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

doi:10.1056/NEJMp0906490

Volume 361:1230-1233		September 24, 2009		Number 13

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

Randall S. Stafford, M.D., Ph.D., Todd H. Wagner, Ph.D., and Philip W. Lavori, Ph.D.

Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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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. marketfor drugs and devices is regulated by the Food and Drug Administration(FDA), which scrutinizes clinical trial data for evidence ofsafety and efficacy. Although the FDA has been criticized formissteps and inefficiencies in its approval process, these arenot the causes of increasing health care expenditures. Morerelevant is FDA oversight of the labeling and promotion of medicalproducts.

Despite the potential usefulness of labeling information for. . . [Full Text of this Article]

Source Information

From the Stanford Prevention Research Center, Stanford University, Palo Alto (R.S.S.); the Veterans Affairs Palo Alto Health Care System, Palo Alto (T.H.W.); and the Department of Health Research and Policy, Stanford University School of Medicine, Stanford (T.H.W., P.W.L.) — all in California.

This article (10.1056/NEJMp0906490) was published on August 12, 2009, at NEJM.org.