Food and Drug Administration

Anti-Infective Drugs Advisory Committee

February 20, 2002
Discussion Topic: Approaches to the development of antimicrobial agents for the treatment of resistant pathogens

Briefing Information

Developing Drugs for Resistant Pathogens, CDER, FDA   pdf   doc

Appended References and Selected Readings

  1. A Public Health Action Plan to Combat Antimicrobial Resistance Part 1: Domestic Issues. Interagency Task Force on Antimicrobial Resistance. Source:

  2. Bax RP. Antibiotic resistance: a view from the pharmaceutical industry. Clin Infect Dis 1997; Jan; 24 Suppl 1:S151-3.

  3. Billstein SA. How the pharmaceutical industry brings an antibiotic drug to market in the United States. Antimicrob Agents Chemother 1994 Dec;38(12):2679-82.

  4. Cohen M. Epidemiology of drug resistance: implications for a post-antimicrobial era. Science 1992 Aug 21;257(5073):1050-5.

  5. Georgopapadakou NH. Infectious disease 2000: drug resistance and new drugs.  Drug Resist Updat 2000 Oct;3(5):265-269.

  6. Hancock RE. The role of fundamental research and biotechnology in finding solutions to the global problem of antibiotic resistance. Clin Infect Dis 1997 Jan;24 Suppl 1:S148-50.

  7.  House of Lords, Science and Technology - Seventh Report. Chapter 6, New drug development. Source:

  8. Moellering RC Jr. Antibiotic resistance: lessons for the future. Clin Infect Dis 1998 Aug;27 Suppl 1:S135-40; discussion S141-2.

  9. Silver LL, Bostian KA. Discovery and development of new antibiotics: the problem of antibiotic resistance. Antimicrob Agents Chemother 1993 Mar;37(3):377-83.

  10. Tenover FC. Development and spread of bacterial resistance to antimicrobial agents: an overview. Clin Infect Dis 2001 Sep 15;33 Suppl 3:S108-15.

  11. Williams RJ. Globalization of antimicrobial resistance: epidemiological challenges. Clin Infect Dis 2001 Sep 15;33 Suppl 3:S116-7.

  12. Walsh C. Molecular mechanisms that confer antibacterial drug resistance. Nature 2000 Aug 17;406(6797):775-81.

  13. Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med 2000 Dec 28;343(26):1917-24.