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57 Food & Drug L.J. 423 (2002)
The Development of Direct-to-Consumer Prescription Drug Advertising Regulation

handle is hein.journals/foodlj57 and id is 443 raw text is: The Development of Direct-to-Consumer Prescription Drug Advertising Regulation Ficis B. PALuivmo, PH.D., J.D.* AND C. DANiEL MuLI s, PH.D.* * I. INTRODUCTION Direct-to-consumer (DTC) prescription drug advertising is now well known to prac- tically all American households. One needs only to watch virtually any commercial television program or to browse through any consumer-directed magazine to view ad- vertisements for a variety of prescription drugs. With regard to broadcast media, this is a relatively new phenomenon because, for many years, pharmaceutical manufacturers were reluctant to advertise their products directly to the consumer because of the brief summary requirement of the food and drug law and regulations. These historically have required that an advertisement contain a brief summary, which requires a sub- stantial amount of material about the drug product's side effects, contraindications, and effectiveness. Advertisements for prescription drugs were directed toward the ultimate decision-makers, the prescribers. Recent changes, however, in the Food and Drug Administration's (FDA's) guidance-introduced in 1997 and finalized in 1999-have opened the door to a plethora of advertisements, obviously designed to alter the decisionmaking balance between patients and physicians. The growth of DTC advertising over the past eleven years has been exponential. Although there are numerous sources with slightly varying DTC expenditure figures, most reports provide numbers that are similar to those shown in Table 1, below. Table 1 Year DTC Spending 1989 $12 million 1990 $48 million 1991 $56 million 1992 $156 million 1993 $166 million' 1994 $242 million 1995 $313 million 1996 $595 million 1997 $844 million 1998 $1.17 billion 1999 $1.58 billion 2000 $2.24 billion 2001 $2.38 billion2 'Dr. Palumbo is Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy, Baltimore, MD. Dr. Mullins is Associate Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy, Baltimore, MD. The authors gratefully acknowledge the support of the Henry J. Kaiser Family Foundation. In addition, the authors acknowledge the assistance of University of Maryland School of Law students, Jennifer Kim, Kelly Trumpbour, Jean Kim, and Karena Cooper; and University of Maryland Pharma- ceutical Health Services Research graduate students, Ashley Slagle and Prasun Subedi. ' The DTC spending figures for years 1989 to 1998 came from the table titled Direct-to- Consumer Spending Over Time in 18 MED. AD. NEWS 20 (June 1999). 2 The figures for years 1999 and 2001 came from the table titled Annual Direct-to-Consumer Advertising Expenditure for Prescription Brands in 21 MED. AD. NEWS 42 (June 2002). 423

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