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GUIDANCE FOR INDUSTRY1
Consumer-Directed Broadcast Advertisements
I. INTRODUCTION
This guidance is intended to assist sponsors who are interested in advertising their prescription human and animal drugs, including biological products for humans, directly to consumers through broadcast media, such as television, radio, or telephone communications systems.2
The purpose of this guidance is to describe an approach that FDA believes can fulfill the requirement for adequate provision in connection with consumer-directed broadcast advertisements for prescription drug and biological products. The approach presumes that such advertisements:
III. FULFILLING THE ADEQUATE PROVISION REQUIREMENT
A sponsor wishing to use consumer-directed broadcast advertisements may meet the adequate provision requirement through an approach that will allow most of a potentially diverse audience to have reasonably convenient access to the advertised product’s approved labeling. This audience will include many persons with limited access to technologically sophisticated outlets (e.g., the Internet) and persons who are uncomfortable actively requesting additional product information or are concerned about being personally identified in their search for product information. One acceptable approach to disseminating the product’s approved labeling is described below. This approach includes the following components.
A. Disclosure in the advertisement of an operating toll-free telephone number for consumers to call for the approved package labeling. Upon calling, consumers should be given the choice of:
- Having the labeling mailed to them in a timely manner (e.g., within 2 business days for receipt generally within 4-6 days); or
- Having the labeling read to them over the phone (e.g., by offering consumers a selection of prerecorded labeling topics).
B. Reference in the advertisement to a mechanism to provide package labeling to consumers with restricted access to sophisticated technology, such as the Internet, and those who are uncomfortable actively requesting additional product information or are concerned about being personally identified in their search for product information. One acceptable mechanism would be to
C. provide the additional product information in the form of print advertisements appearing concurrently in publications that reach the exposed audience. The location of at least one of these advertisements would be referenced in the broadcast advertisement. If a print advertisement is part of an adequate provision procedure, it should supply a toll-free telephone number and an address for further consumer access to full package labeling. This mechanism of providing access to product labeling has the advantage of also providing considerable information in the form of the required brief summary and in the advertising text itself.
When a broadcast advertisement is broadly disseminated, FDA believes that ensuring that passive and privacy-sensitive information seekers have adequate access to detailed product information is critical to complying with the adequate provision regulatory requirement. Thus, print advertisements associated with broadly disseminated broadcast advertisements should be comparably broadly disseminated in terms of the targeted audiences.
An alternative mechanism for providing private access to product information would be to ensure the availability of sufficient numbers of brochures containing package labeling in a variety of publicly accessible sites (e.g., pharmacies, doctors’ offices, grocery stores, public libraries). Brochures should be available at enough sites so that most consumers exposed to the broadcast advertisement can obtain the labeling without traveling beyond their normal range of activities. This alternative mechanism is likely to be logistically feasible only when the associated broadcast advertising campaign is relatively limited in audience reach.
D. Disclosure in the advertisement of an Internet web page (URL) address that provides access to the package labeling.
E. Disclosure in the advertisement that pharmacists, physicians (or other healthcare providers), or veterinarians (in the case of animal drugs) may provide additional product information to consumers. This statement should communicate clearly that the referenced professional is a source of additional product information.
Telephone advertisements that make a product claim (not reminder advertisements) occur when there is a telephone communication between an individual and a product’s sponsor where both a product name and a representation or suggestion relating to a product (e.g., its indication) are disclosed by the sponsor. Under these circumstances, such advertisements are subject to the disclosure requirements of the Act and the regulations. However, telephone advertisements are different from advertisements broadcast through television and radio. By participating in the telephone communication, the consumer has already indicated his or her willingness to discuss the topic or receive additional information. Consequently, adequate provision for disseminating product labeling in connection with telephone advertisements may be achieved with fewer of the components listed above. For such advertisements, adequate provision could consist of the availability of the option of having product labeling mailed to the caller in a timely manner (e.g., within 2 business days for receipt generally within 4-6 days), or having the labeling read to them over the phone (e.g., by allowing consumers to select from prerecorded labeling topics), as well as disclosing that health care providers are a source of additional product information.
When a broadcast advertisement is presented in a foreign language, the information sources that are part of the advertisement’s “adequate provision” mechanism (i.e., print advertisements or brochures, websites, toll-free telephone number recorded messages or operators) should be in the language of the broadcast ad. Regardless of the language used for the advertisement, current broadcast advertising regulations require the dissemination of approved product labeling, which, in most cases, must be in English, and is generally written in language directed to health care professionals. The Agency strongly encourages sponsors to consider the benefits of also providing consumers with nonpromotional, consumer-friendly product information in the language of the broadcast ad (e.g., FDA-approved patient labeling or accurate, consumer-friendly translations of product labeling information).
The FDA encourages sponsors who use this adequate provision mechanism to collect relevant data on consumer use and make their findings publicly known. FDA also encourages sponsors and other interested parties to make known their research relating to the overall effects of DTC promotion on the public health.
FOOTNOTES
1. This guidance has been prepared by the intra-Agency Group on Advertising and Promotion at the Food and Drug Administration. This guidance represents the Agency 's current thinking on procedures to fulfill the requirements for disclosure of product information in connection with consumer-directed broadcast advertisements for prescription human and animal drugs, and human biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
2. This guidance is not intended to cover the advertising of restricted medical devices, which are subject to the requirements of section 502(r) of the Federal Food, Drug, and Cosmetic Act.