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News last week that the FDA is pushing ahead on the Critical Path Initiative offered some real hope for significant progress. Among the initiatives was an extremely promising effort to get the major drug companies to share early safety data. Anyone who follows drug development knows that the high level of attrition among drug candidates is a prime reason why the sticker price on new drugs keeps going higher. More insight into safety issues at an earlier stage can help improve attrition rates.

The more the FDA can foster efficiency, the greater the rewards. Sadly, this will all take years to play out. This isn't an industry that turns on a dime. As a result, we'll likely see headlines in a year or two saying that the Critical Path Initiative has failed to pan out as expected. But give it some time. The industry hasn't solved the problems posed by inefficiency. But it is pointed in the right direction. -John Carroll


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