Impact of antibiotic restrictions: The pharmaceutical perspective

Clinical Microbiology and Infection

Volumn 12, Issue SUPPL. 5, 2006, Pages 25-34

  Power, Eddie ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Antibiotic resistance; Pharmaceutical development; Pharmaceutical regulation; Rational antibiotic prescribing; Review

Indexed keywords

ANTIBIOTIC AGENT; CEFDITOREN PIVOXIL; DALFOPRISTIN PLUS QUINUPRISTIN; DAPTOMYCIN; ERTAPENEM; GATIFLOXACIN; GEMIFLOXACIN; GENERIC DRUG; LINEZOLID; MOXIFLOXACIN; ORPHAN DRUG; RIFAXIMIN; TELITHROMYCIN; TIGECYCLINE;

ANTIBIOTIC RESISTANCE; BACTERIAL INFECTION; BUDGET; DECISION MAKING; DRUG APPROVAL; DRUG DETERMINATION; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; DRUG USE; ECONOMIC ASPECT; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; INVESTMENT; PATENT; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; UNITED STATES;

EID: 33745284562     PISSN: 1198743X     EISSN: 14690691     Source Type: Journal    
DOI: 10.1111/j.1469-0691.2006.01528.x     Document Type: Review

References (17)

1. Monnet DL. Antibiotic development and the changing role of the pharmaceutical industry. The global threat of antibiotic resistance. A multidisciplinary meeting at the Dag Hammarskjöld Foundation. Uppsala, Sweden, May 5-7, 2004. Available at: http://www.dhf.uu.se/antibiotics_participant/new_pdf/Industry.pdf [Published: 2004; accessed: 12 August 2005].
2. Tufts Center for the Study of Drug Development. Tufts Center for the Study of Drug Development pegs cost of a new prescription medicine at $802 million. Available at: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6 [Published: 2001; accessed: 3 August 2005].
3. Forbes.com. Lilly's blockbuster peril. Available at: http://www.forbes.com/2002/04/30/0430lilly_print.html. [Published: 2002; accessed: 12 August 2005].
4. Boston Consulting Group. A revolution in R&D. How genomics and genetics will affect drug development costs and times. In: Pharmaceutical R&D Statistical Sourcebook 2002/2003. Waltham MA: Parexel, 2002.
5. Tufts Center for the Study of Drug Development. Outlook 2005. Available at: http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2005.pdf [Published: 2005; accessed: 3 August 2005].
6. US Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. Available at: http://www.fda.gov/ oc/initiatives/criticalpath/whitepaper.html [Published: 2004; accessed: 12 August 2005].
7. Coghlan A. Blockbuster challenge. New Scientist 2004 Available at: http://www.newscientistjobs.com.au/insider/ article.action?article.id=insider105&focusId=uk [accessed: 12 August 2005].
8. Blau G, Mehta B, Bose S et al. Risk management in the development of new products in highly regulated industries. Comp Chem Eng 2000; 24: 659-664.
9. Bartlett JG. Why is big pharma getting out of anti-infective drug discovery? Available at: http://www.medscape.com/viewarticle/461620 [Published: 2003; accessed: 12 August 2005].
10. US Food and Drug Administration DoA-IDP. Points to consider: Clinical development and labeling of anti-infective drug products. Available at: http://www.fda.gov/cder/guidance/ptc.htm [Published: 1992; accessed: 3 August 2005].
11. Shlaes DM, Moellering RC Jr. The United States Food and Drug Administration and the end of antibiotics. Clin Infect Dis 2002; 34: 420-422.
12. Gilbert DN, Edwards JE Jr. Is there hope for the prevention of future antimicrobial shortages? Clin Infect Dis 2002; 35: 215-216; author reply 216-217.
13. Bauraind I, Lopez-Lozano JM, Beyaert A et al. Association between antibiotic sales and public campaigns for their appropriate use. J Am Med Assoc 2004; 292: 2468-2470.
14. US Food and Drug Administration. CDER drug and biologic approval reports. Available at: http://www.fda.gov/cder/rdmt/ [accessed: 12 August 2005].
15. World Health Organization. Rare essentials? Drugs for rare diseases on the Essential Medicines List. Available at: http://www.who.int/medicines/organization/par/edl/expcom14/1other/ Rare_diseases_finalMarch1_2005.pdf [Published: 2005; accessed: 12 August 2005].
16. Harbarth S, Samore MH. Antimicrobial resistance determinants and future control. Emerg Infect Dis 2005; 11: 794-801.
17. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ 2003; 22: 151-185.