LEGISLATIVE PHARMACOECONOMIC STANDARD NEED NOT PRECLUDE RIGOROUS STUDIES -- FDA's TEMPLE; DATA BASE ANALYSES ARE NOT SUITABLE FOR COST-EFFECTIVENESS CLAIMS
Executive Summary
The attempt by Congress to set a new legislative standard for FDA oversight of pharmacoeconomic claims should not discourage companies from performing rigorous analyses of their products, Center for Drug Evaluation & Research Associate Director for Medical Policy Robert Temple, MD, told a meeting of the Food & Drug Law Institute Sept. 4 in Washington, D.C.