Health Law and Regulation

HHS has issued a report stating its progress in implementing Project BioShield. HHS has used Project BioShield authorities to support, facilitate and expedite the research, development, acquisition and availability of medical countermeasures to respond to the adverse effects of public health emergencies involving chemical, biological, radiological and nuclear threats.

The report notes that improving public health preparedness is an ongoing process as science advances, innovations mature, and the threat scope changes. To achieve this goal, HHS will continue to use Project BioShield and other authorities to research, develop, acquire, store, maintain, deploy and utilize medical countermeasures to enhance public health preparedness.

The Project BioShield Act of 2004 provided HHS with unique authorities to support the development and acquisition of medical countermeasures as part of a national strategic effort to prepare for threats to public health from chemical, biological, radiological or nuclear events. The Pandemic and All-Hazards Preparedness Act (PAHPA), enacted in December 2006, provided additional authorities to support advanced development of medical countermeasures, including Project BioShield acquisitions. PAHPA also established the new offices of the ASPR and of the Biomedical Advanced Research and Development Authority (BARDA). HHS utilized the new authorities under PAHPA for the first time to make milestone payments in a $500 million Project BioShield contract for development of a new smallpox vaccine, Modified Vaccinia Ankara (MVA). The new vaccine is expected to be effective for people with compromised immune systems.

During the reporting period, HHS awarded five research grants in August and September 2006, for which review had been expedited under Project BioShield authorities. These grants, worth approximately $4 million and awarded to national laboratories and universities, were for research on decorporation agents, which can reduce exposure to radioactive substances by aiding their elimination from the body. Review was also expedited for research grant applications for medical countermeasures to restore gastrointestinal function after radiation exposure.

The HHS Public Health Emergency Countermeasures Enterprise (PHEMCE) is an interagency organization through which HHS coordinates Project BioShield and other public health preparedness efforts, with participation of other federal departments and offices, to assure efficiency and effectiveness in the development and acquisition of emergency medical countermeasures. The HHS PHEMCE Strategy and the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats express the priorities and plans for pursuing these goals over near-, mid-, and long-term time frames.

Source: U.S. Department of Health and Human Services, July 9, 2008

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