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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
released its report—The Future of Drug Safety: Promoting and Protecting theHealth of the Public—which included 25 recommendations for improving the system for drug safety review. The committee 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; 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 recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments. The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. Without substantial increases in agency funding, making the recommended improvements in the agency’s ability to identify safety problems in new drugs, monitor routinely submitted safety data, and relay that information to the public would require the diversion of funds from other mission-critical areas.
To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. The symposium’s presentations and discussions were in most cases framed by selected recommendations from the report, and are summarized here in seven key areas:
addressing the FDA’s resource challenges;
strengthening the scientific base of the agency;
integrating pre- and postmarket review;
enhancing postmarket safety monitoring;
conducting confirmatory drug safety and efficacy studies;
enhancing the value of clinical trial registration; and
enhancing the FDA’s postmarket regulation and enforcement.
The presentations and discussions included the types and magnitude of resources required in these areas. A session at the close of the symposium looked to the future, exploring prerequisites for revitalizing the U.S. drug safety system and the future of drug safety regulation. It should be noted that, while the IOM report suggested some organizational and cultural changes at the FDA, those recommendations were not a focus of the dis-