HHS releases plan for development and purchase of medical countermeasures

Apr 19 2007

HHS Secretary Mike Leavitt has released for display in the Federal Register the Department's new roadmap for developing and purchasing medical countermeasures against a host of chemical, biological, radiological and nuclear (CBRN) threats.

The "Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats" lays out the future course for prioritizing HHS' acquisition of vaccines, drugs and medical diagnostic tests, including purchases made under Project BioShield. The plan will be published in the Federal Register Friday, April 20 and be posted online at http://www.hhs.gov/aspr/ophemc.

"Since the terrorist attacks of September 11, our mission has been to protect Americans by securing medical countermeasures for a range of threats. We have made significant progress to increase our preparedness in this area, but there is much more we must do," Secretary Leavitt said. "This plan lays out our path forward in the coming years and will take advantage of our new authorities under the Pandemic and All-Hazards Preparedness Act to move forward with Project BioShield."

The PHEMCE plan assesses the current state of medical countermeasure preparedness, and identifies the highest priority research, development and acquisition programs to increase public health emergency preparedness. The plan further identifies the proposed acquisitions HHS plans to make under Project BioShield during the remaining five years of the program as well as priority medical countermeasure programs that will be pursued up through Fiscal Year (FY) 2023.

In addition, the plan emphasizes the importance of using the new authorities provided for Project BioShield under the Pandemic and All-Hazards Preparedness Act to support the research, development, acquisition, and availability of safe and effective medical countermeasures to protect the United States from CBRN threats. Appropriate advanced development funding will also be critical to the future success of these activities.

Funding support by the National Institutes of Health for basic research, product development, and clinical research of CBRN medical countermeasures has grown over thirty-fold from FY 2001 to FY 2006. Funding for the Strategic National Stockpile has increased over ten-fold in that same period. This dramatic growth in funding has led to the acquisition and stockpiling of medical countermeasures and supplies to protect the American public when public health emergency needs exceed or are otherwise unavailable through local supplies.

The public will be able to submit comments on the PHEMCE Implementation Plan through the Federal Register. Furthermore, HHS will hold a Public Health Emergency Medical Countermeasures Enterprise/BioShield Stakeholders Workshop on July 31-August 2, 2007 in Washington, D.C., to provide an opportunity for feedback and discussion of the plan. The workshop is an open meeting that will bring together representatives of the pharmaceutical and biotechnology industries, professional societies, state and local public health organizations, the academic research and development community, public interest groups, stakeholder federal agencies and Congress.

Additional information on the PHEMCE Strategy and Implementation Plan, Stakeholders Workshop and Project BioShield is available online at