December 15, 2003

 

 President Signs Animal Drug User Fee Act

Posted on December 1, 2003
 
PRESIDENT SIGNS
ANIMAL DRUG USER FEE ACT


On Nov. 18, President Bush signed the Animal Drug User Fee Act, helping to dramatically reduce the review time for new animal drugs.

ADUFA had the support of Food and Drug Administration Commissioner Mark McClellan, who requested that President Bush sign the bill.

Modeled after the successful Prescription Drug User Fee Act, ADUFA gives the FDA the resources and incentives to expedite New Animal Drug Applications.

Despite a statutory review time of 180 days and the enhanced flexibility granted the FDA in the Animal Drug Availability Act, the review process for New Animal Drug Applications typically takes 5 to 10 years.

When he introduced ADUFA in the House of Representatives last March, Michigan Rep. Fred Upton said the review process jeopardizes animal health by delaying the release of new animal drugs necessary for healthy pets, flocks, and herds.

The legislation passed by Congress in November authorizes the collection of annual user fees totaling $43 million over five years, beginning with $5 million in 2004. This enables the FDA to hire and train additional scientific reviewers and implement enhanced processes to accelerate and improve the review of new animal drugs.

Veterinarian and senator John Ensign of Nevada introduced the Senate version of ADUFA earlier this year.

A large coalition supported passage of ADUFA. Led by the AVMA, coalition members include the Animal Health Institute, American Association of Equine Practitioners, American Sheep Industry Association, National Pork Producers Council, and National Turkey Federation.

"The passage of ADUFA is an excellent example of how the AVMA works effectively in coalitions and grass-roots involvement of veterinarians across the country to pass legislation," said Dr. Michael Chaddock, director of the AVMA Governmental Relations Division in Washington, D.C.