Advancing Regulatory Science For Medical Countermeasure Development

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.

This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.

The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions' resources. The Centers for Disease Control and Prevention's (CDC's) Strategic National Stockpile (SNS) is the nation's repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response's (OPHPR's) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation's health. The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC's SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop.

The fascinating story of Tamiflu's development and stockpiling against global health threats.orld's most prominent medical countermeasure, Tamiflu. A pill can strengthen national security? The suggestion may seem odd, but many states around the world believe precisely that. Confronted with pandemics, bioterrorism, and emerging infectious diseases, governments are transforming their security policies to include the proactive development, acquisition, stockpiling, and mass distribution of new pharmaceutical defenses. What happens—politically, economically, and socially—when governments try to protect their populations with pharmaceuticals? How do competing interests among states, pharmaceutical companies, regulators, and scientists play out in the quest to develop new medical countermeasures? And do citizens around the world ultimately stand to gain or lose from this pharmaceuticalization of security policy? Stefan Elbe explores these complex questions in Pandemics, Pills, and Politics, the first in-depth study of the world’s most prominent medical countermeasure, Tamiflu. Taken by millions of people around the planet in the fight against pandemic flu, Tamiflu has provoked suspicions about undue commercial influence in government decision-making about stockpiles. It even found itself at the center of a prolonged political battle over who should have access to the data about the safety and effectiveness of medicines. Pandemics, Pills, and Politics shows that the story of Tamiflu harbors deeper lessons about the vexing political, economic, legal, social, and regulatory tensions that emerge as twenty-first-century security policy takes a pharmaceutical turn. At the heart of this issue, Elbe argues, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in.

The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.