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U.S. Department of Health and Human Services

For Industry

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ADUFA Public Meeting

PowerPoint Version

Slide 1

ADUFA Public Meeting

Animal Health Institute
April 24, 2007
Richard Carnevale, VMD
VP, Regulatory, Scientific and International Affairs

ADUFA Public Meeting Slide 1

Slide 2

Why AHI pursued ADUFA

  • Backlog of overdue submissions was more than 2 years old.
  • Average review times were 2-3 times longer than CVM timeframes.
  • Lack of predictability of review process was stifling innovation.
  • AHI was aware that CVM required more resources and more stable appropriations devoted to New Animal Drug Evaluation.
ADUFA Public Meeting Slide 2

Slide 3

Critical Need for Animal Specific Medicines

  • In the US:
    - 8.5 billion chickens and turkeys
    - 160 million cattle and pigs
    - 130 million dogs and cats/9 million horses
  • Human drugs are not developed for an animal species’ physiologic or metabolic makeup, dosing limitations, and sometimes unique disease processes.
  • Veterinarians need medications developed, formulated, and tested specifically for animals.
ADUFA Public Meeting Slide 3

Slide 4

Ultimate Goals of ADUFA

  • Shorten overall time to approval.
  • Spur development of new products to improve companion and food animal medicine.
  • Benefit human health by keeping food animals healthy and food safe!
ADUFA Public Meeting Slide 4

Slide 5

ADUFA patterned after PDUFA

  • PDUFA was in its third cycle and by all accounts was working well for human health products.
  • ADUFA like PDUFA is not a fee for service but rather a supplementary source of funding.
  • ADUFA does not guarantee or assure an approval.
  • No decrease in safety, efficacy, quality, or labeling requirements.
ADUFA Public Meeting Slide 5

Slide 6

What ADUFA Accomplishes

  • Assures a predictable, timely, science-based review process.
  • Provides additional resources for new drug reviews in exchange for meeting review time performance standards.
  • Assures CVM a consistent level of appropriated base funds as a prerequisite to collect user fees.
  • Allows for more reliable development planning for new and innovative animal medicines
ADUFA Public Meeting Slide 6

Slide 7

ADUFA I Assessment

What is your assessment of the overall performance of the ADUFA program thus far?

ADUFA Public Meeting Slide 7

Slide 8

ADUFA I Assessment

AHI concurs that CVM is meeting or exceeding performance goals.

  • Elimination of longstanding backlog.
  • Increased predictability – knowing when a review will be completed.

Six sentinel submissions have been an accurate predictor of overall workload and staffing needs.

ADUFA Public Meeting Slide 8

Slide 9

ADUFA I Assessment

Communications between AHI and CVM significantly improved.

  • CVM and AHI have identified issues ADUFA did not address.
  • CVM more engaged in the issue resolution process.

Too early to know if overall time to approval has shortened.

  • Over last 15 years approval times have increased on average by 3.5 years and costs by 106%.
ADUFA Public Meeting Slide 9

Slide 10

ADUFA Reauthorization

What suggestions or changes would you make relative to the reauthorization of ADUFA?

ADUFA Public Meeting Slide 10

Slide 11

Room for Improvement

Maintain predictability of review times.

  • Continue 90% or better on time performance.
  • There may be a need to identify additional sentinel submission performance standards.

Decrease the number of review cycles to shorten time to approval

  • Issuance of needed guidance documents.
  • Improve quality of submissions.
  • Reduce frequency of incomplete letters.
  • Improve timeliness of foreign inspections.
ADUFA Public Meeting Slide 11

Slide 12

AHI Supports ADUFA

  • AHI is looking forward to working with the Agency on negotiating a new round of agreements.
  • AHI believes ADUFA benefits not only the animal health industry, but also veterinarians, pet owners, and animal producers.
ADUFA Public Meeting Slide 12