Drug & Device News

A report issued in December by the Government Accountability Office (GAO), faults the U.S. Food and Drug Administration's (FDA's) management of postmarket drug safety information. The FDA is supposed to keep track of postmarket studies and other data concerning safety problems with FDA-approved medications that have entered the market, but its current systems are apparently inadequate for this purpose. According to the report, “Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER (Center for Druge Evaluation) of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.” Because of these inadequate systems, data is not being recorded and made accessible in a way that would allow the FDA to publish statutorily required reports on potential drug safety issues.