Animal drug user fee act
In June the US Senate unanimously passed a bill to amend the Federal Food, Drug, and Cosmetic Act to establish a four-part fee schedule for processing new animal drug applications (NADAs) by the Food and Drug Administration (FDA; Rockville, MD, USA). All genetically modified (GM) animals that could inadvertently enter the food supply as meat or other products, such as GM salmon or milk from GM cows, are considered 'animal drugs' and are regulated by the FDA as such—whether they produce drugs or not. The bill, the Animal Drug User Fee Act of 2003, which is expected to pass the House of Representatives and be signed into law by the end of 2003, would enable the FDA to collect up to $10 million annually, which animal drug producers hope will speed the approval process. The FDA encourages anyone working with such animals to file an investigational new animal drug application (INAD) in order to track these animals and ensure none enter the food supply (Nat. Biotechnol. 21, 720–721, 2003). So far, about 30 such applications have been filed and will be subject to a sponsor's fee should the legislation be enacted. KP
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