patient groups and research organizations all want their own centers, noted the CDER director, but she expressed skepticism that such a change would be beneficial. OND strives to ensure that there is consistency in policy, research standards, and review policies and to avoid duplication and inconsistencies among FDA medical product centers, a process that involves a complex matrix structure. “You can’t just make more Centers of Excellence and hope they work,” she commented. And instead of a new center of excellence for rare diseases, as patient groups have requested, she is proposing that the new OND will have a division for rare diseases.

These organizational and operational changes in CDER are supported by additions to the Center’s management team. At the briefing, Woodcock introduced Patrizia Cavazzoni, deputy center director for operations, who is involved in implementing OND modernization, and Gary Mays, CDER executive officer in charge of administrative management operations, including finances and facility management.