Tuesday, October 29, 2013

FDA Bad Ads: A few key pieces of information


Prescription drug advertising must:
  • Be accurate
  • Balance the risk and benefit information
  • Be consistent with the prescribing information approved by FDA
  • Only include information that is supported by strong evidence
What types of promotion does OPDP regulate?
  • TV and radio advertisements
  • All written or printed prescription drug promotional materials
  • Speaker program presentations
  • Sales representative presentations 
OPDP does not regulate promotion of:
  • Over-the-Counter Drugs
  • Dietary Supplements
  • Medical Devices
Common Violations:
  • Omitting or downplaying of risk
  • Overstating the effectiveness
  • Promoting Uses Not Addressed in Approved Labeling 
  • Misleading drug comparisons 
quoted from here

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