# Presentation: 694868

## 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

## Slide 2

- Center for Drug Evaluation & Research

## Office of Generic Drugs

- Center for Drug Evaluation & Research

## Office of Generic Drugs

**Receipts of Original ANDA Applications**

- Center for Drug Evaluation & Research

## Office of Generic Drugs

- Center for Drug Evaluation & Research

## Office of Generic Drugs

- Center for Drug Evaluation & Research

## Workload Backlog and Staffing

| Chemistry | FY01 | FY02 | FY03 | FY04 |
| --- | --- | --- | --- | --- |
| Backlog | 140-150days |  | 90-120 days | ±100 days |
| Staffing | 60 
(at end of FY) | Lost 4
Gained 8 | Lost 2
Gained 12 | Lost 2 Gained 2 |
| Pending | 374 | 395 | 506 | 625* |

| Receipts | 307 | 361 | 449 | 239* |
| --- | --- | --- | --- | --- |

- *as of 1/31/2004

- Center for Drug Evaluation & Research

## 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 3

- Team 8

**Chemistry Division 3**

- Team 4

- Team 6

- Team +

- Center for Drug Evaluation & Research

## Workload Backlog and Staffing

| Microbiology | FY01 | FY02 | FY03 | FY04 |
| --- | --- | --- | --- | --- |
| Backlog (Orig) | 210 days | 343 days | 280 days | 86 days* |
| Staffing | 4
(at end of FY) | Lost TL
Gained TL +1 | Lost 0
Gained 1 | Lost 0 Gained 1 |
| Backlog (Supp) | 209 days | 110 days | 113 days | 90 days* |
| Pending | 121 | 90 | 39 | 72* |

| Receipts | 307 | 361 | 449 | 239* |
| --- | --- | --- | --- | --- |

- *as of 1/31/2004

- Center for Drug Evaluation & Research

## Workload Backlog and Staffing

| Bioequivalence | FY01 | FY02 | FY03 | FY04 |
| --- | --- | --- | --- | --- |
| Backlog | ±49 days | 118 days | 200+ days | 226 days* |
| Staffing | 30 
(at end of FY) | Lost 4
Gained 0 | Lost 2
Gained 5 | Lost 0 Gained 2 |
| Pending | 374 | 395 | 506 | 625* |

| Receipts | 307 | 361 | 449 | 239* |
| --- | --- | --- | --- | --- |

- *as of 1/31/2004

- Center for Drug Evaluation & Research

## Scientific Staff

- FY2002
- Lawrence Yu
- FY2003	FY2004 - projected
- Robert Lionberger		 Andre Raw
- Sam Haider
- Hyojong Kwon
- Pradeep Sathe
- Qian Li

- Center for Drug Evaluation & Research

## Clinical Review Staff

- FY2002
- Dena Hixon, MD
- FY2003	FY2004 - projected
- Carol Kim		 Additional MD
- Krista Scardina
- Helen Li (Statistician)
- Sarah Ho

- Center for Drug Evaluation & Research

## Other Activities

- Listed Drug Guidance
- Directed by new law
- Drafted; under review
- OGD/Office of Chief Counsel (OCC) determining regulation revisions or changes necessitated by new law
- OGD/GPhA Communications

- Center for Drug Evaluation & Research

## Interaction to Facilitate Efficient Approval of Applications

- June 11, 2003 - Impurities - Lawrence Yu
- June 26, 2003 - General discussion - Need for dissolution database identified
- September 24, 2003 - Webcast on Impurities
- October 15, 16, 17, 2003 - Fall Technical Conference
- November 5 & 6, 2003 - First “ANDA Basics” Workshop
- February 4 & 5, 2004 - Second “ANDA Basics” Workshop
- February 10, 2004 - Webcast on cGMP
**TO COME:**
- April 20, 2004 – Preparing CTD/eCTD Workshop

- Center for Drug Evaluation & Research

## Budget Outlook

- FY2004
- Not yet finalized
- FY2005
- Proposed the same as FY2004
- Can’t predict what will happen

- Center for Drug Evaluation & Research

## Bioequivalence Information Availability

- Dissolution Methods database
- Will be available March 2004
- Will be initially populated with older products
- Newly approved products will be added incrementally
- In-Vivo Bioequivalence Recommendations database being planned

- Center for Drug Evaluation & Research

## DRAFT

*DRAFT*

- ben

- Center for Drug Evaluation & Research

## Slide 18

- Center for Drug Evaluation & Research

## Orange Book Revisions

- Increased staffing to improve service
- Will go to daily patent listings  ≈April 2004
- New search capability for patent listings from OB webpage

- Center for Drug Evaluation & Research

## Slide 20

- Center for Drug Evaluation & Research

## Slide 21

- Center for Drug Evaluation & Research

## CDER Electronic Submission Initiatives

- Electronic-Common Technical Document
- Pilot program has begun
- G for I: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions
- ANDAs, DMFs, NDAs, BLAs, INDs
- Efficient, flexible approach
- Uses e-CTD Viewer System (EVS)
- Commercial tools available for creating e-CTD

- Center for Drug Evaluation & Research

## CDER Electronic Submission Initiatives

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

- Center for Drug Evaluation & Research

## 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

- Center for Drug Evaluation & Research

## For the Future:

- Continue to maximize our review efficiency
- Continue to focus resources on backlogged review areas
- Continue to interact regularly with GPhA to discuss critical issues
- Expand the Dissolution Methods database
- Create a In-Vivo Bioequivalence Recommendations database

- Center for Drug Evaluation & Research

## Slide 26

- Center for Drug Evaluation & Research

## February 11, 2004

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

- Center for Drug Evaluation & Research

## Final Words...

- The generic drug industry has done more to address the spiraling health costs in this country than any other industry
- More than 50% of all prescriptions dispensed are supplied by your industry and reviewed by my office

- We are making a difference...

- Center for Drug Evaluation & Research

## Office of Generic Drugs

- Center for Drug Evaluation & Research