A Prescription for Scandal

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As the FDA pursued its own probe, it discovered that Vitarine Pharmaceuticals of New York City had taken a more drastic step to ensure approval of its generic version of Dyazide, a standard antihypertension drug developed by SmithKline. The generic-drug company substituted Dyazide for its own capsules and sailed right through the efficacy tests. Vitarine admitted the deception earlier this month and has recalled the product.

Even if the misdeeds are limited to a few unscrupulous firms and some greedy bureaucrats, the entire generic-drug industry is likely to suffer. Generic products are so anonymous, says Dee Fensterer, president of the Generic Pharmaceutical Industry Association, that "when one company has a problem with one drug, it is jumped on as a problem of all generic drugs."

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CREDIT: [TMFONT 1 d #666666 d {Source: Arthur D. Little, Inc.}]CAPTION: Generic-drug sales

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CREDIT: [TMFONT 1 d #666666 d {Source: FDA}]CAPTION: FDA Inspections