turer or to FDA’s Adverse Event Reporting System (providers may report through the MedWatch portal). Although proposals have been made in the United States and Europe to mandate provider reporting, there is little evidence that such attempts would be successful. Furthermore, spontaneous reporting is only one component of an effective drug safety surveillance program, and should not be relied on as the sole or primary source of information. Finally, the quality of spontaneous reports is an important concern; a large quantity of incomplete and poorly executed reports would be unhelpful.

The frequently dangerous patent medicines that led to the Pure Food and Drugs Act of 1906 and the Food, Drug, and Cosmetic Act of 1938 were advertised directly to consumers with their colorful labels and claims, but modern prescription drugs, as products of biomedical science are promoted largely to health care providers, mostly to physicians. About 86 percent of industry promotional budgets still pay for “sampling” (providing free samples to providers), detailing (drug promotion to individual providers), and advertising in professional journals (Kaiser Family Foundation, 2004). However, the 1980s were a period of increased advertising directed at patients, known in some contexts as consumers—the term intended to reflect the changing role of patients to more active engagement with the health care system and involvement in their own health care.³ In 2005, pharmaceutical manufacturers spent an estimated $4.2 billion on DTC advertising (and $7.2 billion on professional promotion through journal advertising and sales representative contacts) (IMS Health, 2006). A more recent development in pharmaceutical promotion is relationship marketing, in which companies customize their promotional and informational efforts to target patients who have specific diseases, such as diabetics who use a specific product (Ahearne et al., 2005).

FDA faces a number of challenges in improving its internal and external communication. As noted in Chapters 1 and 3, CDER has recognized that its credibility can be compromised by adverse publicity with respect to drug