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Commentary

The burden of staying alive; It's the drugs you can't get that might kill you
Dr. Scott Gottlieb, Chicago Tribune, 1-21-05

Gottlieb points out (from personal experience) that the FDA is a punching bag for a small army of interests who gain from portraying the agency as a hapless lackey of big pharmaceutical companies.

The result? Every time the FDA is accused of moving too fast, it suddenly shifts into tortoise mode - across the board, including for new cancer treatments. Gottlieb says that a “new policy promulgated by the FDA will effectively raise the bar for approving new cancer drugs, meaning cancer medicines may take many more years to come to market, if they make it at all.”

The lesson learned: while agency critics may applaud a slower FDA, patients will die waiting for it to speed up again.



Project FDA.
  
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