Institute of Medicine

Board on Health Sciences Policy

Forum on Medical and Public Health Preparedness for Catastrophic Events

Forum on Drug Discovery, Development, and Translation

Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

Workshop Summary

Advancing Regulatory Science for Medical Countermeasure Development

During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)--a partnership among federal, state, and local governments; industry; and academia--is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.

Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary

The Public Health Emergency Medical Countermeasures Enterprise

National Academies of Sciences, Engineering, and Medicine

Board on Global Health

Forum on Microbial Threats

Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since these diseases also know no boundaries and will easily cross borders. Sustaining public and private investment in the development of medical countermeasures (MCMs) before an emerging infectious disease becomes a public health emergency in the United States has been extremely challenging. Interest and momentum peak during a crisis and wane between events, and there is little interest in disease threats outside the United States until they impact people stateside. On March 26 and 27, 2015, the Institute of Medicine convened a workshop in Washington, DC to discuss how to achieve rapid and nimble MCM capability for new and emerging threats. Public- and private-sector stakeholders examined recent efforts to prepare for and respond to outbreaks of Ebola Virus Disease, pandemic influenza, and coronaviruses from policy, budget, and operational standpoints. Participants discussed the need for rapid access to MCM to ensure national security and considered strategies and business models that could enhance stakeholder interest and investment in sustainable response capabilities. This report summarizes the presentations and discussions from this workshop.

Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary

Rapid Medical Countermeasure Response to Infectious Diseases

Preparedness, Response and Recovery Considerations for Children and Families is the summary of a workshop convened in June, 2013 by the Institute of Medicine Forum on Medical and Public Health Preparedness for Catastrophic Events to discuss disaster preparedness, response, and resilience relative to the needs of children and families, including children with special health care needs. Traditional and non-traditional medical and public health stakeholders from across federal, state, and local government health care coalitions, community organizations, school districts, child care providers, hospitals, private health care providers, insurers, academia, and other partners in municipal planning met to review existing tools and frameworks that can be modified to include children's needs; identify child-serving partners and organizations that can be leveraged in planning to improve outcomes for children; highlight best practices in resilience and recovery strategies for children; and raise awareness of the need to integrate children's considerations throughout local and state emergency plans. Communities across the United States face the threat of emergencies and disasters almost every day, natural and man-made, urban and rural, large and small. Although children represent nearly 25 percent of the U.S. population, current state and local disaster preparedness plans often do not include specific considerations for children and families. The preparedness and resilience of communities related to children will require a systems framework for disaster preparedness across traditional and non-traditional medical and public health stakeholders, including community organizations, schools, and other partners in municipal planning. This report examines resilience strategies that lead to successful recovery in children after a disaster and discusses current approaches and interventions to improve recovery in children.

Preparedness, Response, and Recovery Considerations for Children and Families

Our nation faces the distinct possibility of a catastrophic terrorist attack using an improvised nuclear device (IND), according to international and U.S. intelligence. Detonation of an IND in a major U.S. city would result in tens of thousands to hundreds of thousands of victims and would overwhelm public health, emergency response, and health care systems, not to mention creating unprecedented social and economic challenges. While preparing for an IND may seem futile at first glance, thousands of lives can be saved by informed planning and decision making prior to and following an attack. In 2009, the Institute of Medicine published the proceedings of a workshop assessing the health and medical preparedness for responding to an IND detonation. Since that time, multiple federal and other publications have added layers of detail to this conceptual framework, resulting in a significant body of literature and guidance. However, there has been only limited planning effort at the local level as much of the federal guidance has not been translated into action for states, cities and counties. According to an informal survey of community preparedness by the National Association of City and County Health Officials (NACCHO), planning for a radiation incident ranked lowest in priority among other hazards by 2,800 local health departments. The focus of Nationwide Response Issues After an Improvised Nuclear Device Attack: Medical and Public Health Considerations for Neighboring Jurisdictions: Workshop Summary is on key response requirements faced by public health and health care systems in response to an IND detonation, especially those planning needs of outlying state and local jurisdictions from the detonation site. The specific meeting objectives were as follows: - Understand the differences between types of radiation incidents and implications of an IND attack on outlying communities. -Highlight current planning efforts at the federal, state, and local level as well as challenges to the implementation of operational plans. -Examine gaps in planning efforts and possible challenges and solutions. -Identify considerations for public health reception centers: how public health and health care interface with functions and staffing and how radiological assessments and triage be handled. -Discuss the possibilities and benefits of integration of disaster transport systems. -Explore roles of regional health care coalitions in coordination of health care response.

Forum on Medical and Public Health Preparedness for Catastrophic Events

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