Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Oct;2(4):307-13.
doi: 10.4103/0975-7406.72130.

Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies

Rajiv Mahajan  1 , Kapil Gupta
Affiliations

Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies

Rajiv Mahajan et al. J Pharm Bioallied Sci. 2010 Oct.

Abstract

During the last decade, despite increased investment in drug research and development related activity, stagnation in new drug discovery has been documented. Despite a 70% increase in investment in research and development-related activities, a 40% fall in launch of new chemical entities was seen during 1994-2004. A steep rise in the attrition rate of drug development has complicated the matter. Rising cost and increased attrition rates proved major barriers to investment in higher risk drugs or in therapies for uncommon diseases or diseases that predominantly afflict the poor. This prompted Food and Drug Administration (FDA) to highlight this problem in a 2004 white paper classified as "Critical Path Initiative" (CPI) and to initiate steps to target stagnation and rise in attrition rates. Many new drug development projects have started worldwide taking cue from CPI; adopting microdosing, adaptive designs and taking advantage of newly developed biomarkers under the CPI. This review discusses the various strategies adopted under CPI to decrease attrition rate and stagnation of new drug development, and the challenges and controversies associated with CPI.

Keywords: Biomarkers; clinical trials; drug development; microdosing.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Comparison between R and D investment and NMEs launched between 1994 and 2004[15]
Figure 2
Figure 2
Comparative investment on new successful drug launch between 1995–2000 and 2000”2002[4]
See this image and copyright information in PMC

References

    1. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ. 2003;22:151–85. - PubMed
    1. Adams CP, Brantner VV. Spending on new drug development. Health Econ. 2010;19:130–41. - PubMed
    1. Oates JA. The science of drug therapy. In: Brunton LL, Lazo JS, Parker KL, editors. Goodman and Gilman’s The pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill; 2006. p. 134.
    1. Innovation or Stagnation: Challenge and opportunity on the critical path to new medical products. Washington DC, USA: Food and Drug Administration; 2004. Food and Drug Administration.
    1. Berkowitz BA. Development and Regulation of Drugs. In: Katzung BG, Masters SB, Trevor AJ, editors. Basic and Clinical Pharmacology. 11th ed. New Delhi: Tata McGraw Hill; 2009. p. 67.