Emerging Issues The SNS continues to occupy a critical position in the response plans of local, state, and Federal authorities for dealing with major crises involving medical intervention. The plans, policies, and procedures for its use have continued to be modified since its inception in 1999 and remain the subject of new proposals on an ongoing basis. Recent issues include: USPS Delivery. On February 18, 2004, the U.S. Postal Service (USPS) announced developing plans to deliver antibiotics from the stockpile directly to residential addresses in the event of a catastrophic incident. 30 With assurances that the procedures under consideration would only augment existing state and local plans, HHS has touted the vast USPS infrastructure as a primary catalyst for the “doorstep delivery” campaign. While home delivery would likely reduce the crunch on the public health system and even stem the “worried well” of panicked civilians, the resulting legal issues would be immense. Proper labeling and safety guidelines would need to be prepared in advance. Pervasive public education would become even more critical, and postal workers may need incentives to volunteer. Moreover, releasing large quantities of unsupervised antibiotics could have devastating effects on drug potency, and a stringent decision-making process must be in place to prevent delivery in circumstances short of national disaster. Project Bioshield. In his 2003 State of the Union Address, the President announced Project Bioshield. 31 This initiative may significantly impact the future content of the stockpile and its use to support the medical response to an incident in the United States. The primary focus of Project Bioshield is to develop and make available modern, effective drugs and vaccines to protect against attack by chemical and biological weapons or other dangerous pathogens. The initiatives announced to date include: strengthening National Institutes of Health (NIH) development capabilities by speeding research and development on medical countermeasures; ensuring that resources are available to pay for next-generation medical countermeasures; and giving the FDA the ability to make promising treatments quickly available in emergency situations. The first two initiatives are designed to provide new medical components that may be used in the stockpile, but these will not be available for some considerable time. Of more immediate potential value for the stockpile is the possibility that the FDA can enable existing drugs to be used in emergency situations for medical conditions beyond their current labeling and license. The agency can also use an expedited process to enable promising drugs to be available for use in a crisis, providing they meet the criteria for safety and presumed efficacy. The United States Senate’s unanimous approval of Project Bioshield on May 19, 2004 was a critical step toward enlisting the biotechnology community in the fight against biological and chemical weapon attacks. Together with ongoing discussions in which the author and the director of the Center for Technology and National Security Policy have engaged Congress, Project Bioshield will be an integral component of how the SNS is modified in coming months. The next step will be to ensure better liability protections for companies that choose to develop biomedical countermeasures without FDA approval. Senators Joseph Lieberman, D-Conn., and Orrin Hatch, R-Utah, have already begun work on a bill (Bioshield II) to address this concern. 32 Private-Public Partnerships. The 21-year-old group Business Executives for National Security, or BENS, seeks to address the difficulties of local SNS distribution. Through its “Business Force” initiative, BENS is working with New Jersey county governments to initiate a proof-of-concept exercise that would show how businesses could play a vital role in distributing vaccines and other needed medical supplies during a terrorist attack. Two member companies in cooperation with two New Jersey county governments will create a plan, work through roadblocks (such as liability), and test the plan with an exercise that engages business as well as the state and local government. BENS has identified many counties that do not have adequate plans in place for distribution and dispensing, or lack the facilities and staff to do so. Using businesses as “points of dispensing” could remedy this deficiency and save lives. The success of the project may indicate one direction that state and local authorities can take to address the logistical burden of distributing the stockpile during a future incident. 30.United States Postal Service - News Release No.
04-015—Available at www.usps.com/communications/news/press/welcome.htm.
Accessed February 2004.
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