Reorganization of FDA’s Office of the Commissioner to Begin Soon
Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND).With an eye toward efficiency and better connecting the Office of the Commissioner with center directors and other office leadership, outgoing FDA Commissioner Scott Gottlieb said in an email to staff on Thursday that the reorganization plan “elevates the role of the Centers in support of FDA’s science-driven culture, consolidates work in the Office of Operations to more effectively support the Agency’s mission and strengthens our staffing and recruiting functions.”
Two major changes include the creation of the Office of Product Evaluation and Quality within the Center for Devices and Radiological Health (more details can be found here), and the creation of the Office of Therapeutic Biologics and Biosimilars (OTBB) within OND.
Implementation of the reorganization across the centers will be rolled out in phases, Gottlieb added.
According to an email from Center for Drug Evaluation and Research (CDER) Director Janet Woodcock to staff, the OTBB will house policy and scientific review staff and realign staff from the OND Immediate Office to OTBB.
“The increasing complexities and visibility of this program require a dedicated office to efficiently and effectively achieve cross-organizational coordination and collaboration – and advance policy development for these products,” Woodcock said.
In addition to creating OTBB, OND’s Office of Hematology and Oncology Products (OHOP) will establish a third oncology division, a second hematology division, a division of regulatory affairs and centralized safety reporting and labeling teams.
CDER’s Office of Compliance will also see organizational changes affecting several of its offices as part of efforts to advance its compounding program and better shield patients from poor-quality, unsafe and ineffective drugs through compliance and enforcement.
Changes in the Office of Executive Programs, meanwhile, will establish four staff groups within the Immediate Office focusing on special projects, executive secretariat matters, legislative activities and program management and analysis – absorbing the functions of the former Division of Executive Operations.
The restructuring also establishes two branches within the Division of Advisory Committee and Consultant Management to manage and oversee advisory committees and conflicts of interest.
And in the Office of Communications, the Division of Health Communications will become the Division of Public Education and Outreach, and the Division of Online Communications will become the Division of Digital and Online Communication.