Nancy Kassebaum: “today, together with a bipartisan group of colleagues, I am introducing the Animal Drug Availability Act of 1995. This…”

“today, together with a bipartisan group of colleagues, I am introducing the Animal Drug Availability Act of 1995. This legislation will reform the Food and Drug Administration's animal drug approval and export processes and policies. There is a serious lack of drugs for treating animals, in part because the drug review process at the Food and Drug Administration's Center for Veterinary Medicine is cumbersome and unpredictable. This discourages the development of new drugs. The FDA has approved only four new chemical entities (new drugs) for food-producing animals in the last 5 years. Further, an internal study by the Center for Veterinary Medicine found that the agency was taking an average of 58 months to approve drug applications. By law, the process should take no more than 6 months. The extra-label drug bill that was signed into law last year is a short-term response to this problem. It assures that veterinarians can legally prescribe drugs approved for one use or species for other uses or species. But all involved in the extra-label bill last year agreed that the real answer to the problem was reforming the animal drug approval process.”