Antimicrobial drug development - The past, the present, and the future

Clinical Microbiology and Infection, Supplement

Volumn 10, Issue 4, 2004, Pages 23-31

  Powers, J H ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Antimicrobial resistance; Clinical trials; Drug design; Drug development

Indexed keywords

AMINOGLYCOSIDE DERIVATIVE; ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; ANTIVIRUS AGENT; BETA LACTAM ANTIBIOTIC; CEPHALOSPORIN DERIVATIVE; CHLORAMPHENICOL; LINCOSAMIDE DERIVATIVE; MACROLIDE; NEW DRUG; OXAZOLIDINONE DERIVATIVE; PENICILLIN G; PLACEBO; POLYPEPTIDE ANTIBIOTIC AGENT; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RIFAMYCIN DERIVATIVE; STREPTOGRAMIN DERIVATIVE; SULFANILAMIDE; SULFONAMIDE; TETRACYCLINE DERIVATIVE; THALIDOMIDE; TRIMETHOPRIM;

ANTIBIOTIC RESISTANCE; ARTICLE; BACTERIAL INFECTION; BACTERIAL MENINGITIS; CLINICAL TRIAL; DRUG CLASSIFICATION; DRUG COST; DRUG FATALITY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG RESEARCH; ECONOMIC ASPECT; EPIDEMIC MENINGITIS; FOOD AND DRUG ADMINISTRATION; GRAM NEGATIVE BACTERIUM; HEALTH PROMOTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEPROSY; NONHUMAN; PRIORITY JOURNAL; PROFIT; PUBLIC HEALTH SERVICE; STANDARDIZATION; UNITED STATES; DRUG DESIGN; GENETICS; HISTORY; PHARMACEUTICS; REVIEW; SYNTHESIS; HISTORY OF MEDICINE; PUBLIC HEALTH;

ANTI-BACTERIAL AGENTS; CLINICAL TRIALS; DRUG DESIGN; DRUG RESISTANCE, BACTERIAL; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 16644367566     PISSN: 14709465     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1465-0691.2004.1007.x     Document Type: Article

References (21)

1. US Food and Drug Administration. Transcript of the FDA/IDSA/PhRMA workshop on antimicrobial drug development 2004: http://www.fda.gov/cder/present/idsaphrma/default.htm.
2. Schwentker FF, Gelman S, Long PH. The treatment of meningococcic meningitis. JAMA 1937; 108: 1407-8.
3. Temple RJ. Development of drug law, regulations, and guidance in the United States. In: Munson, PL, Mueller, RA, Breese, G, eds. Principles of Pharmacology Basic Concepts and Clinical Applications. Chapman & Hall, Boca Raton, FL, USA 1995, 1643-63.
4. Abraham EP. Cephalosporins 1945-86. In: Williams, JD, ed. The Cephalosporins. Auckland: Adis Press 1987, 1-14.
5. US Food and Drug Administration. Challenge and opportunity on the critical path to neuw medical products 2004: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.
6. Fox JL. Concerns raised over declining antiinfectives R & D. Nat Biotechnol 2003; 21: 12-55-6.
7. Hensley S. New antibiotic could boost besieged Aventis. The Wall Street Journal 2004; 4 March.
8. Thorpe KF, Florence CS, Joski P. Which mcclical conditions account for the rise in health care spending? Health Affairs 2004; 23, 25 August: W4-437-W4-445, http://content.healthaffairs.org/cgi/reprint/hlthaff.w437v1.
9. Mandell LA, Bartlett JG, Dowell SF, File TTv1 Jr, Musher DM, Whitney C. Update of practice guidelines for the management of community-acquired preumonia in immunocompetent adults. Clin Infect Dis 2003; 37: 1405-33.
10. Srinivasan A, Song X, Richards A, Sinkowitz-Cochran R, Cardo D, Rand C. A survey of knowledge, attitudes, and beliefs of house staff physicians from various specialties concerning antimicrobial use and resistance. Arch Intern Med 2004; 164: 1451-6.
11. Surowiecki J. The pipeline problem. The New Yorker, 2004: 16 February.
12. Infectious Diseases Society of America. Bad bugs, no drugs: as antibiotic discovery stagnates a public health crisis brews 2004: http://www.idsociety.org/pa/IDSA-Paper4_final_web.pdfRef Type: ElectronicCitation.
13. Shlaes DM, Moellering RC Jr. The United States Food and Drug Administration and the end of antibiotics. Clin Infect Dis 2002; 34: 420-2.
14. Powers JH, Ross DB, Brittain F, Albrecht R, Goldberger MJ. The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agents. Clin Infect Dis 2002; 34: 879-81.
15. Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2: 695-702.
16. DiMasi JA. Success rates for new drugs entering clinical testing in the United States. Clin Pharmacol Ther 1995; 58: 1-14.
17. Spellberg B, Powers JH, Brass EP, Miller LG, Edwards JF Jr. Trends in antimicrobial drug development: implications for the future. Clin Infect Dis 2004; 38: 1279-86.
18. US Food and Drug Administration. Transcript of the FDA/IDSA/ISAP worskshop or antimicrobial drug development 2004: http://www.fda.gov/cder/drug/antimicrobial/ FDA_IDSA_ISAP_Presentations.htm.
19. Interagency Task Force on Antimicrobial Resistance. Public health action plan to combat antimicrobial resistance 2004: http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf.
20. Powers JH. Development of drugs for antimicrobial-resistant pathogens. Curr Opin Infect Dis 2003; 16: 547-51.
21. US Food and Drug Administration. Transcript of the FDA Anti-Infective Drugs Advisory Committee meeting 2003: October 29; http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3997T2.pdf.