Comm 3444 Chapter 13 Controversies in Contemporary Advertising Advertising Prescription Drugs Healthy Tactics or Risky Population Direct to Consumer DTC Advertising Prescription drug print advertising directed to consumers been used since the late 1980s Types of DTC Advertising The pharmaceutical industry is unique in several ways Based not only on production but also on creation It is a truly international business with international sales necessary to recoup investment costs Three types seen Health Seeking Advertising Provides information on a specific condition but does not mention a branded drug Reminder Advertising Contains the name of a branded drug but does not make any claims about the product or mention the condition that the drug treats Brand Advertising Messages that contain a brand name as well as product specific information about the drug Guidelines for DTC Brand Advertising In the U S DTC advertising is regulated by the FDA In Canada a federal department called Health Canada regulates prescription drugs including advertising By far U S regulation and policy is the most detailed and intensive Kefauver Harris drug amendment 1962 Set strict guidelines for all pharmaceutical advertising in the US Advertised drugs be proven safe and effective and advertisements are not false or misleading Present a fair balance of the risks and benefits of using the drug Contain facts that are material to the product s advertised uses Promotional material must include a statement that provides all the information from the product s approved labeling to facts regarding side effects and contraindications Until 1981 all prescription drug advertising was directed to physicians and other medical professionals In 1985 the FDA decided to allow DTC advertising Advertisers in the late 1980s had to use reminder or health seeking advertising because of the long requirements of brief summaries in television ads In 1997 the FDA released a draft set of guidelines for broadcast advertising and a finalized set of guidelines was released in 1999 New set of guidelines eliminated the brief summary requirement replacing it with a major statement a reduced brief summary containing the drug s major risks and contraindications Federal Food Drug and Cosmetic Act Requires that anyone who advertises prescription human and animal drugs in print media must disclose certain information about the drugs uses and risks Today DTC print advertisements currently function largely as repositories of highly technical data For television advertisers must provide alternative methods of acquiring info since brief summary requirements are more lenient Adequate Provision Currently all advertising is reviewed and approved by the FDA s Office of Prescription Drug Promotion Intended Effects Consumers learn information about health care choices DTC ads develop trust in messages and in medication Increased awareness of a variety of diseases Unintended Effects Compliance with treatment Incomplete information Creation of distrust Creation of Distrust Lack of retention of important information Misinformation regarding governmental role Possible influence on prescription drug costs Unnecessary or inappropriate prescriptions Challenge to physician s authority
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