Help-seeking ads are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.
These communications are not subject to the disclosure requirements of the Federal Food, Drug, and Cosmetics Act and FDA regulations.
Article: "FDA Draft Guidance for Print DTCA: Less than Feared," Pharma Marketing News, Vol. 3, #2; REPRINT #32-03.
"[D]isease awareness communications ... are designed to educate patients or health care practitioners about particular diseases or health conditions, and do not promote a particular medical product, with the goal of getting more patients to discuss under-treated conditions with their doctor."
Characteristics of Disease Awareness Communications
"FDA will treat as a disease awareness communications any communications by or on behalf of a
manufacturer, distributor, or retailer of a drug or device that:
- discuss a disease or health condition;
- if consumer-directed, advise the audience to "see your doctor" for possible diagnosis
- if aimed at health care practitioners, encourage awareness of signs of the particular
disease or health condition, or otherwise provide information to assist in the diagnosis of
the particular disease or health condition;
- do not mention a particular drug or device; and
- do not include any representation or suggestion relating to a particular drug or device.
This kind of communication constitutes neither labeling nor advertising and is, therefore, not
subject to the requirements for the disclosure of risk information and other requirements under
the act [Federal Food, Drug, and Cosmetic Act]."
Disease Awareness Communications Directed at Health Care Practitioners
"[D]isease awareness communications can be directed at either
consumers or health care practitioners. In this section, FDA is providing examples of materials
that drug and device firms might disseminate to health care practitioners as disease awareness
communications to help clarify when those communications would not be considered advertising
or labeling subject to the requirements of the act and of FDA regulations.
- Recommendations for screening and treatment of a disease or health condition in
primary care settings (e.g., National Institute of Mental Health screening and
treatment recommendations for depression in men in primary care settings)
- Counseling recommendations for health care practitioners with respect to a
particular disease or health condition (e.g., Alliance for Cervical Cancer
Prevention cervical cancer prevention "fact sheet")