How the US rules on drug advertising came about
The US rules on advertising prescription drugs to consumers were built up over a century of legislation and regulation, from the 1906 Food and Drugs Act to the FDA's guidance on broadcast advertising at the end of the 1990s. The framework sorts advertisements into categories by what they say, and the FDA's evidence on what advertising to consumers does was mixed.
A century of legislation and regulation
Advertising of prescription drugs directly to consumers has increased significantly since 1997, when the FDA re-evaluated its regulations and made advertisements feasible in the broadcast media of the time, television and radio. Most articles in the debate on the practice cite that 1997 shift in FDA policy. Many give limited historical context, focusing on that single decision, and a few of the more extensive reviews extend the timeline to the 1980s, when the first modern examples appeared on television. The US government's position on the practice as of 2008, however, had more than a century of developments behind it. Advertising to consumers has been prominent in US media since the late 1990s, a sign that companies are refocusing again on the final consumer, and although the change may appear recent and significant, advertising to the consumer has a much longer history in the United States.
The 1906 Food and Drugs Act prohibited interstate commerce in misbranded and adulterated food and drugs and established the FDA's regulatory authority, but it regulated the marketing claims of drug manufacturers and salespeople only to a limited degree. In the first major case on marketing claims, United States v Johnson in 1911, the Supreme Court ruled that the Act required manufacturers and salespeople to divulge the ingredients or identity of a drug accurately. The Act did not prohibit false therapeutic claims, so as long as an agent was properly identified, manufacturers and salespeople could legally claim that it could be used to treat or cure any disease. In 1912 Congress responded with the Sherley Amendment, which prohibited labelling medicines with false therapeutic claims specifically intended to defraud purchasers, but the FDA reported that intent to defraud was a standard too difficult to prove in a court of law. In 1933 the FDA recommended a complete revision of the 1906 Act and asked for the authority to prosecute false therapeutic claims, but major change was legislated only after a catastrophe, the deaths from elixir sulfanilamide. The Federal Food, Drug, and Cosmetic Act that Congress passed in response in 1938 eliminated the Sherley Amendment, with its requirement to prove that false therapeutic claims were specifically intended to defraud purchasers. Under the Wheeler-Lea Act, the Federal Trade Commission was authorised to oversee advertising associated with products, pharmaceutical agents among them.
Also in 1938 the FDA required that sulfanilamide and other selected drugs be administered under the direction of qualified experts, which laid the foundations for drugs purchased by prescription only. The 1951 Durham-Humphrey Amendment established a list of drugs that required medical supervision and restricted their sale to prescription by licensed practitioners. As a result of these regulations, manufacturers shifted their advertising and marketing from the general public to the qualified experts who could in turn recommend the drugs. The 1962 Kefauver-Harris Amendments gave the FDA the responsibility and authority to regulate the advertising of prescription drugs. Through the 1980s the FDA did not prevent manufacturers from advertising to the general population, but companies in general focused their advertising on health care professionals, and the absence of marketing to consumers was primarily a result of their lack of attention to the health care consumer.
In 1980 not a single drug promotion appeared on US television. During the 1980s the industry started to redirect its marketing to the general public, advertising for recognised nonserious conditions such as arthritis; in the early 1980s, for example, Rufen was advertised on television for arthritis pain. The FDA requested a voluntary moratorium in 1982 while it evaluated the shift of advertising toward consumers and away from practitioners, and lifted it in 1985, after which advertising to consumers gradually increased. In the early 1990s companies began advertising for more serious conditions such as migraine and epilepsy.
In 1993 the FDA requested that companies voluntarily submit marketing and advertising materials aimed at patients and the general public for review and comment, and mandated that these materials list all side effects and contraindications. The materials had to devote equal space to advertising and to risk communication, so a magazine page of advertising for a drug needed a second page of risk information; print accommodated this easily, but companies found television and radio advertising impractical. In its 1997 preliminary guidance, Guidance to Industry: Consumer-Directed Broadcast Advertising, the FDA permitted promotional advertisements on broadcast media that did not devote an equal amount of time to promotion and risks, as long as sources for more information were provided. After the final guidance of 1999, companies began large marketing campaigns. In 2002 the FDA's authority to regulate advertising to consumers was challenged, one company holding that it violated the company's First Amendment right to freedom of speech; the reported outcome was that the advertising was not banned in the United States and the FDA could continue to regulate it as part of its mandate to protect consumers.
The categories of advertisement
As of 2008 the FDA categorised advertising to consumers into three types: the product-claim advertisement, which names the product and its therapeutic use; the help-seeking advertisement, which discusses a disease and encourages a doctor's visit without naming a product; and the reminder advertisement, which names the product without referring to the disease. Only the product-claim type fell under the agency's jurisdiction, and its therapeutic claim had to be accurate and not misleading. A print version had to keep a fair balance between the space given to benefit and risk information and the space given to a summary of side effects, contraindications and precautions taken directly from the product's label. A broadcast version, usually thirty to sixty seconds long, had to state important risk information clearly and direct the audience to a source of more information, such as a website, a toll-free telephone number, a health care provider or a print source with a large circulation.
The debate and the evidence on advertising to consumers
As of 2008 the United States and New Zealand were the only countries that allowed prescription drugs to be advertised to consumers. The United States was then the largest market for such advertising and accounted for approximately 50% of global pharmaceutical sales. The practice has been vehemently debated: the primary argument in its favour is that it provides disease and treatment information to health care consumers, and opponents argue that it can have harmful consequences, a chief concern being that consumers may not adequately comprehend the use, benefits and risks of products as technical as prescription drugs. Because the primary arguments on both sides scrutinise the role of health information, the advertising is an important consideration for medical writers. Much of its technical information comes from the documentation produced during drug development. The FDA has noted the increase in advertising to consumers and the crucial role of regulation, holding that accurate and complete information is vital to the safe use of drugs.
Starting in 1999 the FDA investigated the impact of the advertising through large surveys of patients and physicians. In its final report, published in 2004, it concluded that the advertising appears to increase awareness of conditions and treatments, motivate questions for health care providers and help patients ask better questions, but in the same survey patients gave a modest rating to the understandability of a product's risks. The FDA's conclusions were mixed, finding both a positive and a negative impact, and a 2008 review of the regulation judged that because the negative impact did not appear to outweigh the positive benefits, the FDA would probably continue to permit the advertising.