Risk Information in Prescription Drug & Medical Device Ads, Promotional Labeling – What the FDA Expects
The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.
The guidance document discusses the factors relevant to the disclosure of risk information and provides numerous examples to illustrate the FDA recommendations.
Applicability
The guidance applies to promotional materials for drugs and devices and advertisements for prescription drugs and restricted devices directed at both consumers and healthcare professionals.
Regulatory requirements
The Food, Drug and Cosmetic Act and the FDA’s regulations state that promotional material are deemed misleading if they fail to disclose certain information about the product’s risks. In order to comply with these regulations, the promotional material:
- Cannot be false or misleading in any particular
- Must reveal material facts about the product, including facts about the consequences of using the product as suggested in the promotional material
- Should present information about effectiveness and information about risk in a balanced manner
Summary of factors considered by FDA during review of risk communication
The FDA takes the following factors into consideration when reviewing the risk communication included by manufacturers in promotional materials:
General Considerations:
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Consistent Use of Language Appropriate for Target Audience
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Use of Signals
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Framing Risk Information
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Hierarchy of Risk Information
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Considerations of Content
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Quantity
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Benefit and risk information should be proportionately presented. FDA evaluates the following:
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Materiality and Comprehensiveness
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Consideration of Target Audience
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Consumer-directed communications should convey:
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Importance of Package Insert
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The Nature of Benefit Claims
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Accuracy and Comprehensiveness of Risk Information
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Need a better understanding of regulations governing the advertisement/ promotion of drugs and medical devices? Attend any of the following ComplianceOnline webinars:
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Considerations of Format
The FDA considers formatting factors when assessing whether a piece is false or misleading. Format includes the shape, size, and general layout of all portions of a print promotional piece, as well as the general plan of organization, arrangement, and theme in non-print promotional pieces such as videos and broadcast ads.
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Print Promotion
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Non-Print Promotion
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Additional Resources:
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