Diabetes Drugs Face Tougher Rules

FDA Is Weighing Mandated Benefit To Heart, Life Span By JARED A. FAVOLE and ALICIA MUNDY Wall Street Journal June 28, 2008; Page B7 WASHINGTON -- The Food and Drug Administration is considering tougher standards for new and current diabetes drugs, raising concern in the pharmaceutical industry that the agency may ultimately raise the time and cost needed to approve of a wide array of new drugs. The FDA is weighing whether to insist that new diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar.