Office of Generics Drugs reorganizes for greater efficiency

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office’s ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA.

The organization adds another division to both the bioequivalence and chemistry programs, and converts the microbiology and clinical review staffs into divisions. It also formalizes the position of Deputy Director for Science and Chemistry. Here is the new structure:

Division of Bioequivalence I
Division of Bioequivalence II
Division of Labeling and Program Support
Division of Microbiology
Division of Clinical Review
Division of Chemistry I
Division of Chemistry II
Division of Chemistry III
Division of Chemistry IV

The reorganization is a major step in CDER's efforts to advance the public health as the use of generic drugs continues to increase.

“Key changes net down to adding another division to both the bioequivalence and chemistry programs-a key to solving backlog, and converts the microbiology and clinical review staffs into divisions while formalizing the position of Deputy Director for Science and Chemistry,” Randy Vogenberg, PhD, said. Vogenberg is principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia.

“This allows FDA to bulk up staffing to deal with backlog as well as finalizing market approvals for generics while establishing more structure to this part of the agency,” added Vogenberg, who is the author of Pharmacy Benefits: Management and Benefit Design, published by IFEBP. “Whether or not the new structure will gain all the efficiencies will take time to tell.”