In concluding, Dr. McClellan emphasized the following points:

  • The FDA needs additional resources and technical capabilities to achieve the goals of the IOM recommendations. While additional regulatory authority, organizational change, and better information are necessary, they are not sufficient and will in fact require yet more resources, including personnel and expertise.

  • A great deal is already being spent on safety in the health care system, and still more will be spent with the reauthorization of PDUFA and the passage of pending drug safety legislation. Additionally, health plans are investing considerably in systems for identifying how drugs are being used and with what consequences.

  • Taking a more collaborative approach to addressing safety issues through public–private partnerships particularly in the conduct of postmarket surveillance would be much more cost-effective than the current piecemeal approach.

  • There are a number of other opportunities for such public–private collaboration to achieve consensus on how to move forward. These include improving safety science; developing better postmarket evidence on the risks and the actual use of drugs; developing more individualized and effective benefit–risk communications; assessing the development and use of new regulatory tools; and ultimately, continuing to improve the regulatory system while avoiding unnecessary costs and delays in access, creating a health care system that delivers the best possible treatment to each patient.

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