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The Fast Track effect

Nature Reviews Drug Discovery volume 3, pages 293–294 (2004)Cite this article

The US FDA's Fast Track programme was designed to expedite drug development and approvals to address important unmet medical needs. There is now evidence, as delineated recently by the Tufts Center for Drug Development, that in this regard the programme has been a tremendous success, trimming total development time by nearly three years1. On the other hand, there is no language in the Fast Track provision to suggest that the FDA considers the likelihood of a programme's success when determining its suitability for Fast Track designation. However, many investors seem to believe that this is the case.

The Food and Drug Modernization Act of 1997 (FDAMA) codified existing FDA procedures and policies for facilitating drug development and expediting the approval of drugs that address serious or life-threatening unmet medical needs. A drug development programme (that is, a drug plus one specific indication) can be designated as Fast Track anytime after submission of an Investigational New Drug Application (IND), although sponsors potentially receive more benefits the earlier in development the designation is made.

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Figure 1
Figure 2: The Fast Track effect.
Figure 3

References

  1. FDA's Fast Track Initiative Cut Total Drug Development Time by Three Years, According to Tufts CSDD. Tuft's Center for the Study of Drug Development website [online] (cited 17.03.2004) <http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=34> (2003).

  2. All data on drug submission and approvals can be found on the FDA's web site at http://www.fda.gov.

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Authors and Affiliations

  1. President and Senior Analyst at independent healthcare research and consulting firm Crownstone, 3331 Street Road, Suite 140, Bensalem, Pennsylvania, USA

    Fredric J. Cohen M.D.

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  1. Fredric J. Cohen M.D.
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FURTHER INFORMATION

FDA Guidance Document for Fast Track Products

Section 112 of the Food and Drug Modernization Act of 1997

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Cohen, F. The Fast Track effect. Nat Rev Drug Discov 3, 293–294 (2004). https://doi.org/10.1038/nrd1349

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