Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Commentary
  • Published:

Moving goalposts—regulatory oversightof antibacterial drugs

Nature Biotechnology volume 24, pages 1519–1520 (2006)Cite this article

Fortunately, small biotech companies (some of which were spin-offs from the global pharmaceutical companies) have been able to attract the capital investment to continue the quest for new antimicrobial drugs. There is a small window during which discarded discovery research programs may be continued and result in meaningful new products. An early example was the development of Cubicin (daptomycin), which was discovered by Eli Lilly (Indianapolis, IN, USA) but developed and marketed by Cubist Pharmaceuticals (Lexington, MA, USA).

Ultimately, however, the big pharma pipeline of discarded programs will also dry up and it is unclear whether biotech will be capable of independently discovering novel antibiotic classes and bringing them to market. An unofficial tally of new chemical entities of antibacterials presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy meeting1 identified 27 from small biotech companies and only 13 from larger pharmaceuticals firms (most of which were from a single class, oxazolidinones). This is in contrast to the same meeting held in Toronto in 1997, where 63 new antibacterial drugs were in early or later phase development, almost all of which were big pharma products.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Meeting, September 27–30, 2006, San Francisco.

  2. Task Force on Antimicrobial Availability. Bad Bugs, No Drugs: As Antibiotic R&D Stagnates, a Public Health Crisis Brews (Infectious Diseases Society of America, Alexandria, VA, July 2004). <http://www.idsociety.org/pa/IDSA_Paper4_final_web.pdf>

  3. <http://www.fda.gov/cder/guidance/#clinical%20antimicrobial>

  4. European Medicines Agency/Committee for Proprietary Medicinal Products. Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (EMEA/CPMP, London, October 2004). <http://www.emea.eu.int/pdfs/human/ewp/055895en.pdf>

  5. US Food and Drug Administration/Center for Drug Evaluation and Research. Guidance for Industry for Special Protocol Assessment (FDA/CDER, Rockville, Maryland, 2002). <http://www.fda.gov/cder/guidance/3764fnl.htm>

  6. Anonymous. Nat. Rev. Drug Discovery 5, 446–447 (2006).

  7. Grassley, C. Letter to Andrew C. von Eschenbach, M.D. Acting Commissioner, Food and Drug Administration. (April 27, 2006). <http://www.finance.senate.gov/sitepages/grassley.htm>

  8. Dingell, J., Grassley, C., Markey, E., Waxman, H. & Stupak, B. Letter to David M. Walker, Comptroller General of the United States. (September 6, 2006). <http://markey.house.gov/docs/health/09-06-06%20Letter%20to%20GAO.pdf>

  9. US Food and Drug Administration. Points to Consider—Clinical Development and Labeling of Anti-infective Drug Products. (FDA, Rockville, Maryland, October 1992). <http://www.fda.gov/cder/guidance/ptc.htm>

  10. Blaser, M.J. & Bartlett, J.G. Letter to Acting Commissioner of Food and Drugs Administration. (September 28, 2006). <http://www.idsociety.org/Template.cfm?Section=Home&Template=/ContentManagement/ContentDisplay.cfm&ContentID=17039>

  11. Usdin, S. FDA's Superior Attitude. BioCentury 14, A7–A10 (September 18, 2006).

    Google Scholar 

  12. Usdin, S. Antibiotic resistance. BioCentury 14, A1–A6 (October 30, 2006).

    Google Scholar 

  13. US Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (US Department of Health and Human Services, Food and Drug Administration, Rockville, Maryland, February 2006). <http://www.fda.gov/Cder/guidance/5460dft.htm>

Download references

Author information

Authors and Affiliations

  1. Replidyne Inc., 1450 Infinite Drive, Louisville, 80027, Colorado, USA

    Roger Echols

Authors
  1. Roger Echols
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Echols, R. Moving goalposts—regulatory oversightof antibacterial drugs. Nat Biotechnol 24, 1519–1520 (2006). https://doi.org/10.1038/nbt1206-1519

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt1206-1519

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing