The purpose of this paper is to investigate the changing legal landscape associated with the growth of advertising of prescription drugs directly to the consumer, and makes recommendations designed to assist advertisers in avoiding legal liability based on those advertisements.
This study investigates the phenomenal growth of DTC advertising since 1997, when a profound change in the FDA regulations took effect. These changes permitted advertisers significantly more flexibility in providing information about the advertised drug directly to the consumer. Since then, however, DTC advertising has repeatedly come under attack. A review of the literature, changing law, and other factors, reveals the primary criticisms of DTC advertising, and its tendency to expose pharmaceutical advertisers to legal liability.
The paper recounts the development of the law concerning pharmaceutical advertising, and particularly, the application of the Learned Intermediary Rule. Previously, this Rule operated to shield pharmaceutical companies for liability by passing liability on to the physician who wrote the prescription for the drug. Now, that law is changing, with resulting liability for pharmaceutical advertisers.
The study recounts the primary criticisms of DTC advertising, and provides a number of steps that can be taken to help avoid legal liability for pharmaceutical companies that engage in DTC advertising.
The study looks at DTC advertising from both a marketing and a legal perspective, and combines those disciplines to draw conclusions helpful to DTC advertisers.
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