
FDA Launches Overhaul of New Drug Review Program
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
Pressure to assess and approve a growing volume of promising new drugs and biologics in accelerated and compressed timeframes is prompting a major reorganization of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). The aim is to help CDER staff deal with a “staggering pace of work,” that involves attention to detail and the need to keep up with emerging scientific advances in genomic medicine, targeted therapy, digital health, drug-device combination, and more global drug development, commented CDER director Janet Woodcock. She has been spearheading the initiative for the past year, with an eye on encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
In announcing the pending reorganization last week, Woodcock outlined
Such structural changes would “ultimately flatten the overall matrix of our review process,” observed FDA Commissioner Scott Gottlieb, in a
Each new drug application, moreover, will be reviewed by a cross-disciplinary team comprised of OND reviewers plus experts from CDER’s Office of Translational Sciences, Office of Surveillance and Epidemiology, and Office of Pharmaceutical Science. Additional staff from field inspection and compliance offices also may be involved. OND also will form a centralized project management function to establish a single, consistent review process for all divisions. Enhanced IT systems will improve access to information that can support scientific reviews and help ensure consistent regulatory decisions. And a more uniform post-market safety surveillance framework will better monitor the benefits and risks of drugs before and after approval.
Implementing this reorganization will entail expanding OND’s staff, a process enhanced by provisions in the 21st Century Cures legislation. An important benefit of the proposed reorganization, Woodcock emphasizes, is that CDER scientists and physicians would gain more time to collaborate with external researchers, physicians, and patient communities to better inform drug development and oversight.
Gottlieb similarly emphasized the role of FDA scientists and medical officers in dealing with new adaptive approaches to clinical development and to processes for evaluating new medical products. He highlighted the importance of providing review staff with more time to provide feedback to sponsors on clinical protocols and development processes and to engage with researchers and patient groups in identifying risks and benefits of new therapies. He estimated that the new staff alignment and review processes will “improve efficiency by 20% at a minimum” due to better workflow and workforce management and greater internal collaboration across review functions.
Maintaining a speedy, efficient new drug review process is vital for FDA to be able to spur innovation and bring new breakthrough therapies to patients, Gottlieb
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