The numbers are in for 2013.  During the past year the US Food and Drug Administration approved 27 new drugs.  This compares with a record 39 approvals for 2012 and 30 for 2011.  But what does this mean?  What’s in store for 2014?

Before discussing the numbers and the possible trends, I want to make sure we are all on the same page.  The drug approval data is based on what the FDA classifies as New Molecular Entities (“NMEs”) and includes both traditional small organic molecule drugs as well as biological products.  Also, the definition for NME is broader than the FDA’s definition of a New Chemical Entity (“NCE”), which refers to a drug that has not been previously approved or marketed in the US.  For example, an NME can comprise a combination product containing a previously approved NCE.

On the one hand, the FDA is optimistic about the trends from the 2013 numbers.  The Agency reports that the “27 NMEs approved in calendar year 2013 is similar to the average totals approved in the past decade”.[1]  The Agency also reports that from 2004 through 2012, CDER averaged 26 approvals per year and that the 39 approvals seen in 2012 “was an unusually high number”.[2]  However, others are less complimentary and have cited higher development costs, lower rates of return on these costs, and lower peak sales, as possible causes for the less than stellar performance of 2013.[3]

My take on all this is that one cannot readily read a trend into 2014.  If anything, the more pertinent information from the FDA is that the number of new drug applications has not been consistently and significantly increasing.  The Agency reports that from 2004 through 2012 an average of 34 applications for NMEs have been filed per year.  Even in 2012, which gave us 39 approvals, these approvals were based on just 41 applications – the same number of applications as received in 2011.[4]  If the number of new drug applications continues to remain relatively static, it is not likely that there will be a significant uptick in 2014 approvals.  Let’s hope this is not the case, but we won’t know until this time next year.

By Anthony D. Sabatelli, PhD, JD
Dilworth IP




[4]Ibid., footnote 1.

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