Christina England, Master’s Candidate, Security Policy, University of Maryland School of Public Policy; Intelligence Officer, United States Air Force

One of the weakest U.S. bioresponse capabilities is the U.S. medical countermeasure (MCM) enterprise. Few in the fields of public health or biodefense would be surprised to hear that the U.S. is unprepared to respond to a virus for which no medical countermeasures exist. Additionally, bioweapons made resistant to U.S. medical countermeasures would also be catastrophic. Though all seven of the U.S. bioresponse capabilities – detection and diagnosis, attribution, communication, MCM development, MCM dispensing, medical management, and environmental cleanup – are essential in addressing both naturally occurring disease and man-made outbreaks, current stockpiles of MCMs are not adequate for large-scale attacks nor attacks that utilize resistant or novel pathogens. The medical countermeasure enterprise consisting of the development and distribution of MCMs is a significant liability in the U.S. bioresponse process.

Medical countermeasures include both pharmaceutical interventions like vaccines and antimicrobials as well as non-pharmaceutical interventions like ventilators and personal protective equipment (PPE) that may be used to prevent, mitigate, or treat the adverse health effects of an intentional, accidental, or naturally occurring public health emergency. Project Bioshield, reauthorized in 2013 to allocate $2.8 billion to the Biomedical Advanced Research and Development Authority (BARDA) over the next five years to procure MCMs, guarantees that the government will buy a certain quantity of MCMs at a predetermined price. As of January 2013, the U.S. had purchased from seven different pharmaceutical companies eight MCMs for the Strategic National Stockpile that address anthrax, smallpox, botulinum toxin, and radiological threats. So long as current funding levels are maintained, which is unfortunately questionable, BARDA envisions the procurement of 12 additional MCMs over the next ten years.

Despite Project Bioshield having been spared from sequestration, a variety of issues still plague the MCM enterprise. Of all the components of the MCM enterprise, improvements still need to be made to the HHS’ Public Health Emergency Medical Countermeasures Enterprise in its structure, priorities, and funding; MCM production in its contracting and regulatory processes; and MCM dispensing in its timeliness, logistics, and points of dispensing. It is the problems in these particular areas that, if not altered, can pose the most serious liability to U.S. MCM biopreparedness. While the current MCM enterprise led by HHS has taken extraordinary steps in manufacturing valuable vaccines, there are a multitude of diseases that still do not have a countermeasure. Also, if a pandemic were to strike, the ability of all levels of government to dispense countermeasures to the public in a timely, orderly fashion is questionable. By adopting measures that enhance the medical countermeasure production and distribution capabilities, thousands of lives could be saved in the case of a large-scale biological event.

1. This article is based on research carried out while with the Federation of American Scientists. For a more in-depth look at the challenges facing the medical countermeasures enterprise, see: Christina England, “The United States Medical Countermeasure Enterprise: A Broken Link in US Biopreparedness,” Journal of Homeland Security and Emergency Management, Volume 0, Issue 0, Pages 1–14, ISSN (Online) 1547-7355, ISSN (Print) 2194-6361, DOI: 10.1515/jhsem-2013-0043, January 2014.