Review of the Annual Reporting Process for Investigational New Drugs Regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research

EXECUTIVE SUMMARY:

Sponsors investigating new drugs and testing such drugs on human subjects are required to report annually to the Food and Drug Administration (FDA) summarizing the progress of the investigation during the prior year. Among other things, the report is to include information on the number of subjects who enrolled, dropped out, or died, summaries of adverse experiences, safety reports, significant manufacturing or microbiological changes, and plans for the coming year. Our final audit report points out that the FDA has been lax in enforcing this annual reporting requirement. As of July 1, 1997, outstanding reports totaled 267, some of which were overdue by more than 10 years. As such, the FDA is missing opportunities to obtain access to critical information essential to monitoring patient safety and the opportunity to tabulate valuable summary data necessary to identify patterns and trends. Since our review began the FDA has taken action to reduce the number of overdue reports. Additional improvements are needed, however. The FDA generally concurred with our recommendations regarding actions the FDA can take to significantly improve oversight of this area.

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