| Sarah Powell of Liquent investigates the strategy adopted by the US regarding prescription drug advertising and promotion compliance
In 1962, The United States Congress passed the Kefauver-Harris Drug Amendments to the Food, Drug and Cosmetic Act. These amendments transferred the regulation of prescription drug advertising from the Federal Trade Commission to the Food and Drug Administration (FDA). The Center for Drug Evaluation and Research (CDER) states that part of their mission is to “assure that prescription drug information provided by drug firms is truthful, balanced, and accurately communicated.”
Advertising is defined in 21 CFR 202.1(l)1. This regulation states that “advertisements subject to Section 502(n) of the Food, Drug and Cosmetic Act include advertisements published in journals, magazines, other periodicals and newspapers; and broadcast through media such as radio, television and telephone communications systems.” According to CDER’s Division of Drug Marketing, Advertising and Communications (DDMAC), the list provided in 21 CFR 202.1(l)1 is not a comprehensive list of advertising media subject to regulation. Other examples include advertising by sales representatives, computer programs, faxes and electronic bulletins. The FDA has issued many guidance documents covering acceptable advertising and promotion activities. Each centre has a different division responsible for enforcing these regulations, in turn producing different standards depending on the product type (see Figure 1).
REQUIREMENTS FOR ADVERTISING AND PROMOTIONAL MATERIALS
The regulations outline requirements for ingredient information including rules for placement and prominence of proprietary and established names. In addition, 21 CFR Part 202.1(e) states that advertisements must include a “true statement of information in brief summary relating to side effects, contraindications, and effectiveness.” The regulations clarify that when interpreting this section, ‘contraindications’ includes all side effects, warnings, precautions, cautions, special considerations and important notes. When the advertisement is broadcast via media, such as television or radio, information on major side effects or contraindications must be included in the audio or audio and visual portions of the presentation, unless the advertiser makes adequate provisions to disseminate the approved product labelling. |
