Word: fda
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Dates: during 1980-1989
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...FDA blows the whistle on abuses in new-drug...
Every year scores of new drugs are launched on the American market. Most of them are variations on an existing medicine; the greatest distinction of the newcomer usually is a catchier name. Of the 96 drugs approved last year, only three were judged by the FDA to represent important therapeutic gains. As a result, to push their sometimes unneeded new products, drug companies pour their energy and money into advertising and promotion. Last year $215 million worth of advertisements were placed in the 150 leading medical journals, and that represents only the smallest part of the typical drug promotion campaign...
...number of new-drug approvals has been rising. So much so, says Lloyd Millstein, acting director of the FDA's drug advertising and labeling division, that there has been "a general increase in the level of advertising and competition in the marketplace." The overheated atmosphere has led to marketing tactics that the FDA finds worrisome. Among them: the advertisement of drugs before they are approved, the promotion of prescription drugs not only to doctors but also to consumers, the increasing use of comparative ads in which the deficiencies of competing brands are cited, and a growing tendency to make...
...million patients who have taken it, Lilly maintains, and is "safe and effective when used as directed." In an earlier statement, Lilly took "vigorous exception to any implication that it has withheld data, maintained inadequate records or failed to comply with the scientific requirements of the FDA...
...that given its benefits, the risks are as acceptable as those for other drugs in its class, including, significantly, aspirin. On the other hand, it may find that deliberate or inadvertent failure by Lilly to provide necessary but damaging information about Oraflex, coupled with a sloppy performance by the FDA, allowed on the market a drug whose risks were too high...