Science & Technology: Innovation Deficiency: Decreasing NMEs in the Drug Discovery Pipeline

Posted 01 May 2009 | By

With recent scientific advances coupled with the advent of new technologies, one would expect a boom in new drug development. However, current facts tell us a completely different story. Except in 2008, when the pharmaceutical industry had some relief due to marginal increases in US Food and Drug Administration (FDA) approvals, the drug pipeline has shown a significant downturn over the past two decades. In 2007, FDA approved 19 new drugs, the fewest in 24 years, and announced approximately 75 new or revised Black Box warnings, which was twice the number in 2004.1 This runs contrary to pharmaceutical research spending, which has reached more than $58 billion per year (Figure 1).2 So where are the new drugs? Why are they not coming to market? Who is responsible for this situation? This article discusses the major issues and challenges responsible for this diminishing new drug pipeline.

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