Clinical and Health Affairs
Direct-to-Consumer Prescription Drug Advertising
History, Regulation, and Issues
By Jisu Huh, Ph.D., Denise E. DeLorme, Ph.D., Leonard N. Reid, Ph.D., and Soontae An, Ph.D.
Abstract
Direct-to-consumer advertising has changed the way prescription drugs are marketed in the United States. This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.
Direct-to-consumer (DTC) advertising of prescription drugs is a relatively new phenomenon. However, during the last two decades, it has radically changed the way such drugs are promoted. Traditionally, most marketing efforts by pharmaceutical manufacturers focused on direct-to-physician advertising in medical journals and personal visits by detailing salespeople. However, changes by the Food and Drug Administration (FDA) in 1997 to its regulation of drug advertising were followed by a dramatic increase in the amount of DTC advertising, especially in broadcast media. Today, DTC advertising is a mainstay of pharmaceutical marketing. This article provides a brief overview of the history and regulation of DTC advertising and the concerns that surround it.
History of DTC Advertising
The practice of advertising pharmaceutical products directly to consumers has a long history in the United States. During the 18th and 19th centuries, patent medicines—drug compounds with colorful names—were advertised in newspapers, often with misleading and deceptive claims. By the early 20th century, patent medicine ads accounted for nearly half of newspapers’ advertising revenue. Marketing of such compounds was completely unregulated until 1906, when Congress passed the Pure Food and Drug Act. The law, however, had little impact on deceptive advertising practices because it was directed only at product labels.1
In 1938, Congress repealed the 1906 legislation and passed the Food, Drug, and Cosmetic Act, providing the framework for contemporary pharmaceutical advertising regulation. The 1938 law required that a drug be proven safe and receive FDA approval before it could be marketed. It also required that these products carry a label with adequate directions for their use.2 The Food, Drug, and Cosmetic Act did not distinguish between prescription and over-the-counter (OTC) drugs, however. It was not until 1951, when Congress enacted the Durham-Humphrey Amendments to the law, that the two drug categories were created.3 Before that, the classification of a drug as prescription-only was largely at the discretion of the manufacturer.
Prior to 1962, the Federal Trade Commission (FTC) had jurisdiction over all advertising, including prescription drug advertising. That year, the Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act transferred jurisdiction of prescription drug advertising from the FTC to the FDA, strengthening the premarket review process for such drugs.1 Since then, the FDA has been the primary regulator of prescription drug advertising, including that aimed at consumers, while the FTC retains authority to regulate OTC drug advertising.
Although Congress has differentiated advertising of prescription drugs from that of OTC drugs, no formal regulations have set DTC advertising apart from direct-to-physician advertising.3 Until the early 1980s, pharmaceutical advertising was mainly aimed at medical professionals. In 1983, after companies had begun advertising directly to consumers, the FDA requested a voluntary moratorium on DTC advertising. Two years later, the moratorium was lifted without any new regulations or requirements. The FDA only required that DTC ads meet the same legal requirements as direct-to-physician ads and include a brief summary of the drug’s side effects, contraindications, warnings, and precautions, and provide “fair balance” between the drug’s risks and benefits.4
In 1997, DTC advertising took an important turn when the FDA loosened its requirements for broadcast DTC ads. The new rules, which were finalized in 1999, required that broadcast ads need only provide information about major risks instead of a brief summary of risks and warnings. Under the new requirement, ads must disclose the drug’s major risks and most common adverse effects in the audio or audio/visual parts of the presentation. In addition, DTC ads may make adequate provision for dissemination of package labelling information by referring consumers to a toll-free telephone number, a website, print ads, or their health care providers.5
Regulation of DTC Advertising
The FDA identifies three types of DTC ads: 1) reminder ads that include no reference to the drug’s purpose, benefits, or risks, and that refer to the drug’s brand name only, 2) help-seeking ads that contain information about a disease or medical condition without mentioning the drug’s brand name, and 3) product-claim ads that include both the drug’s brand name and contraindications.6 Product-claim ads are the most common and controversial type of DTC advertising and are the ones regulated by the FDA.
The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) oversees DTC advertising, monitoring ads to make sure information is “truthful, balanced, and accurately communicated.” Drug companies may voluntarily submit draft versions of DTC advertising materials for advisory comments.1 However, the FDA does not mandate a premarket review of DTC advertising unless the drug was approved on an accelerated basis. Drug makers must submit final DTC ad materials to the DDMAC at the time of initial product dissemination.
If the DDMAC finds that a DTC ad does not comply with FDA guidelines, it may issue a notice of violation or “untitled letter” for minor violations or a warning letter for more serious violations. The DDMAC issued 12 warning letters in 2004, five in 2003, and one in 2002.7 More recently, the Food and Drug Administration Amendments Act of 2007 authorized the FDA to impose civil penalties for false and misleading ads.8
In addition to the FDA, a number of organizations do their own policing of advertising. The National Advertising Division (NAD), founded in 1971 by the Council of Better Business Bureaus, is the major self-regulatory body for advertising, including pharmaceutical advertising. Complaints can be filed by competitors, consumers, or the NAD itself. These complaints typically involve issues related to the truth or accuracy of national advertising. The National Advertising Review Board (NARB) is the appeal board that reviews NAD decisions. NAD/NARB decisions are not legally binding and compliance is voluntary. However, NAD/NARB decisions are rarely challenged. If an advertiser fails to comply, the NAD/NARB can refer the case to the FTC or the FDA, depending on whether the drug is prescription or OTC. Other self-regulatory bodies include various media associations (eg, the National Association of Broadcasters) and professional advertising associations (eg, the American Advertising Federation). These groups have self-governance systems and codes of conduct that supplement the FDA and FTC requirements.
Prescription drug advertising is also regulated by the pharmaceutical industry through the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA has developed a 15-point voluntary guideline for DTC advertising, which has been adopted by 25 pharmaceutical companies.9 The key points are: to comply with FDA guidelines, emphasize risks and benefits in ads, delay ads for new drugs until doctors have sufficient time to learn about them, and submit all television ads to the FDA for review.
Current State of DTC Advertising
Since the FDA’s regulatory change in 1997, DTC advertising has expanded exponentially. DTC advertising became one of the fastest-growing advertising categories in the 2000s. In 2006, spending on DTC advertising reached almost $5 billion. However, expenditures have lagged for the past two years as a result of the economic downturn and because companies have been waiting longer to market fewer new drugs with more limited indications (Figure).10-12
A limited number of blockbuster drugs tend to account for a large share of DTC ad spending: The top 25 DTC- advertised brands accounted for 62% of total DTC ad spending in 2008.13 These highly advertised products tend to treat a few disease types: depression, asthma, coronary artery disease, insomnia, and erectile dysfunction.
The growth of DTC advertising has been driven by structural changes in the health care market, especially the adoption of managed care. For example, health maintenance organizations usually prefer cheaper generic drugs to more expensive name-brand ones, thereby limiting pharmaceutical companies’ ability to influence physicians through traditional marketing tools. In an attempt to regain control of the retail prescription drug market, companies shifted their focus in the late 1990s from direct-to-physician to DTC marketing.14,15 The DTC ad spending boom has also been linked to increased consumer awareness and interest in prescription drug advertising.16-18
Drug manufacturers’ increased commitment to DTC advertising has generated controversy among legislators, health care professionals, regulatory organizations, ad experts, and consumer advocates. Opponents call for more stringent oversight to protect consumers from detrimental and socially undesirable effects of DTC advertising. Among their claims are that DTC advertising confuses and misleads consumers, interferes with the physician-patient relationship, stimulates unnecessary demand for drugs (especially for costly brands), leads to inappropriate prescription drug use, and contributes to rising health care costs.19-23
Supporters claim that, despite these concerns, DTC advertising can inform and educate consumers, prime them to ask more informed questions when they see their doctor, lead to the identification and treatment of undiagnosed medical conditions, enhance physician-patient dialogue, result in better patient compliance and fewer adverse medical events, and lead to increased competition and lower prescription drug prices.24,25
One point on which both critics and proponents appear to agree is that more empirical research is needed to answer important questions about the effects of DTC advertising practices, especially as they relate to public health, health care costs, corporate responsibility, advertising ethics, physician/patient dynamics, and consumers’ ability to understand and use medical information.
Conclusion
This brief overview of the history of DTC advertising highlights several findings with important implications. First, pharmaceutical advertising spending in the United States has increased substantially in recent years. Advertising appears to be an important driver of the purchase and consumption of pharmaceuticals. Second, people in the United States today are more empowered consumers of health care than ever before. They seek more information about traditional as well as alternative medicines. Advertising, although intended for profit, appears to play a role in helping fulfill their need for information. Third, there are still many gaps in our understanding of the influence of DTC advertising on consumers and further research is needed. Despite substantial study of DTC advertising, questions remain, especially regarding outcomes. There is a lack of evidence about whether such ads are beneficial or harmful to a patient’s health. In addition, there has been limited empirical study of how physicians respond to patients’ inquiries about and requests for an advertised drug. Further studies are needed to explore the effects of DTC ads on the appropriateness of drug use, compliance with drug instructions, adherence to preventative health measures, use of health care services, and changes in pharmaceutical costs.
However, appropriate and socially responsible approaches to the promotion of new drugs is of paramount importance. Unfortunately, incomplete or inaccurate information in ads persists. Thus, there is a need to educate consumers about the limitations of government oversight of pharmaceuticals and about how to critically assess the quality of information in advertisements aimed at them. At the same time, we may need additional training and incentives for health care providers to make sure their patients understand all the risks and benefits of new drugs.
Advertising related to products that affect consumers’ health is a complex domain. Although pharmaceuticals have long been marketed directly to consumers in the United States, DTC advertising continues to generate controversy, and regulatory concerns remain. MM
Jisu Huh is an associate professor in the School of Journalism and Mass Communication at the University of Minnesota, Denise DeLorme is a professor at the University of Central Florida, Leonard Reid is a professor at the University of Georgia, and Soontae An is an associate professor at Kansas State University. They are co-authors of the forthcoming Handbook of Health Communications, second edition, which includes a chapter on DTC advertising.
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