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A Gun-Shy FDA?

Executive Summary

FDA drug review times are up, and the number of approvals are down, with a wary investment community taking note and adding a new element to their earnings projections. The lack of a permanent FDA commissioner, understaffing, and the recent recalls/withdrawals of approved drugs are among the factors that may be leading to a slowdown. But whatever the significance of any shift in approval patterns over the last year or two, there are longer-term regulatory causes of concern for the drug industry--some attributable to the agency, but others stemming from the industry itself. With novel drugs taking up an increasing proportion of drug company pipelines, the FDA's staffing problems are compounded by having to evaluate therapies for which there are no reference points. The agency, having learned the hard way that it's extremely difficult to manage risk once a drug hits the market, will be particularly careful before passing on groundbreaking medications. And that tendency towards caution is only likely to become stronger as consumers become a powerful force in affecting prescribing patterns.

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