FDA Moves to Overhaul New Drug Review Process

To better manage a growing number of applications for new drugs that treat disease in innovative ways and involve new kinds of clinical research programs, FDA officials are mapping plans to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). A main goal is to “flatten the organization,” explained CDER director Janet Woodcock, with more reviewers authorized to make decisions on review findings. This shift to smaller review divisions should reduce bottlenecks in the review process, she explained at the annual meeting of the Food and Drug Law Institute (FDLI) last week in Washington, DC. An OND reorganization steering committee heads up the effort, and, she emphasized, the review program modernization effort is “proceeding according to plan.”

Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.

“We want it to be easier to innovate the way drugs are developed,” Gottlieb commented. Our professional staff members are “thought leaders in their disciplines,” he observed, “and we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development.”

New templates

The process for documenting reviews will be revised to highlight issues and data of greatest importance, while also reducing the sometimes redundant memos generated by multiple review processes. Woodcock noted that CDER staffers are developing a new template for documenting multiple aspects of a review, including toxicology, clinical pharmacology, and clinical review.

A new Office of Policy in OND will play a key role in developing more consistent policies and procedures across disease areas, Woodcock added. This office will facilitate the development of more “bullet guidances” that provide short, timely advice on specific topics involved in developing certain therapies. Such guidances are faster to draft and to finalize, and CDER hopes to issue 30–40 such advisories a year.

Gottlieb further described the OND changes at the annual meeting of the Reagan-Udall Foundation the next day, noting that he expects CDER to begin unveiling these initiatives by the end of this summer. The OND reorganization will establish more focused therapeutic divisions, he explained, such as separating the current Division of Gastroenterology and Inborn Errors Products into divisions for gastroenterology and for liver disease. He also anticipated that a common review template would reduce the multiple memos developed by each review discipline.

Such a broad and complex reorganization of this important CDER operation, involving the formation of new review divisions and a new policy office, will take time to move through the formal federal government review process, Woodcock pointed out. Yet, she and her staff have orchestrated such restructuring efforts for generic drugs and for drug quality oversight in recent years, and she anticipates a similarly successful modernization effort for the new drug review process.