ADUFA and AGDUFA: What are they?
Generic User Fee Act Good for Animal Owners
On August 14, 2008, President Bush signed legislation reauthorizing the Animal Drug user Fee Act (ADUFA), which allows for the charging of user fees to approve new drugs, and authorizing the Animal Generic Drug User Fee Act (AGDUFA), which will allow user fees for the review of generic drugs. This legislation provides for more funds and resources to make the review process for generic animal medications more efficient. User fees are to be paid by drug sponsors during the FDA application process.
How are ADUFA and AGDUFA different?
ADUFA was first enacted in 2003 to ensure the safety and effectiveness of new animal drugs. The funding allows for thorough and efficient testing of each new animal drug. AGDUFA is an off-shoot of this, specifically for generic animal drugs that are more affordable than the name brands.
“The AGDUFA is the first ever generic drug user fee program,” said Laura Alvey, Deputy Director of the communications staff at the Center for Veterinary Medicine. “The program will provide consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs. The proposed user fees will enable enhanced, predictable, and sustainable performance-driven programs that maintain high standards for product safety and efficacy. Both AGDUFA and ADUFA will facilitate more efficient development of safe and effective products available for veterinarians and animal producers, thereby improving public health.”
The Importance of Generic Animal Drugs
Before the creation of AGDUFA, animal owners had access to very few generic medications, and since there is no health insurance for animals, name brand drugs can be very expensive. Not very many companies went through the process of getting generic animal drugs approved, and there were not enough resources to review them. In fact, generic animal drugs took about four times longer to get approved than new medications, according to the Generic Animal Drug Alliance (GADA), which is an independent organization that represents the interests of generic animal medication companies before Federal regulatory agencies and Congress.
According to GADA, the more efficient review process provided for through AGDUFA will save money for owners of horses and other animals by encouraging more generic drugs to enter the market, more quickly than before the legislation was enacted. While it may take some time for animal owners to feel the effects of these changes in their pocketbooks, they can look forward to more affordable medications for their pets and livestock in the future.
Thanks to AGDUFA, animal owners may soon experience great savings in generic animal medications.
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