The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.
If adopted by Congress, the Animal Drug User Fee Act (ADUFA) reauthorization would provide funding for the review of new animal drug applications for the next five years. In addition, the first generic user fee program (the Animal Generic Drug User Fee Act or AGDUFA) would support the review of generic animal drug applications and maintain current standards of safety and effectiveness. The funding is tied to meeting specific performance goals that will ensure efficient scientific evaluation of the safety and effectiveness of animal drugs.
"We are pleased to provide our recommendations to Congress today, as they are important components of our desire to provide the best products possible for animal care," said Bernadette Dunham, D.V.M., Ph.D., director of the FDA's Center for Veterinary Medicine.
The ADUFA recommendations include an "end review amendment" process which will enable the FDA to work with a drug manufacturer at the end of a review to make corrections to an application, resulting in reduced review time. In addition, the proposal will help fund an information technology initiative that will advance the review process towards an electronic environment, substantially cutting down on the use of paper and the need for storing paper documents. The recommendations include an agreement by the agency and industry to participate in 10 public workshops over the next five years in order to improve communications between regulators and industry. The reauthorization also allows for the increase of current user fees in line with inflation.
First authorized in 2003, ADUFA created a framework by which drug manufacturers pay fees that supplement the agency's appropriations and animal drug reviewers meet demanding performance deadlines. The ADUFA program, which must be reauthorized by Congress every five years, has enabled the FDA to dramatically reduce its review time of new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and efficacy. In fiscal year 2004, FDA reviewed 90 percent of all new animal drug applications within 295 days. In fiscal year 2008, FDA reduced review time for 90 percent of new animal drug applications to 180 days.
If reauthorized, ADUFA is expected to generate $98 million in user fees over the next five years to support FDA review of these new animal drug applications.
AGDUFA would provide for drug manufacturers to pay fees that supplement the Agency's appropriations to speed review of generic animal drug applications. AGDUFA would place timeframes on the review of generic animal drug applications, similar to the process already implemented in the review of novel animal drugs applications. The proposed legislation will generate an estimated $27 million in user fees over five years.
Currently, the FDA's review of generic animal drugs is entirely funded through appropriations.
For more information, visit http://www.fda.gov/oc/opacom/hottopics/adufa_agdufa/adufareauth.html.