would require development of an integrated national process, as described above. The committee offers two options for implementation of this recommendation:

  1. Develop an integrated management structure within the federal government and provide purchase guarantees, analogous to farm commodity loans, to vaccine manufacturers that are willing to develop the needed capacity.

  2. Build government-supported research and development and production facilities, analogous to the National Cancer Institute's program for cancer therapeutics and the federal space, energy, and defense laboratories. The assigned mission of these new facilities would be vaccine development for future infectious disease contingencies.


Since the 1940s, antimicrobial agents have served to control many previously life-threatening infections. Antimicrobials have the unique ability to cure certain diseases, to provide prophylaxis for others, and to reduce sources of infection. The usefulness of these drugs must be protected by careful and responsible use, and by continuing to encourage the development of new antimicrobial drugs. The development of resistance by microorganisms (see Chapter 2), as well as the emergence of new organisms, will require replacement drugs to be in the pipeline even while existing drugs are still effective. Success depends on the alertness of the clinical community in identifying resistant organisms through surveillance and in reaching consensus on the need for new drugs. Data from the CDC's NNISS will be crucial to surveillance efforts and for developing guidelines for the rational use of antimicrobial drugs, as a means to delay the development of resistance. Should a global infectious disease surveillance system be put in place, such as the one suggested in this report, tracking antimicrobial resistance worldwide may be possible.

The development of public/private sector alliances, along the lines of the National Cooperative Drug Development Groups at the NIH (similar to the vaccine groups discussed above), may be desirable. There may also be circumstances similar to the current shortage of antituberculosis drugs in which the active involvement of the FDA may be necessary to encourage manufacturers to produce specific drugs or to pursue the development of drugs for a specific purpose.

The committee recommends that clinicians, the research and development community, and the U.S. government (Centers for Disease Control, Food and Drug Administration, U.S. Department of Agriculture,

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