Plan to reorganize FDA's Office of Generic Drugs receives approval

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, of which the OGD is a part, said the elevation of the office meant it would house subordinate offices within its organizational structure and would report directly to her, with acting director Kathleen Uhl continuing in that role. Woodcock said the reorganization, plans for which were originally announced in September 2012, would strengthen the OGD's operations and allow it to "meet the evolving needs of generic drug review."

"Transforming OGD into a super office is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy," Woodcock wrote. "As a super office, OGD will coordinate and manage the abbreviated new drug application review process, provide safety, surveillance, clinical and bioequivalence reviews for generic products, as well as contain new offices to develop policy and regulatory science for generic drugs."

The new structure of the OGD will include an Office of Research and Standards, an Office of Bioequivalence, an Office of Generic Drug Policy and an Office of Regulatory Operations, each of which will have multiple divisions under it. Members of a transition team will lead the offices.