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May 12, 1999

The Safety of New Medicines: The Importance of Asking the Right Questions

Author Affiliations

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

JAMA. 1999;281(18):1753-1754. doi:10.1001/jama.281.18.1753

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 be used to prevent, or more realistically, minimize the risk of future unnecessary exposure of patients to adverse drug events. Information on the 5 drugs withdrawn given in Table 7 of the article by Friedman et al1 suggests that such a discussion would be productive.

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