Animal & Veterinary
AGDUFA to Bolster Generic Drug Review at CVM
FDA Veterinarian Newsletter 2008 Volume XXIII, No V
On August 14, 2008, President Bush signed into law the Animal Generic Drug User Fee Act of 2008 (AGDUFA), the first user-fee program (animal or human) for generic drugs.
Under AGDUFA, the generic animal drug industry pays user fees that will provide essential resources to improve generic animal drug review times for the purpose of meeting established performance goals. This improvement allows companies to bring their approved generic animal drug products to the consumer in a greatly reduced time frame. These user fees will supplement resources appropriated by Congress for generic animal drug review.
FDA also has in place a user fee program for pioneer animal drugs. This program has been widely considered a success. In fact, AGDUFA was sent to Congress along with the proposal to reauthorize the user fee program for pioneer drugs—the Animal Drug User Fee Act (ADUFA). Congress also approved the re-authorization of the user fee program under ADUFA II.
It is anticipated that AGDUFA will generate an estimated $27 million in user fees over the next 5 years with FDA collecting $4.8 million in fiscal year 2009. (AGDUFA will be in effect during Fiscal Years 2009 – 2013.)
FDA has established time frames for reviewing original ANADAs, manufacturing supplemental ANADAs, administrative ANADAs, generic investigational new animal drug data submissions and protocols. The review time frames for these types of submissions will shorten over the next 5 years.
Over the years, Dr. Harshman has seen CVM’s Generic Animal Drugs Team increase its level of performance. To the team’s credit, this increase in number of approvals (especially in the past 5 years) has occurred in the face of a mounting workload. With the implementation of AGDUFA, the increase in resources will erase the backlog of applications and reduce the time to approval for a wide variety of generic products.