FDA Gains Approval to Revamp New Drug Review Operations

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs. In the works for nearly two years, this effort to modernize and reorganize CDER’s Office of New Drugs (OND) establishes additional new drug review offices and divisions more aligned to assess therapies for interrelated diseases and conditions. In addition, new administrative offices aim to better manage policy development and program management. The new structure “will strengthen operations in a number of CDER offices,” said Woodcock, and “promote a more efficient review process,” with “stronger alignment of administrative, regulatory project management, program operations, policy and drug development tool services.” 

Under the new structure, an OND deputy director for clinical operations will oversee eight (up from six) offices with 27 review divisions (vs. 19 divisions now). The aim is to better align staff expertise with more defined therapeutic areas, while also reducing workloads so that scientists and physicians can better respond to changes in biomedical science. The new Office of Oncologic Diseases expands to five review divisions, while neuroscience is separate from cardiology. There’s a new division for rare diseases and medical genetics, and a new Office of Nonprescription Drugs, but with limited staff pending Congressional approval of a new user fee program in this area. The clinical review offices will work more closely with relevant divisions of clinical pharmacology/toxicology from CDER’s Office of Translational Sciences (OTS). And all these groups will be linked to a new Office of Drug Evaluation Sciences with divisions for clinical outcomes assessments and biomarker qualification and biomedical informatics. 

To further reduce the need for medical reviewers to spend time dealing with administrative tasks, new OND cross-functional support offices for regulatory operations, program operations, and administrative operations will manage business functions, financial accounts and with regulatory developments. The Office of New Drug Policy will lead the development and publication of new guidance documents and regulations. And an Office of Therapeutic Biologics and Biosimilars will oversee policy and product development in this high-profile field. 

CDER’s Office of Pharmaceutical Quality (OPQ) will experience structural changes to better align with the new review structure. This includes establishing a new Office of Administrative Operations and renaming two existing offices and creating seven new divisions to fit the assessment of the chemistry, manufacturing and controls aspects of new drug applications (NDAs) to OND offices and divisions. 

For manufacturers with applications already filed and under review, CDER officials say there will be no changes in review teams, although the name of the responsible division may shift, depending on where a submission stands in the review process. FDA anticipates it will be updating policies and procedures to clarify new division names and processes and promises to regularly communicate with industry about new points of contact. The plan is to have the new structure fully established by early next year. For additional background and information on these changes, see CDER’s webpage.