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Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model
countermeasure available to detect, prevent, or treat the disease or injury may be unapproved or approved for different indications. The restricted time frame of a response is unlikely to allow sufficient time to receive FDA approval.
Because of the scope of these programs and the tremendous challenges involved in implementing and executing them, the delivery of medical countermeasures during a public health emergency has been identified as one of the major challenges facing the medical and public health community.
In November 2009, the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events convened a meeting to discuss recent progress made in the nation’s ability to rapidly and effectively deploy medical countermeasures in response to public health threats, along with remaining challenges and vulnerabilities, and strategies to address these challenges in future work.
About the Preparedness Forum
The IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events was established to foster dialogue among a broad range of stakeholders—practitioners, policy makers, community members, academics, and others—and provide ongoing opportunities to confront issues of mutual interest and concern. The Preparedness Forum provides a neutral venue for broad-ranging policy discussions that aid in the coordination and cooperation of public and private stakeholders in developing and enhancing the nation’s medical and public health preparedness. Members include representatives and leaders from local, state, and federal governments; leaders of health professional and business associations; and other stakeholders and key decision makers.
The Preparedness Forum has a long-standing interest in medical countermeasures and has hosted several other workshops on this issue. The first workshop focused largely on opportunities to improve dispensing strategies, especially through public–private partnerships, and associated liability protections for corporations and nonprofit partners (IOM, 2008). A more recent workshop, held in February 2010, examined the Public Health Emergency Medical Countermeasures Enterprise and aimed to identify innovative strategies to enhance products from discovery through approval (IOM, 2010a). Finally, in the spring of 2010 the Forum hosted a series of three regional workshops to examine successes