No news here. Many people expected 2005 to be a poor year for approvals. This quote is especially concerning:
"Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end," said Dr. Scott Gottlieb, the agency's [FDA] deputy commissioner for medical and scientific affairs.One of the implications for this is that many companies may find a more favorable regulatory environment outside the US. The presumption has always been that the US market is so huge, that dealing with the FDA process makes it worthwhile. Is this assumption still valid, especially with companies feeling the pressures from insurors on drug costs?
Drugs in '05: Much Promise, Little Payoff - New York Times
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