"Statement of Janet Heinrich, Associate Director Health Financing and Public Health Issues"
Testimony before the "Subcommittees on Health and Environment, and Oversight and Investigations, Committee on Commerce, and Subcommittee on Health, Committee on Veterans’ Affairs, House of Representatives"
"In our recent review of the research on adverse drug events, we learned what is known about the strengths and limitations of adverse event reporting systems of both the mandatory and voluntary variety. It is well known that all spontaneous reporting systems experience a high level of underreporting. For example, FDA believes that its system for gathering information about ADEs, the Adverse Event Reporting System (AERS), receives reports for only about 1 to 10 percent of all ADEs. Indeed, FDA relies on AERS primarily to generate 'signals' of new adverse drug events that the agency can then investigate through other data sources."