In a continuing effort to deal with the number of ANDAs, supplements, and bioequivalence work and maintain a consistent and uniform quality of its reviews, the Office of Generic Drugs will be moving forward with a reorganization plan that will likely be effective sometime later in 2021. In the announcement received via email this morning, the Agency said that the reorganization “will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review while upholding FDA’s international reputation as the gold standard in the assessment and monitoring of generic drugs.”
The email noted that “[T]he guiding principles of the reorganization are to improve efficiency and consistency across OGD, and enhance collaboration and operational effectiveness. The reorganization will more effectively resource and support the high volume of generic drug applications FDA receives every year and will support the essential and intricate work of the generic drug program.”
While the notice provided information on the formation of additional divisions in existing OGD offices, it is not clear at this time how the new divisions will operate and how they will fit into accomplishing the OGD’s goals. I am certain we will hear more about this reorganization effort as the time for implementation get closer and activity begins.
The preliminary information, as outlined in the email, is that “[N]ew divisions will be established in existing OGD Offices, including the Division of Bioequivalence Process Management (Office of Bioequivalence), the Division of Therapeutic Performance II (Office of Research and Standards), and the Division of Orange Book Publication and Regulatory Assessment (Office of Generic Drug Policy). Lastly, the Division of Quality Management Systems will move from the Office of Regulatory Operations to become the Quality Management Systems Staff within OGD’s Immediate Office.”
Other than that, we will need to keep an eye out for additional information regarding the operational details as the devil is always in the details!