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US Food and Drug Administration: out50 en

US Food and Drug Administration: out50 en

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Published by: FDA on Jan 19, 2008
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05/24/2012

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No antibacterials with novel modes of action have been introduced in the last
decade (Shlaes, 1993) though there are several currently in clinical
development – e.g. oxazolidinones and everninomycins. Firstly, it is
difficult to find or create truly novel agents which are patentable. Secondly,
there may be a finite number of appropriate targets in bacteria. Thirdly, it is
commercially unattractive to invest in research having little chance of
producing a return. The cost of research, development and testing of a novel
antimicrobial is now probably in excess of US$350 million (Gold, 1996),
and the time required for effective marketing is at least 6-7 years (Cohen,
1992; Billstein, 1994). As a result, the number of companies investing in
antibacterial research declined even before the recent trend towards company
mergers occurred. Moreover,there is the risk that a costly new antimicrobial
drug may well become obsolete within a few years, reducing the economic
returns that can be expected to a level that is insufficient to justify the
investment (Goldmann, 1996).

However, the rapidly expanding phenomenon of antimicrobial resistance has
begun to stimulate industry interest. In particular, the wealth of information
derived from bacterial genetics has opened new avenues for the development
of antimicrobials with novel mechanisms of action which may also be less
susceptible to known mechanisms of antimicrobial resistance. Collaboration
between the academic institutions, WHO, national public health bodies and
the drug industry has already been useful in the war against bacterial
resistance (Heymann, 1996). Encouragement should be given for the
development of truly novel antibacterials and also for clinical trials to
establish optimal treatment regimens for defined clinical conditions.

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Inevitably, bacteria will eventually develop resistance to new agents,
although this may take a long time. Therefore, efforts are needed to protect
the utility of novel agents by establishing more carefully the principles of
prudent use.

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