While the September 11, 2001 attacks on the World Trade Center and Pentagon ushered in the era of terrorism as the nation’s primary security threat in the post-Cold War era, it was the October 2001 mailing of envelopes containing Bacillus anthracis spores to several locations in the U.S. that raised the specter of the use of biological weapons to kill civilians on a large scale. Many countries named by the U.S. State Department as sponsors of terrorism are believed either to possess or to be actively pursuing biological weapons.1 Most recently, it has been reported that North Korea is moving steadily to acquire the essential machinery and scientific expertise that could potentially be used for an advanced bioweapons program.2
Thought leaders such as Bill Gates have warned that a pandemic, whether caused by a terrorist or nature itself, is one of the biggest threats our nation faces.3 And importantly, the American public has expressed concern as well. The Alliance for Biosecurity, the Blue Ribbon Study Panel on Biodefense, and Trust for America’s Health found in a survey that eight out of 10 Americans are concerned that naturally-occurring diseases like Ebola and Zika pose a threat to the U.S., and about nine out of 10 people are concerned that terrorists might use chemical or biological weapons against the U.S. Importantly, the survey found that most Americans support increasing the federal budget for preventive measures for biological threats.4
About nine out of 10 people are concerned that terrorists might use chemical or biological weapons against the U.S.
Preparedness against a chemical, biological, radiological, or nuclear (CBRN) threat requires a sustained and multi-pronged approach by both the public and private sectors. An essential component of this strategy is the development, procurement, and stockpiling of diagnostic tests, drugs, and vaccines in response to a potential event, as well as the ability to distribute these products where needed. To address this critical need, Congress passed the Project BioShield Act in 2004 to encourage the development of CBRN medical countermeasures by private manufacturers. Project BioShield created a government-market guarantee by providing a 10-year appropriation permitting the secretary of Health and Human Services (HHS) to obligate funds to develop and purchase medical countermeasures for stockpiling by the government. These products are added to the Strategic National Stockpile (SNS), managed by the Centers for Disease Control and Prevention (CDC). The act also establishes a process for the HHS secretary to temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval.5
Over the last 13 years, Project BioShield has facilitated the procurement of 27 medical countermeasures against Department of Homeland Securityidentified national security threats, including products for smallpox, anthrax, botulinum, radiologic/nuclear emergencies, and chemical events. Of these, six products have received FDA approval.6 However, gaps in preparedness remain. In particular, the transition from multi-year to year-over-year appropriations has raised questions about the sustainability of the program. Meeting the continued threat will require a joint commitment from both the public and private sectors.
This white paper will summarize the progress to date in procuring medical countermeasures and prior congressional funding mechanisms for Project BioShield. It will also discuss ways to optimize funding for medical countermeasures so that the existing public-private partnership can continue to thrive: namely, by restoring the program’s original multi-year funding structure.