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The Importance of Asking the Right Questions

Alastair J. J. Wood, MD

JAMA. 1999;281:1753-1754.

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

The article in this issue of The Journal by Friedman and colleagues¹ at the US Food and Drug Administration (FDA) explores the important question: "Has the number of drug withdrawals increased since the passage of the Prescription Drug User Fee Act?" This question was stimulated by an apparent spate of recent removals—5 drugs in 1 year. However, when the data were analyzed, not by the year of drug removal but by the year of drug entry into the market, the clustering of cases was not apparent. This finding is reassuring as it does not support previous criticism of the changes that followed the passage of the legislation. The rejection of 1 hypothesis should be viewed as a challenge to the scientific community and the FDA to enter into a public discussion to define what can be learned from the removal of these drugs and can . . . [Full Text of this Article]

Author Affiliation: Division of Clinical Pharmacology, Vanderbilt University, Nashville, Tenn.

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The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?
Michael A. Friedman, Janet Woodcock, Murray M. Lumpkin, Jeffrey E. Shuren, Arthur E. Hass, and Larry J. Thompson
JAMA. 1999;281(18):1728-1734.
ABSTRACT | FULL TEXT