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Congress Approves Animal-Drug Review Laws

by 5m Editor
5 August 2008, at 10:16am

WASHINGTON, D.C. - The National Pork Producers Council today praised Congress for approving legislation to reauthorize an animal-drug review law and to implement a new generic animal-drug review statute, both of which will give pork producers access to products that safeguard animal and public health.

The Senate today approved H.R. 6432, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), by unanimous consent. The House July 30 passed the bill on a voice vote.

“We want to commend the leadership on both sides of the aisle in the Senate and House for approving this important legislation,“ said NPPC President Bryan Black, a pork producer from Canal Winchester, Ohio. “Congress’ action will help ensure that pork producers have access to products that keep our pigs healthy and our products safe and wholesome.“

First enacted in 2003, ADUFA allows the U.S. Food and Drug Administration to collect fees from the animal health industry 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 for new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and effectiveness. AGDUFA will do the same for generic animal drugs.

The laws will require animal health companies to report to FDA by March 31 of each year certain data related to the distribution and export of animal health products. (Although individual company data will be kept confidential, FDA will publish an aggregate of it.) Some lawmakers had proposed that the drug firms and livestock producers publicly report such data as well as information on uses of animal health products.

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.

“Pork producers have always supported science-based efforts to protect public health,“ said NPPC’s Black. “Today’s bill included enhanced animal-health company reporting requirements to further promote public health. These additional requirements do not limit producer access to important animal health products.“

5m Editor