In 2007, pharmaceutical companies spent $4.774 billion on DTC advertising. It was the first year such spending had declined, but it was still six times as much as the industry had spent in 1996. DTC advertising of prescription drugs attracted enough congressional attention to warrant at least six bills in the 110 th Congress as well as concerns from members in the 111 th . Beyond the sheer size of this marketing operation, what are the issues that concern Members? What actions do critics propose—and supporters of DTC ads oppose? Is there common ground between both groups? There is a spectrum of opinion about DTC ads. Proponents of DTC advertising say the ads: educate consumers about medical conditions; alert them to treatments that exist; fairly present risks as well as benefits; detail non-drug approaches to improve health; remind and motivate consumers to comply better with drug therapy regimes; and help to de-stigmatize conditions. Critics of DTC advertising say the ads: minimize the risks of some medications while promoting their benefits; lure patients into expensive drugs when cheaper ones work as well, thus increasing healthcare costs; persuade patients to ignore other medications with fewer side effects and more established safety track records; provide information that would be more credible coming from non-industry sources; and are susceptible to marketing needs that interfere with objective presentations. Not all of these views necessarily conflict. It is possible to educate about medical conditions and omit information about alternate therapies, for example. As Congress considers arguments for and against DTC advertising of prescription drugs, context becomes important. All pharmaceuticals carry some risks. Human drugs, by their definition, are substances intended to affect the structure or function of the body. Consumers can take too much—or too little. They can take drugs that interact with each other in ways not yet understood. Researchers do not know all risks at the time FDA first approves a drug for marketing. In fact, one effect of the 2005 controversy over Vioxx was that it heightened public awareness of how incomplete the data really are before tens of thousands of consumers use a drug in real-life conditions, which include use beyond the carefully controlled limits of clinical trials. Scientists then attributed approximately 100,000 excess heart attacks and sudden cardiac deaths to an unanticipated cardiovascular side effect of that heavily advertised blockbuster drug and others in its class (COX-2 inhibitors developed to treat pain without the associated stomach side effects common to other nonsteroidal anti-inflammatory drugs) before they were withdrawn from the market. While critics and supporters of DTC ads sharply disagree on many things, people all along the spectrum often seem united in their belief that DTC ads should meet four criteria. They must be: Accessible. We want consumers to have access to information that could—along with the treating physician—help them make the healthcare decisions they face. To do so, the information must be understandable , accurate (true), balanced , and up-to-date . Understandable. Although researchers—whether in academia, government, or industry—disagree about what it is that viewers need to learn from advertisements (drug, brand, disease recognition; risks; benefits; indication), they agree ads should present the information so that average Americans can understand it. Accurate and up-to-date . There is little disagreement about whether DTC ads should be accurate and up-to-date. There is, however, disagreement about exactly what those terms mean. When should ads change to include postmarket findings? When risks or benefits vary by age or disease stage and other treatments, how much of these details should the ads present? Balanced . Most players in the debate acknowledge the need for some discussion of the balance between risks and benefits of a drug. They often disagree over the breadth of comparisons (for example, whether to consider other drugs or other treatments or cost) or methods to use. Appearing on TV and radio, and in popular magazines and pop-up windows on the Internet, DTC ads are an anomaly when it comes to federal regulation. The Federal Trade Commission (FTC) regulates most advertising in the United States. In 1962, however, Congress assigned the regulation of prescription drug advertising to the Food and Drug Administration (FDA). In doing so, though, it did not give the agency enforcement authority similar to that granted to the FTC. According to some critics of DTC ads, this has prevented effective oversight, and created a phenomenon more misleading than educational. To other critics, however, FDA's organizational structure, reliance on industry fees, and inadequate appropriations are more important factors in what they see as the agency's less than rigorous enforcement of law and regulation. Nevertheless, support for some form of DTC ads from industry and consumers is strong: industry wants to increase sales, and consumers want to actively participate in decisions about their own health. That, combined with advances in information technology and possible relevance to constitutional protections of free speech, makes an outright ban on DTC ads unlikely. The concerns about DTC ads already expressed by Members of the 111 th Congress are similar to those that have surfaced in the past. Interest in the 109 th Congress was sparked by some Members who had seen its growth and noted controversies over heavily advertised drugs such as Vioxx. Senate and House committees in the 110 th Congress considered drug safety bills that included restrictions on DTC advertising. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85 ) included some of those provisions, such as new industry fees for the advisory review of DTC television ads; expanded authority of the Secretary of Health and Human Services (HHS) to require certain disclosures and statements; and civil monetary penalties for false or misleading ads. So far, Members of the 111 th Congress have indicated interest in DTC advertising in the context of drug safety, tax treatment of advertising expenses, risk communication, and general FDA-activity authority and oversight, sometimes in the context of broader discussions of health care costs and reform. This report examines these and other issues. It (1) describes the current status of DTC drug advertising; (2) analyzes issues surrounding it; and (3) discusses potential options for Congress. Specifically, Part I–Current Picture describes the types, history, and extent of direct-to-consumer drug advertising in the United States; reviews the authority Congress has given FDA to regulate DTC advertising and how FDA has used that authority; and describes voluntary guidelines of some interested groups. Part II–Issues explores what manufacturers, clinicians, and consumers want the ads to achieve; examines how DTC ads affect consumers, clinicians, and drug manufacturers; and discusses the major issues now debated by proponents and opponents of DTC drug advertising. Part III–Potential Options discusses potential oversight and legislative options for Congress; and concludes by relating DTC drug advertising to some of the larger issues affecting U.S. health care: cost, access, safety, among others. The World Health Organization defines "drug promotion" as "all informational and persuasive activities by manufacturers, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs." Richard G. Frank, Harvard Medical School professor of health economics, describes DTC advertising more specifically as "[A]ny promotional effort by a pharmaceutical company to present prescription drug information to the general public in the lay media." Although the Federal Food, Drug, and Cosmetic Act (FFDCA) regulates prescription drug "advertising," Congress did not define the term in the law. In its regulations, however, FDA has listed examples: "advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems." Academic experts in prescription drug law have noted that "FDA generally interprets [prescription drug advertising] to encompass information, other than labeling, that promotes a drug product and is sponsored by a manufacturer." DTC print advertising appears in magazines, newspapers, non-medical journals, pharmacy brochures, and direct-mail letters; companies also run DTC ads on television, radio, videos, billboards, and Internet Web sites. The ads usually fall into one of three categories. Help-seeking ads discuss a particular disease or health condition, advise the consumer to "see your doctor," but do not mention the product's name. They are directed towards consumers, make no health claims, and mention no specific drug. Reminder ads call attention to the product's name but make no reference to the health condition it treats. They make no health claims and FDA does not require that they contain full risk information. Although reminder ads may acquaint consumers with brand names of products, they are directed primarily towards doctors and health care professionals who are more likely than consumers to know about the product and its use. Product-claim ads —the type of most concern to FDA—include a product's name and a therapeutic claim for it. The regulations require that therapeutic claims not be false or misleading and that the ad present full risk information. FDA's regulatory oversight is minimal for the first two, reflecting its statutory authority. The third commands most of its attention and resources. DTC advertising is only one of the pharmaceutical industry's tools to influence prescription drug sales. Companies also promote drugs to physicians. They use direct advertising, such as ads in medical journals; reminders, such as logo-embossed pads and pens; and less well-defined tools, such as industry-funded seminars, residency training support, drug samples, and visits by "detailers," drug company representatives who visit doctors' offices with drug samples and educational materials. Although not a focus of this report, industry promotion to physicians appears to influence prescribing patterns. The pharmaceutical industry increased its DTC spending by 536% from 1996 to 2007. To put this growth in perspective, the Consumer Price Index (all items) (which approximates the change in real dollars of the cost of placing advertising spots increased 24% during the same time period.