In today’s emergency response landscape, public health jurisdictions across the United States rely on the Strategic National Stockpile (SNS) when incidents prove large enough or severe enough to deplete medicines and supplies needed to protect communities. In just 20 years, the SNS – now managed by the U.S. Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR) – has grown to a $7 billion enterprise poised to respond to a variety of public health threats. These threats include anthrax, botulism, smallpox, plague, tularemia and viral hemorrhagic fevers, as well as emerging infectious diseases, pandemic influenza, natural disasters, and other chemical, biological, radiological, and nuclear incidents. Although predicting the future of any program is challenging, the SNS has evolved from humble beginnings to a formidable component of national security.
Early discussions about establishing a federal stockpile of medical products centered around planning for the year 2000 – commonly called Y2K – amid fears of terrorist attacks significant enough to cause healthcare facilities to run short on supplies. In January 1999, Congress charged HHS and the Centers for Disease Control and Prevention (CDC) with creating a repository of medical countermeasures (MCMs) for use in the event of a chemical or biological terrorist attack on U.S. civilian populations. This repository was initially named the National Pharmaceutical Stockpile.
Building the Stockpile Piece by Piece
With a $51 million appropriation and a handful of public health professionals quietly housed in CDC’s National Center for Environmental Health, the program expanded systematically to meet Congress’ intent to protect the American people. Within one month, the stockpile was augmenting the National Medical Response Team’s inventory by providing funds to HHS to procure and forward-position treatments and antidotes for up to 10,000 individuals if a nerve agent release occurred. This effort ultimately became today’s CHEMPACK program, a far-forward-placed stock of medicines to respond to chemical nerve agent attacks or incidents involving organophosphorus pesticides.
Using the 1999 HHS Anti-Bioterrorism Operating Initiative as a starting point for which threat agents to address, stockpile personnel developed concepts for the 12-hour Push Package – a broad spectrum of medicines and supplies for an unidentified threat – and vendor-managed inventory. They began meeting with external subject matter experts to review potential threats and recommended treatments. At the same time, CDC hosted a similar meeting with its Bioterrorism Preparedness and Response Program concerning biological threat agents. From these meetings, stockpile personnel initiated the development of the early formulary and the medical materiel requirements deemed necessary to protect the United States from a growing list of threats. By September 1999, the stockpile finalized its first total requirements list. Then, on 27 December 1999, the stockpile readied its first 12-hour Push Package to respond to a potential Y2K terrorist incident.
The one-year mark proved a busy time for the budding stockpile. The program established transportation contracts to move stockpiled assets, if needed, and created its Program Planning, Response and Training Team to work with HHS emergency coordinators in the field to ensure planning efforts were well-coordinated and integrated with activity at the state and local levels. Personnel were writing and establishing initial development contracts for new smallpox and anthrax vaccine and new botulism antitoxin to include in the stockpile, and they served as project officers for the development of these pharmaceuticals.
Over time, stockpile staff continued to adjust the formulary and build and configure the 12-hour Push Packages. They worked with warehouse vendors and transportation partners to establish some early processes and procedures that have been tested and refined for use by the SNS today. In September 2000, the Food and Drug Administration (FDA) granted approval for the stockpile to participate in the FDA/Department of Defense (DoD) Shelf-Life Extension Program (SLEP). Originally, SLEP was viewed simply as a method to save money. Today SNS continues to use SLEP to maximize returns on investment by holding MCMs for as long as possible while ensuring stability and potency. SLEP also allows the SNS program to build up stock over time to reach the full quantities needed to protect Americans. This benefit is especially important because some stockpiled products are produced in such low quantities and have such short shelf life that otherwise would prevent the program from meeting its overall preparedness goals.
Testing Stockpile Response Capabilities
One of the stockpile’s first collaborative efforts with emergency response planning was working with the New York City Department of Emergency Operations and the Federal Aviation Administration. On 11 September 2001, one month after the three organizations staged their first full-scale exercise, an early morning attack on the World Trade Center and the Pentagon confirmed the country’s worst fears. The stockpile was called into action as part of the government’s immediate response to the deadliest terrorist attack on U.S. soil. Within seven hours of the order to deploy to New York City, the stockpile delivered by both ground and air cargo a 12-hour Push Package of medicines and supplies as well as ventilators, ancillary supplies, and burn-and-blast supplies. The delivery was met by a response team of stockpile experts called a Technical Advisory Response Unit, which was able to deploy to New York via chartered aircraft. On that day, the only other non-military flight in U.S. airspace was Air Force One.
On the heels of 9/11, the stockpile was called upon again to respond to a series of anthrax attacks and subsequent inhalation anthrax cases in the United States. Using its vendor-managed inventory capability, the stockpile responded to 65 separate drug requests for post-exposure prophylaxis, all of which were filled within an average of five hours from initial contact to delivery.
The events of 2001 shed light on the need to strengthen national public health preparedness and response efforts. Immediately following these two responses, the stockpile rapidly expanded with both inventory and appropriations. The HHS secretary directed the stockpile to increase its capacity to provide full post-exposure prophylaxis for anthrax for up to 12 million people. The number of 12-hour Push Packages grew from eight to 12. Congress appropriated $643 million for the stockpile in FY 2002 to fund these initiatives as well as to run a state preparedness grant program, to establish packages of chemical nerve agent antidotes and antibiotics, and to grow the program to a team of 79 personnel.
Expanding the Stockpile for an All Hazards Approach
During the next two years, the stockpile developed and solidified partnerships across the federal interagency community as well as with private warehouse and transportation organizations. The program was granted responsibility for the transport of existing and future supplies of botulism antitoxin and anthrax vaccine as well as for storing and transporting the nation’s current and future supplies of smallpox vaccine. Stockpile experts were looking to improve speed and efficiency and worked with private sector partners to design the first specialized cargo containers for the 12-hour Push Package. In this timeframe, the stockpile also created a pilot program called CHEMPACK, which placed federally owned and managed nerve agent antidotes in forward locations selected by local authorities to integrate with their hazardous material response plans. Fast forward 20 years and the SNS remains ready today to respond to chemical nerve agent incidents through CHEMPACK, which has forward placed more than 1,900 containers of antidotes at more than 1,300 locations across the United States and its territories.
While the stockpile was expanding its mission and role in storing and transporting critical products for national health security, staff was developing a comprehensive training and exercise program to ensure state and local health jurisdictions were ready to receive, distribute, and dispense these products in an emergency. Internally, the program was implementing a professional inventory and financial tracking system to provide a real-time capability to manage SNS assets and mission readiness. With continual updates, this system is still used by the SNS to integrate financial and inventory information and to ensure inventory accountability, reconciliation, and financial reporting.
On 1 March 2003, the Homeland Security Act of 2002 took effect, and the stockpile was transferred from HHS to the Department of Homeland Security (DHS). At the same time, the National Pharmaceutical Stockpile was renamed the SNS to reflect its evolving formulary to store more than just pharmaceuticals, but also medical supplies and devices earmarked for public health emergencies. Additionally, formulary governance in the early years was established by the stockpile via the creation of the Intragovernmental Committee, chaired by CDC’s associate director for science and made up of members from various federal organizations including HHS, CDC, FDA, DoD, and DHS.
By the close of 2003, the stockpile program had increased staffing to 120 employees and contractors. The staff grew with specialists in public health, emergency response, and, importantly, now professional medical logisticians. The annual appropriation hovered around $300 million, there were a dozen 12-hour Push Packages in 10 sites across the nation, and the stockpile was positioned to provide up to 12 million people with a full 60 days of post-exposure prophylaxis if faced with a large-scale anthrax response. Also, the stockpile added 400,000 doses of antiviral drugs to its formulary in preparation for a pandemic influenza. This was the first procurement for the formulary beyond the original mission focused on terrorist incidents and represented an entirely new and different scope.
When Project BioShield – a program to expedite late-stage development and procurement of next generation vaccines and other MCMs against a range of potential terrorist weapons – became law on 21 July 2004, the SNS returned to HHS. Under this new legislation, the SNS was designated as the procurement and storage partner for Project BioShield and would manage the delivery of products in a bioterrorist attack or other emergency. The SNS remains with HHS today, although the program transferred from CDC to its current place in ASPR in October 2018.
In the program’s first five years, the SNS grew from a small organization with a modest budget and a handful of staff to a robust and critical piece of federal preparedness and response. Real-world incidents tested the stockpile’s capabilities, and state and local jurisdictions worked in concert with stockpile experts on major planning initiatives. These early achievements set the course for the next 15 years as the SNS evolved to broaden its focus to serve as the nation’s resource for protecting the public’s health.
This article is the first of a three-part series:
Part 2 (published in November 2019): Evolving the Scope of the Strategic National Stockpile
Part 3 (to be published in December 2019)