1. Update from the Office of Generic Drugs Gary J. Buehler, R.Ph. Director, Office of Generic Drugs Center for Drug Evaluation and Research Food & Drug Administration March 2, 2004 Generic Pharmaceutical Association 2004 Annual Meeting

2. Center for Drug Evaluation & Research2 Office of Generic Drugs Full and Tentative Approvals of ANDAs (306)(310)(294)(249)(266)(364)(373)

3. Center for Drug Evaluation & Research3 Office of Generic Drugs

4. Center for Drug Evaluation & Research4 Office of Generic Drugs Receipts of Original ANDA Applications

5. Center for Drug Evaluation & Research5 Office of Generic Drugs

6. Center for Drug Evaluation & Research6 Office of Generic Drugs

7. Center for Drug Evaluation & Research7 Workload Backlog and Staffing Chemistry FY01FY02FY03FY04 Backlog140-150days90-120 days±100 days Staffing 60 (at end of FY) Lost 4 Gained 8 Lost 2 Gained 12 Lost 2 Gained 2 Pending374395506625* Receipts307361449239* * as of 1/31/2004

8. Center for Drug Evaluation & Research8 New Chemistry Review Division Chemistry Division 1 Team 1 Team 4 Team 5 Team 2 Chemistry Division 2 Team 6 Team 9 Team 10 Team 7 Team 3Team 8 Chemistry Division 3 Team 4 Team 6Team +

9. Center for Drug Evaluation & Research9 Workload Backlog and Staffing Microbiology FY01FY02FY03FY04 Backlog (Orig) 210 days343 days280 days86 days* Staffing 4 (at end of FY) Lost TL Gained TL +1 Lost 0 Gained 1 Lost 0 Gained 1 Backlog (Supp) 209 days110 days113 days90 days* Pending121903972* Receipts307361449239* * as of 1/31/2004

10. Center for Drug Evaluation & Research10 Workload Backlog and Staffing Bioequivalence FY01FY02FY03FY04 Backlog±49 days118 days200+ days226 days* Staffing 30 (at end of FY) Lost 4 Gained 0 Lost 2 Gained 5 Lost 0 Gained 2 Pending374395506625* Receipts307361449239* * as of 1/31/2004

11. Center for Drug Evaluation & Research11 Scientific Staff n FY2002 v Lawrence Yu n FY2003 FY2004 - projected v Robert Lionberger  Andre Raw v Sam Haider v Hyojong Kwon v Pradeep Sathe v Qian Li

12. Center for Drug Evaluation & Research12 Clinical Review Staff n FY2002 v Dena Hixon, MD n FY2003 FY2004 - projected v Carol Kim  Additional MD v Krista Scardina v Helen Li (Statistician) v Sarah Ho

13. Center for Drug Evaluation & Research13 Other Activities n Listed Drug Guidance v Directed by new law v Drafted; under review n OGD/Office of Chief Counsel (OCC) determining regulation revisions or changes necessitated by new law n OGD/GPhA Communications

14. Center for Drug Evaluation & Research14 Interaction to Facilitate Efficient Approval of Applications n June 11, 2003 - Impurities - Lawrence Yu n June 26, 2003 - General discussion - Need for dissolution database identified n September 24, 2003 - Webcast on Impurities n October 15, 16, 17, 2003 - Fall Technical Conference n November 5 & 6, 2003 - First “ANDA Basics” Workshop n February 4 & 5, 2004 - Second “ANDA Basics” Workshop n February 10, 2004 - Webcast on cGMP n TO COME: v April 20, 2004 – Preparing CTD/eCTD Workshop

15. Center for Drug Evaluation & Research15 Budget Outlook n FY2004 v Not yet finalized n FY2005 v Proposed the same as FY2004 v Can’t predict what will happen

16. Center for Drug Evaluation & Research16 Bioequivalence Information Availability n Dissolution Methods database v Will be available March 2004 v Will be initially populated with older products v Newly approved products will be added incrementally n In-Vivo Bioequivalence Recommendations database being planned

17. Center for Drug Evaluation & Research17 DRAFT ben

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19. Center for Drug Evaluation & Research19 Orange Book Revisions n Increased staffing to improve service Will go to daily patent listings ≈ April 2004 n New search capability for patent listings from OB webpage

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22. Center for Drug Evaluation & Research22 CDER Electronic Submission Initiatives n Electronic-Common Technical Document v Pilot program has begun v G for I: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions n ANDAs, DMFs, NDAs, BLAs, INDs v Efficient, flexible approach v Uses e-CTD Viewer System (EVS) v Commercial tools available for creating e-CTD

23. Center for Drug Evaluation & Research23 CDER Electronic Submission Initiatives n E-Labeling Submissions v Implementation of a Structured Drug Label v A repository to house all labels v Develop tools to review and keep labels current v FR, February 5, 2004, Docket No. 2004D-0041 v G for I: Providing Regulatory Submissions in Electronic Format – Content of Labeling

24. Center for Drug Evaluation & Research24 E-Submissions/E-CTD Additional information and specifications www.fda.gov/cder/regulatory/ersr/ectd.htm CDER/Office of Information Management ERSR Technical Support: ESUB@CDER.FDA.GOV CTD@CDER.FDA.GOV

25. Center for Drug Evaluation & Research25 For the Future: n Continue to maximize our review efficiency n Continue to focus resources on backlogged review areas n Continue to interact regularly with GPhA to discuss critical issues n Expand the Dissolution Methods database n Create a In-Vivo Bioequivalence Recommendations database

26. Center for Drug Evaluation & Research26

27. Center for Drug Evaluation & Research27 February 11, 2004 n OGD approved 13 applications for Benazepril or Benazepril/HCTZ n 2002 Sales for Lotensin ® (the RLD) were $315 million (ranks 97 th ) n In one week, the retail price of a month’s supply of Benazepril fell from $44 to $26 (40% decrease) n Approximate annual savings of 100 million dollars

28. Center for Drug Evaluation & Research28 Final Words... n The generic drug industry has done more to address the spiraling health costs in this country than any other industry n More than 50% of all prescriptions dispensed are supplied by your industry and reviewed by my office WW e are making a difference...

29. Center for Drug Evaluation & Research29 Office of Generic Drugs