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U.S. Department of Health and Human Services

For Industry

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ADUFA: What it Means for the Small Company

PowerPoint Version

Slide 1

ADUFA: What it Means for the Small Company

Kristi Smedley

ADUFA: What it Means for the Small Company Slide 1

Slide 2

Small Companies

  • New Companies that have No Existing Marketed Drug Products
  • Established Companies that have Existing Products but NO New Drug Development
ADUFA: What it Means for the Small Company Slide 2

Slide 3

INAD Holders without any Marketed Product

Companies that are investigating potential new animal drugs must pay sponsor fees.
The investigational period may take many years, without any return.

ADUFA: What it Means for the Small Company Slide 3

Slide 4

ADUFA FEES
Level Playing Field?

Should the ADUFA fees be leveled as related to number of products:
- Firm with two marketed NADAs-no new development: $104,430
- Firm with 20 marketed NADAs-no new development: $178,500
*The Sponsor and Establishment Fee are a significant amount of these fees (96K).

ADUFA: What it Means for the Small Company Slide 4

Slide 5

NADAs Filed

  • 2003 (3 yr Avg) 23
  • 2005 (2 yr Avg) 18
  • 2006 (3 yr Avg) 13
  • Has ADUFA stopped the Filing of Potential NEW animal Treatments? (In the same period Investigational Protocols have dropped 27%.)
ADUFA: What it Means for the Small Company Slide 5

Slide 6

Considerations

Are User Fees Benefiting the Animal Industry?

    • Are they Stifling Development of New and Innovative Treatment?
    • Are they providing a disincentive for any new animal pharmaceutical firms?
    • Are they pushing more of the “drug-like” products out of the traditional animal drug approval process into the “drugs of low regulatory priority” or marketing under the FDA radar?
    • Could this process beget human food safety issues?
ADUFA: What it Means for the Small Company Slide 6

Slide 7

Considerations-continued

  • Can Animal Drug User Fees Be Eliminated?
  • Can Sponsor Fees be Eliminated, so that the fees are related to REAL COSTS (preapproval or post-approval reviews)
  • Eliminate User Fees for Sponsors that have NO marketed Animal Drug Product. (Cover INAD costs once the NADA is submitted.)
  • Modify Law so an “Up Front” reduction of fees is used rather than the post-payment option—Especially for those with NO new applications.
ADUFA: What it Means for the Small Company Slide 7

Slide 8

Potential Changes

  • Eliminate Animal Drug User Fees.
  • Modify the User Fee coverage to exempt firms without ANY marketed new animal drugs.
  • Provide FDA with more discretion to exempt or lower user fees with just cause.
  • Scale Fees to sales volume/plant size/gross income.
  • Eliminate Sponsor Fees and Base only on the marketed products.
ADUFA: What it Means for the Small Company Slide 8

Slide 9

Conclusion

FDA Should Not Support A Continuation of
ADUFA 2003.

ADUFA: What it Means for the Small Company Slide 9