How many new drugs does the FDA approve?

Recently a question was floated on Twitter as to how many drug approvals the FDA has done. Quickly a few answers came in where it heavily depends on what one counts as a ‘new drug’, is a registered generic molecule also a new drug or is this not innovative enough?

For the sake of doing statistics on these numbers I’ve extracted the datapoints of a few data resources. First from the FDA itself, they have a funky table showing the number of new drug application (NDA) approved, received and the number of new molecular entities. I’ve extracted the data and plotted this below from 1944-2011 and can be downloaded here.

FDA NDA Approvals & Receipts from 1944-2011 (data)

Another interesting categorisation is the source of the molecules. In 2009 John Vederas published a highly cited article on the origin of the FDA approved drugs between 1981 -2007. Unfortunately the raw data behind this plot is not available so I’ve interpolated the numbers from this article figure and plotted the data below, again can be downloaded here. It is pretty clear that the number of natural (derived) molecules is declining.

 Number of drugs approved in the US split up by source from 1981 to 2007 interpolated from Vederas et al. (data)

feature in Drug Discovery Today  by Kinch et al. shows extensive analysis of new molecular entities as well as the ones one paid for the R&D. As a commenter notes on PubMed Commons it is too bad the underlying data is not available. Therefor the graph shown below is an interpolation of their figure.

Number of new molecular entities (NME) approved by the FDA from  1930-2013  interpolated from Kinch et al. (data)

A quick comparison shows that the FDA NME numbers and the numbers by Kinch et al. are in the same ballpark, deviations can be due to my interpolation or a difference in counting NMEs, for example Kinch et al. are  “excluding imaging and diagnostic agents.

Comparison of new molecular entities as reported by the FDA and  Kinch et al. 

If anyone has a more comprehensive article or publicly available numbers that would greatly be appreciated.


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