Meeting the challenges of medical countermeasure development.

Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three-pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures - and the systems to deliver them - and the requisite support of all stakeholders, including national leadership.

Public health and medical responses to the 1957-58 influenza pandemic.

As the U.S. prepares to respond this fall and winter to pandemic (H1N1) 2009, a review of the 1957-58 pandemic of Asian influenza (H2N2) could be useful for planning purposes because of the many similarities between the 2 pandemics. Using historical surveillance reports, published literature, and media coverage, this article provides an overview of the epidemiology of and response to the 1957-58 influenza pandemic in the U.S., during which an estimated 25% of the population became infected with the new pandemic virus strain. While it cannot be predicted with absolute certainty how the H1N1 pandemic might play out in the U.S. this fall, lessons from the 1957-58 influenza pandemic provide useful and practical insights for current planning and response efforts.

Healthcare coalitions: the new foundation for national healthcare preparedness and response for catastrophic health emergencies.

After 9/11 and the 2001 anthrax letters, it was evident that our nation's healthcare system was largely underprepared to handle the unique needs and large volumes of people who would seek medical care following catastrophic health events. In response, in 2002 Congress established the Hospital Preparedness Program (HPP) in the U.S. Department of Health and Human Services (HHS) to strengthen the ability of U.S. hospitals to prepare for and respond to bioterrorism and naturally occurring epidemics and disasters. Since 2002, the program has resulted in substantial improvements in individual hospitals' disaster readiness. In 2007, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) contracted with the Center for Biosecurity of the University of Pittsburgh Medical Center to conduct an assessment of U.S. hospital preparedness and to develop tools and recommendations for evaluating and improving future hospital preparedness efforts. One of the most important findings from this work is that healthcare coalitions-collaborative groups of local healthcare institutions and response agencies that work together to prepare for and respond to emergencies-have emerged throughout the U.S. since the HPP began. This article provides an overview of the HPP and the Center's hospital preparedness research for ASPR. Based on that work, the article also defines healthcare coalitions and identifies their structure and core functions, provides examples of more developed coalitions and common challenges faced by coalitions, and proposes that healthcare coalitions should become the foundation of a national strategy for healthcare preparedness and response for catastrophic health events.