Executive Summary

FDA GENERIC DRUG GROUP ADDING ANDA REVIEW BRANCH IV to its ranks, bringing the total number of generic drug review branches to five -- four chemistry review branches and one antibiotic branch. A "vacancy announcement" for supervisory chemist of the new branch was posted by FDA Feb. 16 with a closing date of March 1. The agency reportedly intends to hire five review chemists to work in the new generic review branch. Additional recruitment efforts in the generic drug group include the hiring of two new review chemists, Abraham Croitoru and Paul Schwartz, who joined ANDA Review Branch 1 on Feb. 26. The additional review branch is expected to help reduce the backlog of ANDA applications that has been accumulating over the past several months as a result of the generic drug investigation. Recently, the rate of ANDA approvals has come to a near standstill. For example, the agency only approved one ANDA in February, compared to its monthly average of 40-50 prior to the investigation. According to the Office of Generic Drugs, an additional 30 FTEs (full time equivalents) have been allotted to the office for fiscal year 1990. The office says it is "vigorously pursuing recruitment" of new personnel in order to keep up with the growing number of pending ANDAs and supplements. Positions that are open include a director for the office of generic drugs, director of the generic drugs division, consumer safety officers, kineticists, review chemists and support staff. The agency is taking steps to make reviews more fair and efficient in response to recommendations made by the HHS Office of the Inspector General after its audit of the generic review process last summer. The IG had suggested that the agency develop "uniform review procedures and operating guidelines for assigning, reassigning, reviewing and tracking" applications in an efffort to reduce the possibility or appearance of favoritism ("The Pink Sheet" Aug. 28, p. 3). * One area the agency is working on is development of an ANDA review plan that would be modeled in part after the NDA approval process. The agency is considering dividing its ANDA review branches by therapeutic classification and assigning ANDAs to branch reviewers accordingly. At this time, the review branches are not formally organized by classification. Instead, ANDA applications often are assigned to reviewers who have historically handled the particular drug type that is the subject of the application.