Blog 5 Help-Seeking and other Disease Awareness Communications

Name of the Guidance:
“Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
Status of the Guidance:
Draft guidance published in January 2004
When the Guidance was Released:
January 2004
Link to the Guidance:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070068.pdf
Target Audience:
Sponsors of prescriptions drugs and medical devices and medical communication companies working on behalf of sponsors to develop disease awareness communications directed to consumers.
Laws and Regulations Referenced:
21 CFR Part 202.1 – Prescription Drug Advertisement regulations
21 CFR 314.50 FDA-approved labeling for drugs
21 CFR 601.2 FDA-approved labeling for biologics
21 CFR 814.2 FDA-approved labeling for devices
Summary:
Disease awareness communications include general discussions of a disease or health condition, communications that advise the target audience to “see your doctor” for diagnosis or treatment, advisements to doctors and health professionals to encourage awareness signs of a disease, or information on diagnosis of a particular disease. Disease awareness communications cannot name, suggest, or represent any particular drug or device. The FDA encourages industry-sponsored disease awareness communications because these types of communications do promote the general public health and are often sponsored and disseminated by government agencies and educational organizations. However, when sponsored by manufacturers of a drug or device, these guidelines should be followed to ensure the help-seeking communications do not go beyond the limits of help-seeking or disease awareness communications and become advertisements or promotional material for a specific drug or device.

It is the FDA’s position that most disease awareness communications are not labeling or advertising so there is no need for disclosure of risk information. This assessment does not necessarily apply to companies who are the only manufacturer of a commercially available product for a particular disease or condition or companies who manufacture only one commercially available product. Such companies are not necessarily excluded from disseminating help-seeking information; however, if the through the help-seeking communication a particular drug or device is implicated then the FDA may treat the communication as advertisement and require the disclosure of risk information. For communications that combine help-seeking communication and reminder advertisement, an advertisement that may mention a product and advice to see a physician, the disclosure of risk information is required or the product may be deemed to be misbranded.
The guidance also recognizes that when the timing and proximity of promotional material is close to the help-seeking communications the help-seeking communication may be mentally linked with the product being promoted. The audience may perceive the two components as one and the message will be linked.
Rationale:
The primary purpose of the guidance is to help clarify for sponsors the distinction of help-seeking and disease awareness communications and promotional advertisements for regulated products. Sometimes the combination of two communications, neither of which alone would be considered promotional, may together meet the definition of an advertisement and have to comply with the FDA regulations for advertisements of prescriptions drugs. Sponsors must ensure the help-seeking and disease awareness material are perceptually distinct in content, in timing of display or in physical proximity so there will not be a psychological link to a disease and product.
Resulting Recommendations:
The FDA recommends that sponsors consider the following factors when developing help-seeking or disease awareness communications that would be exempt from the mandated risk disclosure for promotional material for prescription drugs:
• Are the pieces perceptually distinct in use of graphic, visual, thematic, or other presentation elements?
• Are the pieces presented in close physical or temporal proximity?
Impact:
This guidance will assist sponsors in developing and planning disease awareness or help-seeking campaigns that are designed to promote use of their drug or device without violating the FDA’s regulations on the promotion of drugs and devices.