FDA Outlines Steps for Improving Safety Reviews, Monitoring
The Food and Drug Administration (FDA) last week released a report outlining steps the agency is taking or plans to take to improve its safety programs.
The changes, said FDA Commissioner Dr. Andrew von Eschenbach, are intended to allow the agency to "keep pace with the rapid evolution of science, technology, and the health care system."
The report includes a series of initiatives that already are under way, as well as new initiatives developed in response to some of the recommendations in a report released last September by the Institute of Medicine (IOM), The Future of Drug Safety: Promoting and Protecting the Health of the Public.
Implementing some of the steps outlined in the report, FDA explained in a statement, will depend on whether the agency receives additional funding from the Prescription Drug User Fee Act, which is up for congressional reauthorization. Under this program, drug and biologic manufacturers pay so-called user fees that are used to help support FDA's review and postmarket safety activities.
Among the changes that have already been initiated is the addition of signal detection and tracking tools to FDA's Adverse Event Reporting System database, or AERS. The new tools, FDA said, will allow staff who review AERS reports to more efficiently and effectively identify and track safety signals.