Publications
National Health Security Strategy 2019-2022
Our nation faces diverse and evolving health security threats that have the potential to disrupt our public health and health care systems and inflict injury and loss of life on our people. Significant progress has been made in improving capabilities to address the immediate public health…
National Biodefense Strategy 2018
It is a vital interest of the United States to manage the risk of biological incidents. In today’s interconnected world, biological incidents have the potential to cost thousands of American lives, cause significant anxiety, and greatly impact travel and trade.
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 2017-2018
The U.S. continues to face a range of serious threats to its health security from the unintentional release or deliberate use of chemical, biological, radiological, and nuclear (CBRN) agents, as well as naturally occurring emerging infectious diseases (EID), including pandemic influenza.
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 2016
Considering the progress achieved and the remaining strategic gaps in MCM preparedness, the PHEMCE annually examines the SIP goals and objectives and re-adjusts or adds to them, as needed.
Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop Report 2016
The goal of the 2016 PHEMCE Stakeholders Workshop was to provide a forum within which a broad spectrum of stakeholders in the PHEMCE mission of effective provision of emergency medical countermeasures could learn about PHEMCE activities, interact, and provide input to PHEMCE partners about their interests, issues, concerns, and priorities.
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 2015
The United States (U.S.) continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological, radiological, and nuclear (CBRN) agents, as well as from naturally occurring and emerging infectious diseases (EID), including pandemic influenza. Since the development of the 2014 PHEMCE SIP, the PHEMCE has made significant progress in achieving the priorities described in the 2014 PHEMCE SIP.
Project BioShield Report 2014
Significant progress was made in 2014 in the regulatory review and approval of MCMs procured under Project BioShield.
PHEMCE Strategy and Implementation Plan 2014
The United States continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological, radiological, and nuclear (CBRN) agents, as well as from naturally occurring and emerging infectious diseases (EID), including pandemic influenza.
Project BioShield Annual Report 2013
The Project BioShield Act of 2004 [Project BioShield (PBS); Public Law [P.L.] 108-276] amended the Public Health Service (PHS) Act and the Federal Food, Drug, and Cosmetic (FD&C) Act to provide additional & more flexible authorities and funding to support financially the development and procurement of medical countermeasures against chemical, biological, radiological, and; nuclear (CBRN) threat agents. It was also designed to provide the government authority to quickly authorize use during emergencies.
Project BioShield Annual Report to Congress 2012
The Medical Countermeasures (MCM) Enterprise had a significant year in 2012. The U.S. Department of Health and Human Services' (HHS) continued to leverage recommendations of the "Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs" (MCM Review), released in August 2010, to foster and promote capabilities to prepare and respond to a wide range of threats while balancing limited resources.
PHEMCE Implementation Plan 2012
The 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan describes the priorities that HHS, in collaboration with its interagency partners, will implement over the next five years to advance the strategic goals and underlying objectives established in the 2012 PHEMCE Strategy.
Priorities are identified along the near- (Fiscal Year [FY] 12-14), mid- (FY15-17), and long-term (FY18 and beyond) timeframes where appropriate.
PHEMCE Strategy 2012
The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents (e.g., weapons that could be used to kill or injure a large number of people) and emerging infectious diseases (EID) (e.g., 1918-19 influenza pandemic outbreak).
BARDA Strategic Plan
The nation has endeavored over the past ten years to become better prepared for the medical consequences of catastrophic events such as bioterrorist events and pandemic influenza. During that time period Project BioShield, The National Strategy for Pandemic Influenza, and the Biomedical Advanced Research and Development Authority have emerged to support the development and acquisition of medical countermeasures (MCMs) and the domestic manufacturing capacity to prepare for and respond to an emergency.
Project BioShield Annual Report to Congress 2011
The medical countermeasures pipeline has never held more promise than it does today. Innovation, enhanced partnerships and collaboration, and sustained investments throughout the last decade have resulted in the addition of eight new countermeasures in the Strategic National Stockpile (SNS ), able to treat the effects of anthrax, botulism, smallpox, and radiological and nuclear agents.
Public Health Emergency Medical Countermeasures Enterprise Review
Emerging infectious diseases, pandemics, and bioterrorism carry the potential for catastrophic impact, and the U.S. government has faced chronic challenges in producing medical countermeasures against such threats, as exemplified during the recent 2009-H1N1 pandemic. The President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need.