Word: generics
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Compared with an original, patented drug, a generic is much less expensive to develop. After the patent on a brand-name product has expired, usually involving a period of 17 years, a pharmaceutical company simply replicates the original drug's components. But in a two-year study released earlier this month, the American Academy of Family Physicians found that many generics are not as potent as their originals. Reason: unless certain production tricks are used, it is often difficult to produce a formulation that will work as well in the body as the brand-name drug. In its approval process...
...firm consistently won FDA approval for its products before his company did, McKnight hired private detectives to spy on the Government. The detectives' snooping produced enough evidence of corruption to encourage the Justice Department to initiate a probe. In July, Charles Chang, 47, former head of the FDA's generic-drug division, and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment. The favored firms: American Therapeutic Inc., Bohemia, N.Y.; Par Pharmaceutical, Spring Valley, N.Y.; and Par's subsidiary Quad Pharmaceuticals of Indianapolis. American Therapeutic has not been charged...
...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...
CREDIT: [TMFONT 1 d #666666 d {Source: Arthur D. Little, Inc.}]CAPTION: Generic-drug sales...