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Commentary |

The Report by the Institute of Medicine and Postmarketing Surveillance

Donald F. Klein, MD
Arch Gen Psychiatry. 1999;56(4):353-354. doi:10.1001/archpsyc.56.4.353.
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THE REPORT by the Institute of Medicine (IOM)1 was developed from an IOM study requested and funded by the US Food and Drug Administration (FDA). It was prompted by the controversy over the approval process for triazolam (Halcion; Upjohn Co, Kalamazoo, Mich). Although an FDA task force already considered the drug safe and effective when used according to the labeling, an independent panel was considered necessary.

The charge to the IOM goes beyond the usual concerns of the FDA about the adequacy of the pivotal clinical trials in a request for drug approval. The FDA further wishes the IOM to comment on the quality and quantity of postmarketing data, confidence in data on the effectiveness and adverse effects of Halcion at different doses and for different durations, and the need for additional studies.

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