Does a Drug Discovery Innovation Gap Really Exist?

Source: PharmaManufacturing.com

By Mike Lanthier

Aug 06, 2013

blogs.fda.gov

A new FDA study reports that innovative new drugs are reaching patients at a fairly constant rate.

The supposed innovation gap in drug discovery has generally been accepted as truth and a topic of deep angst for the pharmaceutical industry. However, if you take a hard look at the data, you’ll find it isn’t true. The way data is collected has been masking some important facts.

Conventional wisdom suggests that the pace of drug innovation should be measured by tallying the number of FDA-approved novel new medicines, known as new molecular entities (NMEs). When the number of NME approvals increases from year-to-year, media reports generally proclaim that drug innovation is on the rise; when the number dips, concerns are often raised about FDA’s drug review performance and the health of the industry as a whole. However, while the number of NME approvals in a given year provides something of value regarding the output of novel new drugs, this perennial focus on the quantity of drug approvals may not be sufficient to provide a meaningful measure of “innovation.” Read more
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