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Lower Numbers, Novelty, and Economic Impact Indicate Problems
Ronald A. Rader

FDA pharmaceutical approvals in recent years, particularly in 2007, have noticeably decreased. Typically, coverage of declining FDA approvals has concentrated on pharmaceuticals in general or those regulated as drugs. This article reviews 2006 and 2007 approvals of new biopharmaceutical treatments and notes some disturbing trends. These include fewer drugs given the green light in recent years and particularly in 2007, a lower level of novelty as well as healthcare and economic impact. 

If the low number of approvals, their novelty, and their impact remain at last year’s levels, the industry is in big trouble. It remains unclear who, if anyone, deserves the blame. There is hope for a turnaround in the near future, however, as we appear to be near the end of or coming out of a low period.