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Commentary

FDA policy reforms sorely needed to improve safety
Henry Miller, M.S., M.D., Detroit Free Press, 4-28-05

Another good article on drug safety. In this op-ed, Henry Miller makes the point that safety is a function of better data, not more bureaucrats.

The efficient detection of side effects is essential, and the United States needs to improve pharmaco-vigilance -- the monitoring of the safety of approved drugs. But the newly created FDA Drug Safety Oversight Board is not the answer. Rather than more bureaucrats, we must have better data. We need to encourage physicians' reporting of adverse events (perhaps by rewarding them with the Continuing Medical Education credits they need to retain licensure), to contract with organizations that treat large patient populations to monitor and report adverse events, and to share data with foreign regulators.


Project FDA.
  
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