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Animal Drug Review Laws Approved

The Senate has approved H.R. 6432, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) by unanimous consent, the National Pork Producers Council reported Aug. 1. The House passed the bill on a voice vote July 30.

First enacted in 2003, ADUFA allows the Food & 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.

Source: Feedstuffs