# Presentation: 225607

## Generic Animal Drug Alliance(GADA)

**An independent professional trade organization representing animal health industry interests before the FDA and Congress. **

## Member Companies

- AgriLabs, Ltd.
-    AmPharmCo., American Animal Health, Inc.
- Bimeda Animal Health, Inc.
- First Priority, Inc.
- Gaddy & Associates
-   IVX Animal Health, Inc.
- Ivy Animal Health, Inc.
- Lloyd, Inc.
- Med-Pharmex, Inc.
- Norbrook, Inc.
- PRN Pharmacal/Trophy Animal Health
- Putney, Inc.

## Why are we interested?

- Estimate that our member companies pay 10% of the current fees collected through ADUFA, >$1 million/year.
- Member companies currently sponsor or are pursuing both NADAs and ANADAs; review times for both have been impacted by ADUFA.
- GADA is partnering with CVM in the pursuit of legislation for user fees for ANADAs.
- We represent a clear majority of the industry sponsors of abbreviated applications.

## ADUFA’s Impact – Review Times for Generic Applications

- Quote directly from the legislation:
- 	‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.—The Secretary shall—
- 	‘‘(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications, and
- 	‘‘(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.’’

## ADUFA’s Impact – Review Times for Generic Applications

- Separate review team was created for generics in the Division of Manufacturing Technologies.
- Despite maintaining the same number of FTEs in generic application review, review cycles for ANADAs are currently > 450 days. Well above the pre-ADUFA review times.
- Staff dedicated to the review of generics is locked in to the level assessed in 2003, while the number of generic applications continues to climb.

## ADUFA’s Impact

- Since the inception of ADUFA, the resources available for review of **pioneer** products has increased – while the number of submissions has decreased = more resources, fewer approvals.
- Since the inception of ADUFA, the resources available for review of **generic** products has remained the same, while the number of submissions has increased = flat resources, more work.

## ADUFA’s Impact - Perception

- Are fewer products reaching the end user, despite the increase in number of reviewers and resources available to CVM?
- User fees (as currently implemented) may have created a barrier to entry for pioneer products, and at the same time limited resources for review of generic products.
- The resource baseline established for the review of abbreviated applications was inadequate to maintain review times at pre-ADUFA levels.

## ADUFA’s Impact – Industry Wide

- Review times appear to be meeting performance goals on user fee activities.
- Guidance Documents, Policy and Procedure documents appear to be progressing more quickly.
- Fees continue to increase due to the decreasing # of applications and product registrations.

## ADUFA’s Impact – Industry Wide

- Withdrawing applications has become a business strategy!
- Fee structure is especially punitive to small business and private label distribution.
- Fees are an uncertain barrier to market entry. The current framework could ultimately hinder competition and innovation.

## Necessary Changes – ADUFA II

- New resource baselines. Congressional appropriations marked for generic review and pioneer review should be re-evaluated to account for the shift in review workload from pioneer submissions to generic submissions.
- Strive to achieve the legislated goal “ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.’’

## Necessary Changes – ADUFA II

- NAS/NRC/DESI NADAs should be exempted from user fees.
- Annual Sponsor fee should be pro-rated on number of applications held.
- Increased exemptions for small business.
- A User Fee program specific for the generic review process is necessary as inflation continues to erode resources devoted to generic review.

## Conclusion

- GADA supports ADUFA for certain types of applications.
- Many of our member companies do pay fees under ADUFA, and have noted improved review times.
- GADA is encouraged that ADUFA will set a framework for a similar, but separate, User Fee program for the generic review process.

## Generic Animal Drug Alliance

**Contact Us:**
**Edward John Allera**
**Buchanan Ingersoll, PC**
**(202)452-7985**
**Edward.allera@bipc.com**