The White House, President George W. Bush Click to print this document

For Immediate Release
Office of the Press Secretary
February 3, 2003

President Details Project BioShield


  • In his State of the Union Address, President Bush announced Project BioShield -- a comprehensive effort to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens. Project BioShield will:


  • Today, the country is better prepared than ever to meet the threat of terrorist attack with a biological, chemical, radiological or nuclear agent. The national stockpile of medical countermeasures is more extensive and can be accessed more rapidly than ever, and additional diagnostic tests, drugs, and vaccines are under development.

  • But, the possibility of the intentional use of biological or other dangerous pathogens represents a threat to our society. Unfortunately, the medical treatments available for some types of terrorist attacks have improved little in decades, while there has been tremendous and rapid progress in the treatment of many serious naturally-occurring diseases.

  • The President believes that, by bringing researchers, medical experts, and the biomedical industry together in a new and focused way, our Nation can achieve the same kind of treatment breakthroughs for bio-terrorism and other threats that have significantly reduced the threat of heart disease, cancer, and many other serious illnesses. The President's Project BioShield has three major components:

    1. Spending Authority for the Delivery of Next-Generation Medical Countermeasures. The President proposed the creation of a permanent indefinite funding authority to spur development of medical countermeasures. This authority will enable the government to purchase vaccines and other therapies as soon as experts believe that they can be made safe and effective, ensuring that the private sector devotes efforts to developing the countermeasures.

    2. New NIH Programs to Speed Research and Development on Medical Countermeasures. The President proposed to give the NIH new authorities to speed research and development in promising areas of medical countermeasure development. NIH's usual methods for supporting research and development on conventional diseases have been extremely effective in those areas but may not always be suited to meet the urgent demands posed by the risk of terrorism. The new authorities would apply only to support research and development on bioterrorism threat agents and include the following features:

    3. New FDA Emergency Use Authorization for Promising Medical Countermeasures Under Development. Some of the most promising treatments for a terrorist agent may still be under formal FDA review when an attack occurs. The President proposed an emergency use authorization to permit the effective use of such treatments in an emergency, if alternative treatments are not available. This will improve access to a potentially beneficial treatment in an emergency situation, when it is most likely to save lives, even if it has not yet been proven to be suitable for routine general use or has not completed the formal process for full FDA licensure.

  • Scientific breakthroughs such as recombinant DNA technology, immunology, molecular structural engineering, genomics, and proteomics that are now protecting our health from many conventional diseases hold considerable promise against the diseases of terrorism as well. This same innovation can be applied to the challenge of protecting America by identifying the new treatments that are most needed, and providing meaningful and consistent rewards for innovators who bring these products to the American public. And, the breakthroughs resulting from Project BioShield are likely to have important spillover benefits in diagnosing and treating other diseases, and in strengthening our overall biotechnology infrastructure.

    For more information on the President's initiatives, please visit

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