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Commentary

Medicating the FDA
Henry Miller, M.S., M.D., Washington Times, 2-17-05

Miller takes stock of the U.S. drug development and FDA approval process, and notes that more needs to be done to identify adverse drug events (ADEs) and improve patient safety - provided we don’t keep valuable medicines away from patients and doctors.

“The efficient detection of ADEs is essential, and the United States needs improved pharamcovigilance…This should be done not by creating a new, independent agency, but by fixing the FDA. However, it is questionable if the newly announced FDA Drug Safety Oversight Board…is the answer.”

Miller concludes that “we need better data rather than more bureaucrats”, and that, ultimately, “public health is more imperiled by lack of drugs in the development pipeline..than by side effects from approved drugs…we must make sure that the cure [for drug safety] isn’t worse than the disease.”



Project FDA.
  
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