What really happens is that pharmaceutical companies create demand for their product by flooding consumers with advertisements convincing them that they need treatment. Since the Food and Drug Administration changed its policies in 1997 to allow pharmaceutical companies to advertise on air, many doctors have argued that there is a growing movement of patients looking for unnecessary drugs. This puts pressure on physicians to prescribe medications to their patients that they believe are not in the best interest of the patient. The PPI debate in the late 1970s raised the issue of consumer awareness of prescription drugs, their use and their risks. In the early 1980s, some pharmaceutical marketers began to rethink traditional advertising models based solely on advertising to physicians. They started with public relations techniques rather than paid advertising (Pines 1999). For example, shortly after the introduction of Syntex, an analgesic, in the UK in 1978, it became a topic of discussion in talk shows and its use accelerated rapidly. As a result, some pharmaceutical companies have begun to consider the risks and benefits of communicating directly with the public about their products (Smeeding, 1990). Pfizer launched a public relations campaign called Partners in Health Care in the early 1980s to raise awareness of underdiagnosed conditions such as diabetes, angina, arthritis and high blood pressure. Although the ads do not mention the drugs by name, they prominently display Pfizer`s name in the hope that consumers who consult their doctor might request one of the manufacturer`s products for these conditions. My starting point is Wendy Mariner`s (1998) legal definition of consumers and patients. According to them, consumers are buyers of goods and services. Although patients have always been purchasers by paying for some, if not all, of their health care, they were not considered consumers until recently.

A patient is the recipient of a health service (Mariner, 1998). Some people use the term consumer to refer to the purchasing role (e.g., educating consumers about their health plan decisions). Other people use the term as a patient substitute because the latter term implies submission to medical professionals, although the consumer is not considered to play an economic role in this use. Once drugs were only available with a doctor`s prescription, pharmaceutical companies stopped advertising directly to patients and instead directed all their promotions to medical professionals. In the 1960s, more than 90% of pharmaceutical companies` marketing spending was directed to physicians (the rest was directed to pharmacists and hospitals), a complete reversal of the trend thirty years earlier (Hilts 2003). Now, the bulk of pharmaceutical advertising spending was spent on sales representatives called “retail men,” pharmaceutical sales reps visiting doctors` offices, and advertising in medical journals. Thus, federal regulations gave physicians authority not only over access to prescription drugs, but also over the dissemination of market information about drugs. The information they do not advertise, but undeniably the most important aspect, is the portion of their income that is used for research and development. A 2012 article in the British Medical Journal calculated that big pharma spends an average of 1.3% of their revenue on the development of new molecules, and that for every dollar spent on basic research, they spend $19 on marketing. While the distinction between the terms patient and consumer is often blurred, the differences between the legal rights of patients and consumers are clearer. While the right to information is at the heart of patient and consumer rights movements, the objectives of providing this information vary. Mariner (1998) argues that the primary tool of consumer protection laws is the disclosure of information to create a level playing field between buyers and sellers (Mariner, 1998).

Patients` rights have developed outside the context of commercial markets, independently of health insurance and regardless of the existence or source of payment for healthcare. Usually, a patient is in contact with a doctor or other health professional. Mariner (1998, 4) notes that after the Durham Humphrey amendments came into force, more drugs were sold by prescription but did not carry the full labelling of nonprescription drugs. Instead, the primary goal of the changes was to avoid self-diagnosis and self-administration of complex and potentially harmful drugs by patients (Kendellen 1985). In fact, FDA officials considered some drugs potentially so dangerous that no amount of information provided to consumers would make self-medication safe. Labelling would rather be aimed at pharmacists and doctors, who in turn would provide information to the patient. Thus, a paradoxical situation developed in which potentially dangerous prescription drugs were dispensed to consumers with less accompanying information than over-the-counter drugs (IOM 1979). The view of federal drug regulators that prescription requirements are an important means of protecting consumers coincided with the AMA`s long-standing goal of ensuring greater physician control over drug use (Starr, 1982; Temin, 1980).

In the late 1970s, the FDA proposed regulations that would eventually require PPIs for all prescription drugs, a measure opposed by the pharmaceutical industry because of the cost of the PPI program (Schmidt, 1985). In 1979, the agency published regulations mandating the use of ten classes of prescription drugs. In 1982, after the Reagan administration appointed a new commissioner to the FDA, it repealed the 1979 regulation in favor of a plan under which pharmaceutical companies would voluntarily share prescription drug information with consumers (Pines 1999). I begin my report on the federal regulation of drugs in the early twentieth century for two reasons. First, DTCA and other forms of pharmaceutical advertising are heavily regulated by the Food and Drug Administration because their power to regulate advertising is closely tied to its power to approve prescription drugs, the primary means by which the FDA ensures public health and safety in the use of drugs. Federal drug regulation began in 1906 and was expanded to include three major statutes between 1938 and 1962. Given that the changes in the way companies advertise drugs are closely linked to these regulators` expansions, they deserve a brief explanation. Second, DTCA`s criticism is that advertised products are only available by prescription. Although the promotion of over-the-counter drugs is widespread, it has not generated the same level of controversy as they are considered safe for consumers to use themselves. The modern distinction between over-the-counter and prescription drugs stemming from the legislation of the 1950s is therefore a crucial part of history. In 1976 and 1978, the FDA sponsored two symposia to gather feedback on the PPI concept from consumer groups, professional societies, pharmaceutical manufacturers, pharmacists` organizations, and other groups.

Two arguments were put forward in support of the PPI approach. The first is the safer and more effective use of drugs. The argument was that PEPs would help improve patient adherence and reduce drug interactions and adverse drug events by ensuring they use prescription drugs correctly.