Slide 1 ADUFA Public Meeting Animal Health Institute
April 24, 2007
Richard Carnevale, VMD
VP, Regulatory, Scientific and International Affairs |  |
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.
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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.
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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!
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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.
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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
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Slide 7 ADUFA I Assessment What is your assessment of the overall performance of the ADUFA program thus far? |  |
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. |  |
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%.
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Slide 10 ADUFA Reauthorization What suggestions or changes would you make relative to the reauthorization of ADUFA? |  |
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.
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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.
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