Word: fda
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
...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...
...heart medication marketed by Pfizer Inc. under the brand name Procardia. Introduced with a splashy campaign after approval in January, the drug racked up $17 million in sales in twelve weeks, vastly outselling verapamil, a similar product marketed by the Searle and Knoll pharmaceutical companies. Late last month the FDA blew the whistle. In a ten-page letter issued to Pfizer, the agency complained that the Procardia campaign was "false and misleading in its overall message," and that by misrepresenting important warnings, it "increases the risk of serious adverse reactions to patients." Procardia is a valuable treatment for chest pain...
...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...