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Phil B. Fontanarosa, MD; Drummond Rennie, MD; Catherine D. DeAngelis, MD, MPH

JAMA. 2004;292:2647-2650. Published online November 22, 2004 (doi:10.1001/jama.292.21.2647)

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Physicians and patients expect that when medications are prescribed correctly for labeled indications and are used as directed, these medications generally will have beneficial effects and will not cause significant harm. This confidence in pharmaceutical products reflects trust in the effectiveness and integrity of the drug approval and monitoring process.

However, the current approval process for drugs and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from industry. For instance, since adoption of the 1992 Prescription Drug User Fee Act, which augmented the budget of the Food and Drug Administration (FDA) by charging "user fees" to pharmaceutical firms,¹ the FDA has received approximately $825 million in fees from drug and biologic manufacturers from fiscal years 1993 through 2001.^2-3 During that time, median approval times for standard (ie, "nonpriority") . . . [Full Text of this Article]

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