On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA).
ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extend ADUFA until 2013. ADUFA amends the Food, Drug and Cosmetic Act to authorize FDA to collect fees to enhance the performance of the new animal drug review process and ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.
President Bush also signed into law the Animal Generic Drug User Fee Act (AGDUFA) of 2008. This Act amends the Food, Drug and Cosmetic Act by requiring generic animal drug companies to pay user fees for the first time. These fees will enable FDA to better ensure that generic new animal drug products are safe and effective and give consumers a lower cost alternative to pioneer drugs.
The Animal Drug User Fee Amendments of 2008 is available online.
[Ed. Note: ADUFA was first authorized in 2003 and required drug manufacturers to pay a fee to FDA to support new animal drug reviews. FDA used these fees to hire additional review staff which enabled the agency to shorten the drug approval process. By most accounts, the program has been successful and is being expanded to include generic drug manufacturers. A similar program exists for human drugs as well. The reauthorization was supported by veterinary associations (including AASV & AVMA), producer groups (including NPB & NPPC) and the pharmaceutical companies.]
Source:
FDA, CVM Press Release