Broadcast advertising

The FTC can assess penalties under the Rule against manufacturers for violations of the above requirements. The Rule also states that energy-use-related representations regarding covered products, including print and broadcast advertisements, must be based on the DOE test procedures. 

FDA, Guidance for Industry Consumer-Directed Broadcast Advertisements. Washington, DC FDA, Draft July 1997, Final August 1999. 

Sponsors are required to submit copies of promotional materials, for example, journal advertisements, detail pieces such as file cards, etc. to FDA at the time of initial dissemination. This means that the sponsor is to submit them to FDA simultaneously with the use of that piece or program. It is also possible for companies to engage FDA in review of proposed programs or advertisements, in order to gain feedback on acceptability. This is particularly important for broadcast advertisements aimed at consumers, such as those viewed on television. If promotional materials are deemed to be violative by FDA, for example, if they are false and misleading, a sponsor must withdraw the advertisements and in some cases undertake new campaigns to correct the objectionable statements. 

The prescription drug advertising regulations (21 CFR 202.1) distinguish between print and broadcast advertisements. Print advertisements must include the brief summary, which generally contains each of the risk concepts from the product s approved package labeling. Advertisements broadcast... 

Sponsors of broadcast advertisements are also required to present a brief summary or, alternatively, may make adequate provision. .. for dissemination of the approved or permitted package labeling in connection with the broadcast presentation (21 CFR 202.1(e)(1)). This is referred to as the adequate provision requirement. The regulations thus specify that the major statement, together with adequate provision for dissemination of the product s approved labeling, can provide the information disclosure required for broadcast advertisements. 

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 ... 

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. 

Although the industry claims that DTCA has educational value, an analysis of print and broadcast advertisements reveals significant information gaps in both. Most print ads did not contain basic elements of information a person might need to assess the usefulness of a treatment, such as how a drug works (missing in 64 per cent) or the likelihood of treatment success (missing in 91 per cent). Only 29 per cent of... 

In 1997, the FDA s Draft Guidance on direct-to-consumer broadcast advertisements allowed radio, television, and telephone communications to discuss the risks associated with medications differently than in reminder and help-seeking advertisements. The audio or the audio-visual components of the adverhsement had to contain a major statement of the most important risks, and adequate provisions had to be made for four additional sources for the full label information (brief summary). ... 

Draft Guidance for Industry on DTCA Allowed broadcast advertisements to contain limited risk and benefit information Required adequate provision for alternative sources of complete labeling information... 

In 1997 the FDA again addressed the definitional question, issuing guidelines to clarify what constituted adequate provision for broadcast advertising. Under the new guidelines, drug broadcasts had to refer the audience to four sources to obtain further information ... 

FDA Guidance for Industry Consumer-Directed Broadcast Advertisement. August 1999 www.fda.gov/cder/guidance/ index.htm. 

US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research, Center for Biologies Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry. Consumer-directed broadcast advertisements, August 1999. 

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