Office of Generic Drugs updates key leadership positions
WASHINGTON — The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced. OGD has made assignments, most of which are in an acting capacity, to key OGD subordinate office leadership positions in preparation for Oct. 1 — the beginning of Year 3 of GDUFA when GDUFA goal dates go into effect.
Rob Lionberger will lead the Office of Research and Standards, or ORS, which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling. John Peters will lead the Office of Bioequivalence, or OB, which includes the three Divisions of Bioequivalence and the Division of Clinical Review. Jason Woo will lead the Office of Regulatory Operations, or ORO, which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems. Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy, or OGDP, which includes the Division of Policy Development and the Division of Legal and Regulatory Support. Kathleen “Cook” Uhl, M.D. will remain in her current role as acting director of OGD.
According to the FDA, these changes will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review. It also will provide higher visibility within the Center and Agency to address generic drugs challenges, and better positions OGD to maximize its efficiency in meeting GDUFA requirements, as demonstrated by the formation of an Office of Research Standards and an Office of Generic Drug Policy.
Generic drugs make up nearly 85% of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on the FDA to ensure that generic drugs perform clinically in the same way as their brand-name counterpart drugs. Transforming OGD into a super office was a critical and necessary step in recognizing the importance of generic drugs to public health and the national economy, the agency said.