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FDA Launches Overhaul of New Drug Review Program


Pressure to assess and approve a growing volume of promising new drugs and biologics in accelerated timeframes is prompting a major reorganization of CDER's Office of New Drugs.

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 a plan to increase OND’s drug review offices from 5 to 9 and to expand specific review divisions from 19 to 30. Likely changes are to split OND’s hematology division into two units and to divide the gastroenterology team into three groups. Additional divisions would focus on diabetes, obesity products, and ophthalmology.

Such structural changes would “ultimately flatten the overall matrix of our review process,” observed FDA commissioner Scott Gottlieb, in a statement supporting the OND reorganization. The creation of more new therapeutic-specific divisions will promote more efficient reviews, he said, while also deepening internal collaboration and enhance external scientific exchange.

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 percent 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 commented at the recent meeting of the American Society of Clinical Oncology (ASCO). He described a number of innovations FDA is piloting to accelerate the review and approval of applications and supplements for cancer therapies. FDA’s Oncology Center of Excellence (OCE) is implementing a real-time oncology review of data strategy to support added indications for already approved cancer drugs. These and other new efficiencies to the oncology review process should lead to broader improvements in oversight for all new drugs.


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