April 1998 Direct-to-Consumer Advertising of Prescription Drugs A background paper prepared by Michie Hunt, Consultant 2 Summary—Since 1985, direct-to-consumer (DTC) addressing diseases or conditions that are primarily advertising of prescription drugs has become a critical cosmetic or that may affect quality of life but do not lead part of pharmaceutical marketing strategy. While the to increased morbidity and mortality. It is likely that the object of such advertising is to stimulate consumer clinical community and payers will need more compara- demand, it may also provide information that promotes tive and cost-effectiveness information as a basis for public health, for example, by increasing diagnosis of rational drug selection. Further, policymakers and disease and improving compliance with prescribed payers may be faced with considering equitable ways to drug regimes. However, the regulatory requirements ration access to the most expensive therapies. that DTC ads must satisfy were originally developed for professional audiences. In light of the increased preva- lence of DTC advertising, policymakers may want to reconsider these requirements to ensure that consumers Since 1985, direct-to-consumer advertising of can understand the benefit and risk information such prescription drugs has grown from nothing into a ads contain. significant market force. By 1997, the pharmaceutical industry was spending nearly a billion dollars a year on DTC advertising has proved highly successful in this form of promotion, placing it on a par with con- stimulating consumer demand for prescription drugs. sumer product industries that rely on direct advertising Today, patients often initiate conversations with their to promote national brands. Regulation may have doctors about the advertised medications and even ask impeded the early growth of consumer advertising of for them. It is unclear how well-equipped physicians are prescription drugs. By the 1990s, however, companies to respond to such requests, especially as the universe of that used it had achieved so high a return on their approved drugs continues to expand. Most medical investment that it became, seemingly overnight, a major school curricula place little emphasis on therapeutics. engine of sales and earnings growth. Today, regulatory Once doctors have received their training, they often requirements are moderating and industry observers depend heavily on commercial sources of information expect DTC advertising to continue to expand. about drugs. Improving medical school training in therapeutics and ensuring a flow of unbiased, high- This explosion in consumer-oriented promotion is a caliber research on drugs would give physicians informa- sign that pharmaceutical companies have shifted their tion critical to providing good care. A demonstration strategy in response to structural changes in the health program that would establish one or more centers for care market. In the current managed care environment, education on research and therapeutics, authorized by drug manufacturers increasingly face purchasers, such as the Food and Drug Administration Modernization Act of health maintenance organizations (HMOs) and pharmacy 1997, addresses the clinical community’s need for such benefits managers (PBMs), that put restrictions on research and may also help satisfy consumers’ desire for consumer access to some prescription drugs. As a result, reliable and objective information. they have often found it more difficult to introduce new products, especially those that cannot demonstrate In addition, the potential contribution of pharma- significant therapeutic advances or cost savings over cists to improved prescribing practices deserves atten- existing therapies. In response, they have gone directly to tion. There is a growing body of evidence that pharma- the consumer. Evidence is growing that this strategy has cist intervention can reduce the risk of adverse drug been successful in motivating patients to approach their events in hospitalized patients, especially older ones doctors with requests for specific prescription drugs. with polypharmacy. Some evidence is also emerging Physicians, so far, have tended to accommodate these that pharmacist counseling of ambulatory patients, requests. In effect, the pharmaceutical industry has been especially those who are prescribed high-risk medica- able to circumvent managed care barriers to the consumer tions for serious diseases, can reduce the incidence of retail market. It may also have challenged professional adverse events and, consequently, decrease health control over prescription decisions. system utilization and costs. For the moment, DTC advertising appears to be Finally, DTC advertising is likely to contribute to the helping pharmaceutical companies regain ground in the already high inflation in prescription drug spending. struggle to control the retail prescription drug market. While its impact on total health system costs is unknown, However, the rapid expansion of consumer promotion some are concerned that it may stimulate demand for raises questions about the appropriateness of the products whose benefits are not commensurate with existing regulatory framework, the health care system's their costs. This is particularly true for new products ability to deal with a surge in patients' requests for 3 drugs, and the impact that increasing demand will have over drug advertising, however, remained with the on health system costs. Federal Trade Commission (FTC) until 1962, when the Kefauver Harris Drug Amendments (the amendments) transferred jurisdiction over prescription drug advertis- EARLY REGULATION ing to the FDA, while leaving the FTC with jurisdiction Traditionally, the advertising of prescription drugs over the advertising of over-the-counter products.5 was limited to medical journals or health care trade Some analysts have argued that when Congress enacted publications aimed at physicians. In 1981, the pharma- the amendments, its sole concern was to ensure that ceutical industry raised the question of a new kind of drug advertisements to physicians would not mislead advertising that would recommend such drugs directly them or negatively influence their prescribing practices. to consumers. Two years later, FDA Commissioner In 1962, direct-to-consumer advertising of prescription Arthur Hull Hayes, Jr., M.D., asked for a voluntary drugs was unthinkable for policymakers and regulators.6 moratorium on such advertising to enable the agency and other interested parties to pursue research on its In the two decades following passage of the amend- likely effects. During this moratorium, several studies ments, the FDA developed an extensive set of regula- of varying rigor were conducted. Most of these investi- tory requirements for prescription drug ads that ap- gated public attitudes toward DTC advertising and, peared in medical journals and health-related trade more generally, consumer demand for health care publications. These requirements derived authority from information. With some exceptions, they suggested that Section 502(n) of the act, which requires that all pre- consumers wanted more information about prescription scription drug advertising include “such...information drugs and would tend to view DTC advertising favor- in brief summary relating to side effects, contraindica- 1 tions, and effectiveness as shall be required in the ably. Further, an FDA-commissioned study showed 7 that both print and television advertisements were regulations.” Some of these requirements address the capable of communicating information about risk as principal features that a prescription drug advertisement well as about benefit to consumers, even though test must have (for example, warnings and contraindica- subjects tended to retain more information regarding tions). Others specify what such an ad must not do. In benefit than risk. The study also revealed that the particular, an advertisement is deemed to violate format in which risk information is conveyed—that is, Section 502(n) if it is false, misleading, or lacking in whether it is through print or through broadcast “fair balance.” media—affects the level of understanding in the reader Thus, from Section 502(n) of the act flowed a set of or viewer.2 standards that were well-established by the time the In September 1985 the FDA lifted its moratorium on FDA withdrew its moratorium on consumer advertising: DTC advertising by publishing a Federal Register Regulation required that “product-claim” advertise- notice. The notice stated that current regulations gov- ments, that is, those that recommend a drug for a erning prescription drug advertising provided “suffi- particular disease or condition, present a fair balance 3 cient safeguards to protect consumers.” While not of benefit and risk information. For example, claims expressly forbidding DTC advertisements, the agency of safety and efficacy had to be balanced with rele- thus indicated that existing standards, which had been vant disclosures of risks and limitations of efficacy. developed to regulate advertisements directed to These were to be reasonably prominent and readable physicians, must be followed for DTC advertising as in the main body copy of the advertisement. well. This action both cleared the way for DTC adver- tising of prescription drugs and set in place a regulatory Regulation required all product-claim advertise- structure for consumer advertising whose effectiveness ments to contain the “brief summary” of comprehen- has