Project BioShield, a 10-year $6-billion program to develop and produce new vaccines and countermeasures against potential bioweapons, would give the National Institutes of Health (NIH) new authority to bypass traditional procedures when awarding urgently-needed research and development grants and contracts and allow the Food and Drug Administration (FDA) to distribute experimental drugs in case of a bioterrorist attack or other emergency.

The initiative to develop vaccines and treatments for smallpox, anthrax, Botulinum toxin, Ebola, and plague was first announced by President Bush in his State of the Union address Jan. 28. He proposed funding of $6 billion over the next 10 years for the effort. This week, the White House released additional information on how the new plan, which is subject to legislative approval, would work. The proposal includes three main components:

Spending authority for "next-generation" vaccines and countermeasures. The plan gives the federal government "permanent indefinite funding authority" to spur development, as well as purchase "huge amounts," of vaccines or drugs to treat smallpox, anthrax, Botulinum toxin, and other pathogens. "We already have the knowledge and ability to manufacture some of the vaccines and drugs we need," Bush told an audience at NIH Monday. "We must now develop and stockpile these vaccines and these treatments."

US manufacturers are reluctant to produce vaccines when there are no guaranteed buyers, and the two main therapies used to treat anthrax are currently produced overseas, Bush noted. "We must rebuild America's capacity to produce vaccines by committing the federal government to the purchase of medicines that combat bioterror," he said.

NIH authority to speed R&D. The director of the National Institute of Allergy and Infectious Diseases (NIAID) would have increased authority and flexibility to award R&D contracts and grants, rapidly hire technical experts, and quickly procure items needed for research. NIH's traditional funding methods "may not always be suited to meet the urgent demands" posed by bioterrorism, a White House statement explained, and when appropriate, "expedited peer review procedures" could be used.

"Our labs will be able to hire the experts, get more funding quickly, and build the best facilities to accelerate urgently needed discoveries," Bush said.

FDA emergency-use authorization. Because some of the most promising treatments against bioterror agents may be under formal FDA review when an attack occurs, BioShield would give FDA special power to authorize use of these treatments in an emergency if alternatives are not available. This authority, subject to a risk-benefit determination by the secretary of Department of Health and Human Services, would include only drugs under direct control of the government and civilian use of such drugs would be voluntary.

"Project BioShield will have many applications beyond its immediate goals," Bush added. "As scientists work to defeat the weapons of bioterror, they will gain new insights into the workings of other diseases. This will also break new ground in the search for treatments and cures for other illnesses. This could bring great benefits for all of humanity, especially in developing countries where infectious diseases often go uncontrolled."