FDA GENERIC DRUG APPROVAL AUTHORITY SHIFTED

Executive Summary

FDA GENERIC DRUG APPROVAL AUTHORITY SHIFTED to Center for Drug Evaluation & Research Director Carl Peck and CDER Deputy Director Gerald Meyer. The change was made as part of a realignment of responsibilities resulting from the ongoing investigation into allegations of favoritism in the generic drug review process. Peck outlined the changes, which took effect "immediately," in a May 12 memo to staff in the Division of Generic Drugs and the Division of Bioequivalence. "Authority pertaining to the approval process for abbreviated new drug applications . . . will now be exercised only by myself and Mr. Meyer until further notice," Peck said. Previously, the directors and deputy directors of the Division of Generic Drugs, the Office of Drug Standards and CDER all had authority to sign off on generic drug applications. The approval authority relates to ANDAs, ANDA supplements, ANDA suitability petitions and 5C antibiotic applications. Among the shifts of responsibility, Generic Drugs Division Director Marvin Seife, MD, and Office of Drug Evaluation (ODE) I Deputy Director for Program Management Richard Terselic are temporarily switching positions. "Pending the outcome of our review of information associated with the allegations and charges made against certain members of the staff of these programs, we have temporarily detailed [Seife] to serve as a deputy director in ODE I and have asked Mr. Richard Terselic to serve as acting director of the Division of Generic Drugs," Peck explained. Oncology and Pulmonary Drug Products Division Deputy Director Robert Jerussi is also being detailed to the Division of Generic Drugs in the new position of acting deputy director for chemistry, where he will coordinate chemistry reviews. FDA recently lost two of its generic drug chemists as a result of the Baltimore grand jury investigation: Chemistry Review Branch Chief Charles Chang and Review Chemist David Brancato, who worked under Chang, resigned in late April. The restructuring of responsibilities also calls for the Division of Generic Drugs and the Division of Bioequivalence to report directly to Peck. The divisions formerly reported to the Office of Drug Standards (ODS), headed by Peter Rheinstein. The memo notes that the Division of OTC Drugs and Division of Drug Advertising will continue to report to ODS and that Rheinstein and ODS staff "will be available to consult on matters relating to the generic drug review process."