Dick Lugar: “I am pleased that the Animal Drug Availability Act (S. 773) is before the full Senate for consideration today. As an…”

“I am pleased that the Animal Drug Availability Act (S. 773) is before the full Senate for consideration today. As an original cosponsor of this legislation, I recognize the need for reform of the Food and Drug Administration [FDA] animal drug approval process. Producers and manufactures of animal drugs have been concerned with the lengthy time required to gain FDA approval of animal drugs as well as the lack of new drug options available to treat livestock and poultry. The legislation before us today is a consensus bill that is acceptable to FDA, agricultural procedures, pharmaceutical and animal health organizations and has garnered bipartisan support in the Senate. I had written to Senator Kassebaum recently urging prompt action on this legislation and thank her for her efforts to move this bill forward. The bill before us today will provide FDA with greater flexibility to determine when animal drugs are effective for intended uses; streamline approval of combination animal drugs when the drugs have been previously approved separately for the same species and conditions of use; provide FDA with greater flexibility in whether field investigations are necessary to prove efficacy; and require presubmission conferences to help FDA and drug manufacturers to reach agreement on testing requirements before a drug application is submitted to FDA.”