Healthy Skepticism Library item: 9589

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Publication type: Journal Article

Baum C, Faich GA, Anello C, Forbes MB.
Differences in manufacturer reporting of adverse drug reactions to the FDA in 1984
Drug Information Journal 1987; 21:(3):257-266

Abstract:

Pharmaceutical firms were ranked by the number of adverse drug reaction reports that the FDA received from them in 1984. Twenty companies submitted 79% of all reports. These companies were assessed in terms of their total prescriptions, hospital and drug store sales, and detailing calls. All 3 variables were correlated with the number of reports, but dollar sales were the best predictor of report volume. Reports from the top 20 firms were no more likely to have serious outcomes than those from the other firms, but they were more likely to have unknown outcomes. The top 20 firms submitted new chemical entity reports at a rate almost twice that of other companies, and their nonsteroidal anti-inflammatory drug reporting rate was 8 times as great. These companies submitted 85% of the total new chemical entity reports, while only 73% of the new chemical entity reports sent directly to the FDA were for products manufacturered by these companies.