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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