New Director Tapped to Head FDA’s Office of Generic Drugs

By Kurt R. Karst –

FDA’s Office of Generic Drugs (“OGD”) will have a new leader beginning next week.  On July 13th, Helen Winkle, Director of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research, in which OGD is housed, announced that Gregory P. Geba, M.D., M.P.H. has been named OGD Director.  Dr. Geba will replace Dr. Keith Webber, who has served as OGD’s Acting Director since the departure of Gary Buehler in 2010.  During that time, Dr. Webber has also served as Deputy Director of the Office of Pharmaceutical Science. 

The announcement comes just days after the enactment of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) as part of the FDA Safety and Innovation Act (see here).  GDUFA significantly revamps the generic drug approval process and will have wide-ranging effects on industry and on OGD.  Below is the correspondence from Ms. Winkle announcing Dr. Geba’s selection.

The Office of Pharmaceutical Science (OPS) is proud to announce the selection of Gregory P. Geba, M.D., M.P.H., as Director of the Office of Generic Drugs (OGD) effective July 15, 2012.
 
Dr. Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He most recently served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.
 
He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.
 
Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office’s ability to ensure that all generic drugs—which make up nearly 80 percent of prescriptions filled in the United States—are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.
 
Please join me in welcoming Dr. Geba to this important position. We welcome the wealth of knowledge and experience that he will bring to the organization.