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Drug User Fee Law Critical, says NPPC

by 5m Editor
28 April 2008, at 10:22am

US - The National Pork Producers Council has urged Congress to reauthorize the Animal Drug User Fee Act (ADUFA), after the US Food and Drug Administration sent recommendations for the law to Capitol Hill.


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"It's a critical tool needed by the pork industry and veterinarians to maintain animal health and to provide safe, wholesome and nutritious pork"
Bryan Black, NPPC President.

Enacted in 2003, ADUFA authorizes FDA to collect fees from the animal health industry to be used for the review and approval of animal health products. The fees supplement the agency’s annual congressionally-approved appropriations and have enabled 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 effectiveness.

“ADUFA ensures that animal health companies are able to provide in a timely manner products to treat and control the new diseases that our animals will face,” said NPPC President Bryan Black, a pork producer from Canal Winchester, Ohio.

“It's a critical tool needed by the pork industry and veterinarians to maintain animal health and to provide safe, wholesome and nutritious pork,” he said.

Since ADUFA was signed into law, four new swine health products have come on the market, helping producers fight the increasing challenges that swine respiratory diseases have created for the industry. Additionally, last year alone, veterinarians and pet owners received nine new products to help pets live longer, healthier lives.

Recommendations

Among its recommendations, FDA proposed a new user fee program – the Animal Generic Drug User Fee Act (AGDUFA) – to support the review of generic animal drug applications. Currently, FDA’s review of generic animal drugs is entirely funded through appropriations. The agency also recommended an “end review amendment” process, which would allow it to work with a drug manufacturer at the end of a review to make corrections to an application, resulting in reduced review time. FDA also asked that the reauthorized law include an agreement between the agency and industry to participate in 10 workshops over the next five years to improve communications between regulators and industry.

Lawmakers are expected to take up reauthorization of ADUFA, which expires Sept. 30, in the coming weeks. The law is expected to generate $98 million in user fees over the next five years; AGDUFA is estimated to bring in $27 million.

“NPPC will be very aggressive in lobbying Congress for a quick, clean reauthorization of this important law,” said Black. “ADUFA is a top priority for the U.S. pork industry.”

5m Editor