In 2013, the FDA approved only 27 new drugs instead of the banner 39 seen in 2012. Some commentators have taken this to be a harbinger of bad things to come. Are Big Pharma R&D departments still broken as opposed to being on the mend after last year's good totals came through? I suspect that it is impossible to say based on only 2 year's data. I tend to put more stock in the 5 year or 10 year trend. Otherwise there seems to be too much variance in approvals just based on timing issues within the FDA.
By the way, I never bought into the premise that last year's approvals heralded the end of pharma R&D department woes either. I think that interpretation is equally erroneous. I mean look a all the drugs just that FDA have recently designated for "breakthrough status" -- 37 at last count. Shouldn't a higher percentage of these reach the market sooner. Would this mean R&D has gotten lots better? Perhaps some in that novel compounds were under review -- but it also obviously would reflect faster review by FDA. And the exact timing of this is going to affect the "approval number" for any given calendar year. So let's hold off a bit on hard interpretations until we have a few years' data to look at. See Fierce Biotech and In the Pipeline.
Canary in a coal mine? More like crumbs in the toaster set off the smoke alarm.
Posted by Bruce Lehr Jan 6th 2014.