New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling

The FDA does not currently require label statements regarding a product's comparative effectiveness. Dr. Randall Stafford, Todd Wagner, and Philip Lavori propose an expanded labeling requirement that would provide explicit information about proven comparative benefits or lack thereof. New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000. 1 The U.S. market for drugs and devices is regulated by the Food and Drug Administration (FDA), which scrutinizes clinical trial data for evidence of safety and efficacy. Although the FDA has been criticized for missteps and inefficiencies in its approval process, these are not the causes of increasing health care expenditures. More relevant is FDA oversight of the labeling and promotion of medical products. Despite the potential usefulness of labeling information for . . .