Whether an emergency involves a chemical, biological, radiological or nuclear weapon or an improvised explosive device, protecting health requires tremendous coordination among many federal partners. Developing drugs, vaccines, diagnostic tests, and medical devices – collectively known as medical countermeasures – to protect our nation against bioterrorism threats requires more than one federal agency. A range of federal departments and agencies possess relevant knowledge and expertise and have stakes in protecting our national health security.
To help accomplish the complex challenge of developing medical countermeasures that can help protect our nation against these threats, HHS established a coordinated interagency group called the Public Health Emergency Medical Enterprise, or PHEMCE. The PHEMCE brings together the departments of Homeland Security, Health and Human Services, Defense, Veterans Affairs and Agriculture. ASPR has led the PHEMCE since this partnership was formed in 2006. Together, these agencies identify the types of products needed, prioritize development, and collaborate on that development.
Coordination among these agencies has led to the PHEMCE’s success in better positioning our nation to respond to bioterrorism threats, and has aided the U.S. response to emerging infectious disease outbreaks, including Ebola and Zika.
A broad portfolio of products
Because these agencies work together as the PHEMCE, products can receive support in one phase of development from one agency and then transition to support from other PHEMCE partner agencies. Moving these products more seamlessly between federal agencies involves a great deal of coordination but ensures that the medical countermeasures our nation needs to secure public health can complete development successfully.
These medical countermeasures include products that could be used not only to treat patients injured from terrorist attacks using chemical or biological weapons, but also to help protect our nation’s health security from other public health threats, including pandemic influenza, antibiotic resistant infections and newly emerging infectious diseases.
A track record of success
Since this partnership was created, 23 products identified for development through the PHEMCE have been added to the Strategic National Stockpile to be available in the event of a national emergency. ASPR/BARDA sponsored the advanced development of the majority of these critical medical countermeasures.
To better coordinate federal efforts, the PHEMCE leaders meet routinely on policy and procurement and to monitor progress of product development. PHEMCE partners identify challenges to their progress and determine the best way to overcome those challenges, assigning responsibility to ensure action is taken.
Strategic planning
The PHEMCE developed a Strategic Implementation Plan in 2012 to identify key challenges in the lifecycle management and policy needs. The 2012 PHEMCE Strategic Implementation Plan helped frame future contributions and measures of progress for each of the partners.
The innovative approaches that the PHEMCE leaders used in pursuing the mission also led them to create multi-year budgets for developing medical countermeasures. The challenges to successfully developing medical products are great. Products, drugs and vaccines can fail for business, technical, regulatory and governmental reasons. Developing multi-year budgets was one way the PHEMCE could help reduce the barriers medical countermeasures encountered while boosting industry interest in working with the federal government to develop the needed products.
By recognizing that many different agencies invest in the development of medical countermeasures at different points in their lifecycles, establishing a multi-year budget helped bridge gaps that occurred as products moved through development.
Responding to Emerging Threats
As new diseases have emerged, the PHEMCE has proven to be nimble enough to respond. During the Zika response, for example, the National Institutes of Health’s National Institute of Allergy and Infectious Diseases provided expertise in basic and early clinical research while BARDA provided expertise in advanced development and manufacturing to determine which Zika vaccine approaches were most likely to prove effective and therefore worth pursuing.
The PHEMCE also proved to be of critical value in coordinating medical product development in response to the Ebola virus outbreak of 2014-2015.
Protecting national health security
The PHEMCE focuses the federal government’s expertise on protecting our national health security, whether from biodefense threats or emerging infectious diseases.
The return on investments made by PHEMCE partners over the past 10 years has been tremendous. Today, the nation has a greater national response capability; more medical countermeasures are available to aid during a disaster; and we now have a medical countermeasures structure that helps our nation deliver the products needed during a public health emergency.
