ADUFA: What it Means for the Small Company
- New Companies that have No Existing Marketed Drug Products
- Established Companies that have Existing Products but NO New Drug Development
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.
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).
- 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%.)
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?
- 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.
- 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.
FDA Should Not Support A Continuation of