Differences in Manufacturer Reporting of Adverse Drug Reactions to the FDA in 1984

Abstract

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