Evaluation of First Year Experience of a State Pilot Project to Promote Physician Reporting of Adverse Drug Events to the Food and Drug Administration

The US Food and Drug Administration (FDA) has maintained a spontaneous, voluntary system for the reporting of adverse drug events for over three decades. Based on the experience of the American Medical Association registry for drug-related aplastic anemia, the FDA spontaneous reporting system (FDA-SRS) was initiated following the public reaction to thalidomide-induced phocomelia. The chief criticism of the SRS has been in the unrepresentativeness of its data: the SRS is voluntary, and reporting rates vary among physician groups, among drug classes, and according to the age of the drug. To increase the likelihood of surveying community physicians, areas of Rockville and Bethesda, where large government research facilities are located, were excluded. Fifty-seven percent of the responders knew about SRS. Maryland physicians believed reporting to be a professional obligation and expressed little concern about governmental interference, time consumption, or the need for an easier method.