Abstract
Pharmaceutical industry doomsayers have been licking their chops for months watching the roster of drug approvals for 2016 limp to a weak total of 22, following a record of 45 approvals in 2015. The roughly 50% drop comes after five years of generally increasing Food & Drug Administration approvals. Seeing the low numbers coming, industry watchers have been waxing leery regarding a possible industry downturn. Questions about whether drug companies will be able to adequately fund investment in R&D were sharpened by this year’s disappointing approval tally. Industry analysts, however, say the downturn is normal. “You always have to expect some cyclicality both in the submissions and the number of drugs approved,” says Jon Lange, head of Ernst & Young’s life sciences R&D division. Lange acknowledges that the drop, in part, reflects the increasing difficulty that drugmakers experience in hitting the mark in tough areas such as Alzheimer’s disease and
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