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January 27, 1999

Time for Action on Drug Safety—Reply

Author Affiliations

Margaret A.Winker, MDIndividualAuthorPhil B.FontanarosaMD, Senior EditorsIndividualAuthor

JAMA. 1999;281(4):319-322. doi:10-1001/pubs.JAMA-ISSN-0098-7484-281-4-jbk0127

In Reply: While we agree with Dr Burkhart that drug-induced injuries and deaths are more complex to identify than motor vehicle and airplane crash casualties, extensive scientific literature documents the feasibility of doing so.13 The growing size and sophistication of electronic health data systems also mean that larger studies can be conducted at modest cost. Gathering this information is essential. Developing a rational strategy to reduce the death toll and serious injury from ADRs requires much better estimates about who is harmed by ADRs and why than the estimates now available. With regard to the issue of independence, we continue to believe, as did the FDA's outside consultants, that after initial drug approval, evidence about new serious ADEs is best evaluated by an independent drug safety office with a fresh perspective and no prior view of the hazard.

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