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Commentary

Is the FDA Broken?
Joseph Calfee, Ph.D., Tech Central Station, 4-30-05

Calfee takes issue with the premise that an independent drug safety board would help fix the “broken” FDA.

An independent drug safety board would make things worse precisely because it would be independent. Drug safety cannot be assessed separately from effectiveness. Even the best drugs have side effects…Information about both effectiveness and safety emerge in a continuous and highly unpredictable flow….Instead of an independent board, we need an organization that merges the safety and effectiveness information coming from clinical practice. That is exactly what the FDA is already trying to do on its own. This is one time when Congress should just let the FDA get on with its job.


Project FDA.
  
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