Monitoring and evaluating a drug's safety becomes more complex after it is approved and marketed. Once on the market, a drug will be taken by many more patients than in the clinical trials and physicians are free to use it in different doses, different dosing regimens, different patient populations, and in other ways that they believe will benefit patients. This wider use expands the safety information about a drug. Adverse reactions that occur in fewer than 1 in 3,000 - 5,000 patients are unlikely to be detected in Phase I - III investigational clinical trials, and may be unknown at the time a drug is approved. These rare adverse reactions are more likely to be detected when large numbers of patients are exposed to a drug after it has been approved. Safety monitoring continues for the life of a drug. Post-marketing surveillance is a highly regulated and labor-intensive global activity. Even before a drug is approved, multinational pharmaceutical companies establish large global systems to track, investigate, evaluate, and report adverse drug reactions (ADRs) for that product on a continuing basis to regulatory authorities around the world.
Introduction
“Depression elicits Prozac, high cholesterol has made Lipitor a familiar name and hay fever sufferers are all familiar with Claritin”(Schroff, 2003). A once mysterious industry has now opened its doors to American consumers and prescription drug advertising has become a billion dollar business. From the multimillion-dollar Super Bowl ads to the repetitive spots that are shown during primetime sitcoms, advertising for branded prescription drugs abounds. Overall, the advent of prescription drug advertising has added an entirely new dimension to the role of consumers in the decision making process for prescription medications and consumers are now more informed than ever before (Smith, 1998).
In order to increase brand awareness for prescription medication, drug manufacturers spent $15.7 billion on promotions in 2001, of which $2.5 billion went to mass media advertising. Prescription drug advertising, often referred to as direct-to-consumer (DTC) advertising, has increased at an annual rate of 13-20 percent since 1997. Thus far, there have been mixed findings regarding the overall financial impact of DTC advertising on the pharmaceutical industry. While there is some evidence that suggests a direct and positive correlation between mass media advertising and drug manufacturers' earnings (Findlay, 2002; Anderson, 2003), the relationship between adverting expenditures and the success of specific brands is not clear. Clearly, drug manufacturers place a great deal of faith in DTC ads and the impact that they can have on consumers' decision to adopt advertised brands, but the exact nature of that impact remains controversial. While a recent study reports that for every 10 percent increase in DTC advertising, there is a 1 percent increase in drug sales (Kaiser Family Foundation, 2003), there is also evidence that DTC ...