The Role of Mass Media in Forming Direct-to-Consumer Advertising Policy in the U.S. and EU

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EXECUTIVE SUMMARY

This study analyzes key international mass media issues related to the U.S. and European Union regulation ofdirect-to-consumer advertising (DTCA) of prescription drugs. The study charts the similarities and differences between U.S. and EU policy on DTCA during 2005. The role of key stakeholder groups in both the U.S. and EU and their probable effect on EU public policy are also noted. A content analysis provides insight into the role played by international mass media in forecasting the advertising policy. This study provides insight into how mass media and key stakeholders may influence public policy on this international health issue.

Keywords: Advertising, mass media, public policy

INTRODUCTION

was found to have severe side effects, and Oraflex was voluntarily withdrawn from the market by the manufacturer (Basara, 1992). The ill effects caused by the drug were made worse through a successful direct-to-consumer advertising campaign and highlighted the potential hazards involved in indiscriminate advertising of pharmaceutical products (Basara, 1992). In February 1983, the FDA imposed a moratorium on all prescription drug advertisements to allow time to consider regulations to safeguard consumers (Basara, 1992). The ban ended in 1985 with the FDA concluding that information required to be placed in direct-to-consumer advertisements should be the same as that provided in pharmaceutical promotions to physicians. As a result of the FDA decision, all such advertisements were required to provide full disclosure and a brief summary of potential side effects, contraindications and the effectiveness of the drugs. These policy decisions served to squelch DTCA as the new policy brought direct-to-consumer informational requirements in line with product labeling (Dukes, 2001).

For some time following this decision, broadcast direct-to-consumer advertisements proved too costly and cumbersome for manufacturers of pharmaceutical products. However, drug manufacturers soon discovered a loophole allowing them to broadcast messages affordably. If manufacturers opted not to disclose the specific use of the product, full disclosure of the side effects was not required. Consequently, manufacturers turned toward "reminder" advertisements: referring to the product name but not the purpose, and "help seeking" advertisements mentioning the manufacturer name but not product names, discussing relevant conditions, diseases and symptoms they intended to treat (Donohue and Berndt, 2005). In response to public demand for information and clarity about these drugs, the FDA issued a Federal Register Notice, declaring a public hearing to discuss DTC advertising on August 16, 1995, and another notice on May 16 the following year to clarify additional issues. Given advancements in the consumer's ability to access additional product information, the FDA reconsidered their policy of the requirement for full disclosure in advertisements.

In August 1997, the FDA issued draft guidance overturning the burdensome informational requirement. The legislative change employed the "learned intermediary doctrine" whereby detailed information concerning side effects and related matters need not be mentioned in direct-to-consumer advertisements on condition they were effectively communicated to physicians, who ultimately approve the prescription of the product to the end user (Pratt & Kuckelmen, 2000). Advertisers were allowed, once more, to affirm the product's specific purpose on broadcast media, provided they referenced four alternative sources of product-labeling information. Typically, these included a toll-free telephone number, an informational web site, a reference to a print advertisement, and a referral to a physician or pharmacist (Pratt and Kuckelmen, 2000). Although the draft guidance was not officially passed until 1999, the milestone decision prompted routinely broadcast pharmaceutical advertisements that also appeared on billboards, newspapers, magazines and the Internet (Dukes, 2001). …