# Presentation: 000982

## Office of Generic DrugsDirector’s Update

- Gary J. Buehler, R.Ph.
- Director
- June 26, 2003

***Generic Pharmaceutical Association/FDA Meeting***

## Topics

- Workload
- Priorities
- Goals
- Plans

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Slide 3

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Slide 4

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Slide 5

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Slide 6

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Slide 7

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Controlled Correspondence

- Same reviewers that review ANDAs respond to Controlled Correspondence
- We realize there is a backlog
- Many firms submit multiple requests
- We are hiring new reviewers but it could take some time to clear backlog

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Dispute Resolutions

- Informal
- Within division
- Division Director
- Office Director
- Formal
- Per guidance

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Commissioner’s Priorities

- Improve efficiency of review process
- Increase early communication (during first cycle)
- Provide additional guidance for preparing quality, complete applications

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Commissioner’s Priorities (cont’d.)

- Increase number of first cycle approvals
- Decrease the total time to approval
- Hasten generic products to market

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Resource Increase

- $13 million proposed for FY04
- Hire 40 new reviewers
- Initiate targeted research
- Improve the efficiency of the review process

- Office of Generic Drugs

- U.S. Food & Drug Administration

## OGD Generic Drug Quality Awareness Program

- Help consumers get accurate information about generic drugs
- Ensure that consumers are aware that FDA-approved generic drugs are safe, effective  and bioequivalent to “brand name” counterpart
- Counter the existing bias against generic drugs

- Office of Generic Drugs

- U.S. Food & Drug Administration

## OGD Goals

- GPRA (Govt. Performance & Results Act)
- Percent of original applications acted upon within 180 days
- Not compatible with achieving 1st cycle approvals
- OGD has met goal very successfully

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Short Term Plans...

- Meet regularly with GPhA to discuss timely issues
- Improve communication during the review process
- Hire and train more reviewers

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Long Term Plans...

- Look critically at our review process
- Identify where possible, avenues to expedite generic approvals, especially for first generics
- Initiate research programs to address inadequate or onerous BE methods for certain products

- Office of Generic Drugs

- U.S. Food & Drug Administration

## Conclusion

- We want to work with the generic industry
- We want to identify where we can improve
- We recognize the work invested in your applications

- Office of Generic Drugs

- U.S. Food & Drug Administration

## We, at OGD, are very proud of the role we play, as the generic industry should be proud of the role they play, in making quality, lower cost drugs available.

- Office of Generic Drugs

- U.S. Food & Drug Administration