Strengthening the US Medical Countermeasure Enterprise for Biological Threats

B iological threats, which range from naturally occurring outbreaks of infectious disease to intentional acts of bioterrorism, pose unique dangers to public health and national security in the United States. Medical countermeasures (MCMs)—drugs, vaccines, diagnostic tests, and other therapies and devices—rank among the most important assets in the nation’s arsenal against dangerous pathogens, as well as chemical, radiological, and nuclear threats. Communities with access to vital MCMs are better equipped to detect both accidental and deliberately caused outbreaks quickly, immunize susceptible populations, and treat infected patients, thereby alleviating the consequences associated with infectious diseases: illness and death, economic losses, societal unrest, and strained public health and healthcare delivery systems. The United States relies on the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to develop, approve, purchase, and distribute the MCMs needed to mitigate biological threats and their impacts on health and security. PHEMCE, which is led by the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), includes several HHS partners, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Other interagency partners include the Department of Defense (DoD), the Department of Veterans Affairs (VA), the Department of Homeland Security (DHS), and the US Department of Agriculture (USDA). Among these entities, NIH (which includes the National Institute of Allergy and Infectious Diseases) is a driving force for early-stage biomedical research on infectious disease prevention and treatment. DoD operates a Medical Countermeasure Systems office that leads efforts to develop and field MCMs for military forces. Finally, the Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, plays a key role in developing and procuring MCMs against a range of biological threats. Several policy frameworks and pieces of legislation also govern US efforts in MCM acquisition, regulation, and distribution. Notable among these is the Project BioShield Act of 2004, which was created to fund development and government procurement of novel MCMs against traditional biological weapons threats such as botulism, anthrax, and smallpox. The FY2016 budget for HHS’s Public Health and Social Services Emergency Fund included $646 million to support Project BioShield activities. The Pandemic and AllHazards Preparedness Reauthorization Act (PAHPRA), enacted in March 2013, authorized further funding for MCM purchasing and advanced MCM research and development efforts through 2018. Additionally, Homeland Security Presidential Directives 10, 18, and 21 (Biodefense for the 21st Century, Medical Countermeasures Against Weapons of Mass Destruction, and Public Health and Medical Preparedness, respectively) underscore the importance of a robust MCM enterprise to national and global health security. With the support of federal policies and legislation, PHEMCE has made many critical contributions to preparedness and response efforts around biological threats. In response to the 2014 Ebola outbreak in West Africa, for example, PHEMCE partners rapidly coordinated efforts to develop and test needed vaccines, therapeutics, and diagnostics. In 2014, PHEMCE partners also procured 4 million additional doses of a next-generation smallpox vaccine, as well as 33,000 doses of a monoclonal antibody against anthrax toxin. Additionally, between 2014 and 2015, FDA approved 2 new influenza products, as well additional MCMs against anthrax, high doses of radiation, and plague. Still, sustaining and furthering national MCM preparedness for biological threats remains a challenge for