Rules

Rx drug ad: effectiveness claims must be balanced by comparable risk information (502(n))

Repeated effectiveness claims in the risk section may dilute required side-effect emphasis

Prescription-drug ad may lack fair balance if side-effect prominence trails efficacy

Facing pages must be clearly marked as one continuous advertisement

Ads targeting a selected patient class may lack fair balance if class-specific risks/dosage are not adequately emphasized

Ad may be misleading if a page/spread lacks risk info or prominent locator reference

Disclose unfavorable or inconsistent findings, not just favorable results

Include related FDA-required labeling data for context when presenting related new information

Include representative publications reaching contrary conclusions when a source's conclusions are disputed

Risk information should increase as benefit information increases

Treat risk information comparably to benefit information throughout

Include risk information in the main part of the piece

Present risk information in the same parts of the piece as benefits

Complete separation of benefit and risk information lacks appropriate prominence

Make risk information comparably noticeable as benefit information

FDA may object to substantially smaller font for risk information

Use similar type styles for risk and benefit information

Do not give benefit information greater contrast than risk information

Make risk information comparably readable as benefit information

FDA may object to risk information in a difficult-to-read font size