Gottlieb Proposes Modernization of Drug Review Office

On June 4, 2018, FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research (CDER) would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”

Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.

“We believe that part of these modernization efforts will be enabled through increased organizational efficiency and possible structural changes that would ultimately flatten the overall matrix of our review process. As part of this effort, for example, we’re considering creating many new therapeutic-specific divisions that’ll have more ability to engage in discrete areas of medicine,” Gottlieb stated. “The goal is to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups. We believe this will deepen internal collaboration and enhance external scientific exchange.”

Gottlieb anticipates better organization of the review process and the development of key review memos will make documentation of medical staff findings more efficient so that staff can spend more time on advancing scientific work. The commissioner believes this “new alignment” will improve efficiency by at least 20%. “The goal is to make sure that we continue to fulfill our mission and meet the aspirations of patients, and protect and promote the public health,” Gottlieb stated.

Source: FDA