FDA Can Further Improve Its Adverse Drug Reaction Reporting System

GAO reviewed the Food and Drug Administration's (FDA) adverse drug reaction reporting system, because a comprehensive survey of FDA monitoring of prescription drugs showed that many of the problems identified in a previous report still exist. In that report, GAO noted that the reporting system was underused as a tool to regulate marketed drugs.

GAO found that medical officers are making more use of the reporting system than they previously did. Many said that the system is useful and is improving. The Division of Drug Experience has offered seminars and workshops on the capabilities and limitations of the reporting system. Despite this training, some medical officers indicated that they were unaware of what the system could do. GAO reviewed individual drug reaction reports submitted by the manufacturers and found that less than half had been entered into the system and only 60 percent had reached the Division. As a result, the system failed to identify some potentially serious adverse reactions. FDA needs all the information available if it is to make timely determinations on the need for regulatory action. The procedures for routing adverse reaction reports submitted by manufacturers were revised to allow reports to reach the Division sooner. This change, however, may not result in more reports getting into the system. Because of the current budget situation, additional staff and resources may not become available, and FDA should explore alternative methods of evaluating and entering reports into the system. The Division entered over 115,000 reports into the adverse reporting system. The largest number of reports were received from manufacturers. Little has been done to encourage reporting from sources other than manufacturers, but the Division plans to increase nonmanufacturer reporting. GAO explored alternatives of increasing adverse reaction reporting.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Franklin A. Curtis Team: General Accounting Office: Human Resources Division Phone: (202) 275-5451