It’s true. Making sure the nation has the drugs, vaccines, and medical devices needed to protect health in an emergency requires more money, authority, and technical expertise than any one federal agency has alone. But by collaborating, federal agencies are making it happen. Take the Ebola outbreak as a recent example.
As the Ebola outbreak spread to multiple countries in West Africa and became a public health emergency of international concern, federal agencies in the United States pulled together to review quickly, the vaccines, diagnostics, and therapeutics the agencies were supporting. Collectively known as medical countermeasures, these products were in various states of early development; none had reached clinical trials.
The agency representatives made fast decisions about how to use the authority, funding, and technical expertise from each agency to move as many products, as rapidly as possible, into clinical trials and get them into the hands of doctors and patients to prevent or treat this deadly infection.
That collaboration, speed and empowerment is the beauty of the Public Health Emergency Medical Countermeasure Enterprise, or PHEMCE. In one way or another, all of the agencies involved in the PHEMCE, support the development of medical countermeasures for military or civilian use or both.
This group plans together to be sure that development takes place as fast as possible without funding redundant efforts, and that there aren’t gaps in addressing health threats from chemical, biological, radiological or nuclear agents. That’s where the PHEMCE Strategy and Implementation Plan come into play.
Like all strategies, the PHEMCE Strategy and Implementation Plan published this month identifies goals and objectives. This one also describes the activities and programs these agencies will undertake to have the medical products our nation will need when confronted with health threats from chemical, biological or rad/nuc incidents, whether from bioterrorism or naturally occurring incidents like this current Ebola epidemic.
The Strategy and Implementation Plan becomes a business plan that these agencies follow in the near-term and long-term to make the best use of available resources to enhance national health security.
Through the PHEMCE, HHS was able to estimate the funding requirements for NIH, ASPR, FDA, and CDC to pursue medical countermeasure development and purchase in fiscal years 2014-2018, and provided this information to Congress. Agency-specific spending in these years is estimated to be: NIH/NIAID - $9.2 billion; ASPR/BARDA - $5.0 billion; CDC/SNS - $3.1 billion; and FDA - $13.7 million. The out-year funding estimates (FY 2017 & 2018) included in the report were developed without regard to the competing priorities that are considered in the annual development of the President’s Budget and must be considered as budget submissions to Congress are developed in these out-years. So these estimates are subject to change in the future.
The Strategy and Implementation Plan also evaluates progress against the group’s previous priorities, describes progress in developing products to meet the medical needs of at-risk populations, summarizes the development that’s underway, and outlines what’s been purchased by the agencies and now available to local communities in a public health emergency.
The drugs, vaccines, and medical devices doctors prescribe or use every day require years, often decades, to develop, and private industry spends billions of dollars bringing these products to market. For each product that reaches the market, eight others failed because the science just didn’t work. Developing products needed for public health emergencies can be even more difficult.
Yet, by collaborating through the PHEMCE, federal agencies have made tremendous progress. More than 160 products have reached advanced development stages; a dozen types of products have been added the Strategic National Stockpile in just eight years, and since 2012, FDA has approved eight new products from our pipeline. These products will help combat pandemic influenza viruses and other emerging infectious diseases, anthrax, smallpox, botulism, radiological and nuclear events, and chemical nerve agents.
To ensure the safest and most effective use of limited medical countermeasures following an attack, PHEMCE partners developed up-to-date clinical guidance for using anthrax countermeasures in children, pregnant women, and the general population under mass casualty conditions. They did the same for products that would be used in a mass casualty incident involving botulism or to treat blood-related injuries after a radiological or nuclear incident.
That’s just a snapshot. Learn more about what’s being done under the 2014 PHEMCE Strategy and Implementation Plan.
