Word: fda
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Dates: during 1980-1989
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...alerted to the danger of the suspect drug as soon as the connection was made. Police cruisers, rolling through Chicago streets Thursday afternoon and evening, blared warnings over loudspeakers. All three national television networks carried stories about the contaminated drug on the Thursday-evening news. On Friday, the FDA belatedly advised consumers to "avoid in prudence" all bottles of the capsules. By then it was virtually impossible to obtain Extra-Strength Tylenol anywhere in the Chicago area or indeed in many locations around the country. Two Midwestern retail chains, Jewel and Walgreen, withdrew all bottles of the pain reliever from...
...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...
...correct the abuses, the FDA ordered Pfizer to revise its promotional material, send letters to all physicians who might have received the original literature and publish "remedial advertisements" in two issues of each publication carrying the objectionable ads. Last week Pfizer informed the FDA that it has begun to make those amends. In addition, says company Vice President Dr. Sheldon Gilgore, "we've decided to stay out of comparative advertising...
...Procardia letter is not the only example of an FDA corrective attack on drug-advertising practices. Last June the agency ordered Eli Lilly and Co. to revise the press kit it had prepared on Oraflex, an arthritis medication. The kit contained releases implying that the drug could retard the course of arthritis, a claim based on inconclusive animal studies. Lilly had taken the bold course of promoting its product directly to the consumer, and the misleading claim was trumpeted in newspapers and on television. The result was an enormous demand: more than $6 million in sales for Oraflex...
...FDA hopes so. Agency Commissioner Arthur Hull Hayes has already indicated that he will more closely monitor promotional statements made in press kits and at scientific conferences, especially for the huge heart and arthritis markets, where the rewards for overstatement are most tempting. In addition, the agency has issued guidelines to control the growing practice of advertising drugs before they are approved. Henceforth, such ads may not make any claims about the safety or efficacy of a product, and if a drug is named, the ad cannot detail its uses. Ciba-Geigy met these requirements by not naming the antidepressant...