Risk Information in Prescription Drug & Medical Device Ads, Promotional Labeling – What the FDA Expects

  • By: Staff Editor
  • Date: November 18, 2011
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The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices.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.
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:
Consistent Use of Language Appropriate for Target Audience
  • Promotional materials directed at professionals can reasonably describe benefits and risks in medical language
  • Material directed at consumers should convey benefits and risks in a language understandable to consumers
Use of Signals
  • Signals are headlines or sub-heads
  • Should be consistent across risk and benefit information
  • Not using signals can minimize risks and mislead audience
Framing Risk Information
  • Risk information should be presented in the same terms or with the same degree of specificity as benefit information.
  • Risk information framed in a way that minimizes the severity of a risk event may also cause a promotional piece to be considered false or misleading.
  • Risks should be presented in a way that accurately reflects their nature
Hierarchy of Risk Information
  • Most important risk information, including relevant warnings and contraindications, be placed or stated first, especially in print materials.
  • Risk information should not just be presented in one location in the promotional material, but should, like benefit information, appear as an integral part of the ad or label.
Considerations of Content
Benefit and risk information should be proportionately presented. FDA evaluates the following:
  • Number of statements about benefits and risks
  • Completeness and depth of detail about risks and benefits
  •  Amount of time devoted to risks and benefits in video, audio or broadcast communication
  •  Amount of space devoted to benefits and risks in print communication
  • Use of audio or visuals that distract from presentation of benefit and risk information
Materiality and Comprehensiveness
  • Materiality is determined by the degree to which information is objectively important, relevant, or substantial to the target audience
  • Material facts help enhance understanding of
    • Relevant product properties
    • Whether or not product is appropriate for medical practitioners or their patients
    • Whether or not they are willing to accept risks or burdens of the product
Consideration of Target Audience
Consumer-directed communications should convey:
  • Use of drug of device
  • Who should or should not take the drug or use a device
  • What can be expected from the drug or device
  • What patients should ask their healthcare professionals about a drug or device
  • What patients should tell their healthcare professionals about before or while taking a drug or using a device
Importance of Package Insert
  • For prescription drugs, should include:
    • Boxed warning
    • Contraindications
    • Warnings and precautions
    • Adverse reactions
    • Drug interactions
    • Use in specific populations
    • Drug abuse & dependence
    • Overdosage
The Nature of Benefit Claims
  • Should reveal risk information that is material in light of the specific benefit claims
Accuracy and Comprehensiveness of Risk Information
  • All significant risks should be included as the FDA evaluates the quality of information used in promotional material
Need a better understanding of regulations governing the advertisement/ promotion of drugs and medical devices? Attend any of the following ComplianceOnline webinars:
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.
Print Promotion
  • Overall location of risk information: Risk information should be included in the main part of a piece
  • Location of risk information within the promotional material: Risk information should be an integral part of the material, just like benefit information
  • Font size and style: Risk and benefit information should be presented in similar type styles
  • Contrast: Contrast between text and background should not highlight benefits more than risks
  • White space: Benefits and risks should be presented in a similar with respect to line and paragraph spacing, bullet point and other attention getting methods
Non-Print Promotion
  • Textual information: Risk related SUPERs used in broadcast video/ ads should be visible and readable to the audience and not be compromised by graphics that distract from risk information
  • Contrast: Risk related SUPERs should be presented in a font color that contrasts reasonably with the background color/ graphics
  • Dual mode considerations: The visuals in an ad should not distract from audio that relates risk information
  • Audio considerations: Quality of audio used to convey risk and benefits should be the same
Additional Resources:
Read the FDA draft guidance on presenting risk information in prescription drug medical device promotional material in full



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