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ANDA APPROVAL SIGN-OFF AUTHORITY PASSED FROM CDER DIRECTOR PECK

Executive Summary

ANDA APPROVAL SIGN-OFF AUTHORITY PASSED FROM CDER DIRECTOR PECK to the new acting director of FDA's Office of Generic Drugs, Bruce Burlington, MD, and Acting Deputy Director Nicholas Fleischer in a Nov. 3 memo from Peck. The internal FDA announcement comes exactly one month after the acting appointments of Burlington and Fleischer to head the newly-created Office of Generic Drugs. Last May, Center for Drug Evaluation and Research Director Carl Peck and CDER Deputy Director Gerald Meyer took on the added responsibility for signing off on ANDA approvals. The decision was made as part of a general realignment of generic drug division responsibilities in response to revelations that several ANDA reviewers had accepted illegal gratuities from generic drug company executives. "Now that we have established an Office of Generic Drugs and Dr. Burlington and Mr. Fleischer have been collaterally assigned as the acting director and acting deputy director for bioequivalence, respectively, I want to delegate authorities to them so they may carry out their responsibilities," Peck stated in the Nov. 3 memo. Peck noted that a formal announcement will be published in the Federal Register. The authorities passed on to Burlington and Fleischer include sign-off responsibilities for citizens petitions, ANDAs, ANDA supplements, and 5-C NDAs as well as authority to determine ANDA submission dates and dates of effective approval. Peck said that Burlington and Fleischer would "have the same authority as permanent officials would have." Peck indicated that he would still like to keep his hand in the decisionmaking process in the Office of Generic Drugs. The memo notes: "I have asked Dr. Burlington and Mr. Fleischer to continue to discuss with me those actions that, in their judgement, involve a particular scientific or sensitive policy issue that they believe should have my personal attention." The internal announcement is an indication of the activity at FDA in preparation for Commissioner Young's upcoming appearance before Rep. Dingell's (D-Mich.) Energy & Commerce/Oversight Subcommittee on Nov. 17. Young is expected to provide an update on FDA's efforts to revamp its generic drug approval procedures. The creation of the Office of Generic Drugs and the management reorganization have been priority items in the agency's damage control for the generic scandal. The industry will be watching now to see if the rate of ANDA approvals picks up from the trickle of new generics that have come out of the agency in the past six months. In the month of October, FDA approved only two ANDAs.

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