The FDA reboot of antibiotic development

Antimicrobial Agents and Chemotherapy

Volumn 57, Issue 10, 2013, Pages 4605-4607

  Shlaes, David M ^a   Sahm, Dan ^b   Opiela, Carol ^b   Spellberg, Brad ^c  

^a Anti Infectives Consulting   (United States)

^b Eurofins Medinet Inc   (Germany)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; CARBAPENEM DERIVATIVE; CEPHALOSPORIN DERIVATIVE; PLACEBO; SULFONAMIDE; TELITHROMYCIN;

ABDOMINAL INFECTION; ACINETOBACTER BAUMANNII; BACTERIAL PNEUMONIA; ESCHERICHIA COLI; GEOGRAPHY; HUMAN; INTENSIVE CARE UNIT; KLEBSIELLA PNEUMONIAE; LIVER TOXICITY; NOTE; PNEUMONIA; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; SKIN INFECTION; UNITED STATES; URINARY TRACT INFECTION; WORKSHOP;

ANTI-BACTERIAL AGENTS; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84884216913     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01277-13     Document Type: Note

References (22)

1. Spellberg B, Brass EP, Bradley JS, Lewis R, Shlaes D, Ambrose P, Das A, Boucher HW, Doi Y, Bartlett JG, Bonomo RA, Larosa SP, Talbot GH, Benjamin D, Guidos RJ, Jezek A, Gilbert DN, on behalf of the Infectious Diseases Society of America. 2012. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drugresistant bacterial pathogens. Clin. Infect. Dis. 55:1031-1046.
2. Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, Friedland I, Knirsch C, Sanhai WR, Tomayko J, Lancaster C, Jackson J. 2013. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect. Dis. 13:269-275.
3. Shlaes DM, Moellering RC, Jr. 2002. The United States Food and Drug Administration and the end of antibiotics. Clin. Infect. Dis. 34:420-422.
4. Projan SJ, Shlaes DM. 2004. Antibacterial drug discovery: is it all downhill from here? Clin. Microbiol. Infect. 10(Suppl 4):18-22.
5. Sharma P, Towse A. 2011. New drugs to tackle antimicrobial resistance: analysis of EU policy options. Office of Health Economics, London, United Kingdom. http://www.ohe.org/publications/article/new-drugs-to-tackle- antimicrobial-resistance-5.cfm.
6. Spellberg B, Sharma P, Rex JH. 2012. The critical impact of time discounting on economic incentives to overcome the antibiotic market failure. Nat. Rev. Drug Discov. 11:168. doi:10.1038/nrd3560-c1.
7. Temple R, Ellenberg SS. 2000. Placebo-controlled trials and activecontrol trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann. Intern. Med. 133:455-463.
8. Spellberg B. 2010. The antibacterial pipeline: why is it drying up and what must be done about it?, p 299-332. In Choffnes ER, Relman DA, Mack A (ed), Antibiotic resistance: implications for global health and novel intervention strategies. Workshop Summary. Institute of Medicine of the National Academies. National Academies Press, Washington, DC.
9. Echols R. 2012. A long and winding road; evolution of antimicrobial drug development-crisis management. Expert Rev. Anti Infect. Ther. 10:1311-1318.
10. Shlaes DM, Moellering RC, Jr. 2008. Telithromycin and the FDA: implications for the future. Lancet Infect. Dis. 8:83-85.
11. Food and Drug Administration. 2009. Guidance for industry. Community-acquired bacterial pneumonia: developing drugs for treatment. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services, Silver Spring, Maryland. htt p://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInf ormation/Guidances/UCM123686. pdf.
12. Food and Drug Administration. 2010. Guidance for industry. Hospitalacquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services, Silver Spring, Maryland. http://www.fda.gov/download s/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM 234907.pdf.
13. Shlaes, DM. 2010. Antibiotics: the perfect storm, p 29-50. Springer-Verlag, New York, NY.
14. Food and Drug Administration. 2010. Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services, Silver Spring, Maryland. http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/UCM071185.pdf.
15. Spellberg B. 2011. Acute bacterial skin and skin structure trials: the bad is the enemy of the good. Clin. Infect. Dis. 53:1308-1309.
16. Snodgrass WR, Anderson T. 1937. Prontosil in the treatment of erysipelas. A controlled series of 312 cases. BMJ 2:101-104.
17. Snodgrass WR, Anderson T. 1937. Sulphanilamide in the treatment of erysipelas: a controlled series of 270 cases. BMJ 2:1156-1159.
18. Cooper M, Shlaes DM. 2011. Fix the antibiotic pipeline. Nature 472:32.
19. Centers for Disease Control and Prevention. 2013. Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb. Mortal. Wkly. Rep. 62:165-170.
20. Hidron AI, Edwards JR, Patel J, Horan TC, Sievert DM, Pollock DA, Fridkin SK; National Healthcare Safety Network Team. 2008. NHSN annual update: antimicrobial-resistant pathogens associated with healthcare-associated infections: annual summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2006-2007. Infect. Control Hosp. Epidemiol. 29:996-1011.
21. Spellberg B, Bartlett JG, Gilbert DN. 2013. The future of antibiotics and resistance. N. Engl. J. Med. 368:299-302.
22. Food and Drug Administration. 2013. Guidance for industry. Antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health andHumanServices, Silver Spring, Maryland. http://www.fda.gov/downloads/Drugs/Guidanc eComplianceRegulatoryInformation/Guidances/UCM359184.pdf.