sensus report with recommendations for the system’s improvement—The Future of Drug Safety: Promoting and Protecting the Health of the Public (hereafter referred to as the IOM report)—was released on September 22, 2006. The IOM committee that produced the report identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing (an underlying issue being the use of modern information technology and informatics, and the human expertise and systems that enable their use); and (4) unclear regulatory authority and insufficiently flexible regulatory tools (IOM, 2007a).

Since the IOM report was issued, the FDA has taken a number of steps toward implementing the improvements recommended by the report (see Box 1-1). Like many government agencies, however, the FDA is financially

BOX 1-1

Highlights of the FDA’s Response to the IOM Report

Strengthening the Science


Improving how the agency assesses risk is a central component of the FDA’s efforts to improve pharmaceutical drug safety. The agency is operating in this area with the belief that new scientific discoveries and the expanded availability of new data sources for pharmacoepidemiological research are creating an emerging science of safety that will support a life-cycle approach to drug safety (e.g., by helping to build safety into products prior to approval and by targeting patients who are more likely to benefit from a given product). The FDA has already started or is taking steps toward initiating a pilot program to review systematically new safety data for new molecular entities (NMEs) approximately 18 months after approval; upgrading the electronic Adverse Event Reporting System* (AERS) and expanding safety database resources in an effort to strengthen epidemiological surveillance methods and tools; and employing several Critical Path Initiative** activities designed to improve safety evaluation and establish best practices for protocol reviews.


Improving Communication and Information Flow


Improving the FDA’s communication and information flow is another key component of the agency’s current efforts to strengthen the effectiveness of the U.S. drug safety system. The FDA believes that open and transparent communication among the agency, health care providers, and patients is paramount to the rapid and



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