Following the events of 9/11, Congress enacted Project BioShield to expand the U.S. stockpile of medicines and vaccines, referred to as medical countermeasures, to protect against potential chemical, biological, radiological and nuclear (CBRN) attacks. BioShield was conceived to increase biopharmaceutical research and development for CBRN countermeasures and incentivize participation by companies to develop products that otherwise have no commercial market. Project BioShield was enacted into law in 2004 and Congress appropriated $5.6 billion over ten years to procure such countermeasures.
The Congress and the president recently took a very important step in perpetuating Project BioShield by passing and signing the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization, which authorizes an additional $2.8 billion for Project BioShield over the next five years.
BioShield’s ultimate funding level, however, is now subject to the annual appropriations process. The question is this: will Congress will provide the funding?
In light of the nation’s difficult fiscal challenges, it would be easy to cut or eliminate federally funded government programs that have failed or are marginally working. But surprisingly, Project BioShield is not one them. It is a program that has proved to be a success.
In the eight years since its inception, BioShield funds have bought eight medical countermeasures against anthrax, smallpox, botulinum toxin and radiological threats and funded development of 80 other candidates. Five of these countermeasures are licensed for use by the FDA, and three others are expected to receive FDA licensure by 2016.
Because of Project BioShield, our nation has a strategic stockpile of more than 50 million doses of vaccines and drugs against several CBRN threats. There is, however, the real possibility that Congress may choose not to fully fund it. In light of current events and the program’s track record, this would be “penny wise and pound foolish.”
BioShield investments have the dual benefit of not only potentially saving lives in the event of CBRN attacks but also advancing science applicable to other areas of medicine and public health. True to Congress’ original intent, BioShield has incentivized over 80 companies to develop medical countermeasures by providing a guaranteed market for their products should they successfully demonstrate their safety and effectiveness. This emerging biotechnology sector has created new jobs and spawned innovation that has benefited the larger pharmaceutical industry in vaccine and drug development, medical diagnostics and medical devices.
The public-private partnership created by Project BioShield has not only enhanced our national security by increasing our preparedness -- it has resulted in increases in investment and innovation in medical countermeasures that can benefit the broader society.
In light of growing global instability and the diffusion of capabilities that offers states, disaffected groups and individuals with the means to conduct CBRN attacks, the national security partnership created by Project BioShield is a strategic hedge against an uncertain future. The $2.8 billion that Congress authorized over five years for Project BioShield is an indispensable insurance policy against potential CBRN attacks.
Kadlec, a consultant with RPK Consulting, LLC. He served as special assistant to the president and senior director for Biodefense Policy during the George W. Bush Administration.