The Approval Drought Continues
This article was originally published in RPM Report
No matter how you look at the numbers, it was another bad year for new product launches in the US. FDA approved more new drugs than last year, but just barely. And the number of products going off-patent actually exceeded the number of new launches. The sparse crop of new drugs this decade means lean years ahead for the pharma industry.
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New molecular entity approvals dipped in 2010 and Innovative Commercial Therapies dropped even more sharply. Add to that a significant drop in filings in 2010 and it is hard to be optimistic about a turnaround in approval numbers any time soon.
By FDA's count, novel drug approvals were up more than 30% in 2008, to a respectable 24. Unfortunately, the number of Innovative Commercial Therapies was no better than it has been for the past four years. But it could have been worse.
You have to go back to 1983 to find a year as bad as 2007 for R&D output. It was a terrible year by any measure. The key question for industry: does it need to learn to subsist on a trickle of new drugs coming to market each year, or is the current drought in fact a sign of a transition to a new, more innovative R&D model? The sparse class of 2007 does offer some glimmers of hope.