Getting The Lead Out At The Fda

The event was a study in how much a hidebound federal agency can change. A clinical trial published in September, 1992, proved that Vasotec, a Merck & Co. drug that treats severe heart problems, also helps victims of milder heart ailments. To be approved for the new use, the drug normally would have endured a lengthy review at the Food & Drug Administration. But this time, the FDA moved swiftly. Before Merck could file an application, FDA reviewers got test data from the National Institutes of Health, started the regulatory process, and in six months were ready to grant approval. "We've never done that before," says Dr. Robert J. Temple, a top official at the FDA's Center for Drug Evaluation & Research.

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