communication efforts at FDA, discuss some of the challenges that have complicated those activities, and to suggest two specific areas for improvement and makes appropriate recommendations.

Pharmaceutical products constitute 11 percent of the health care dollar (Smith et al., 2005). They are characterized by complex risk-benefit profiles, long and complicated research processes, and high visibility. They have the potential to provide important health benefits, from reducing risk of death to improving quality of life, and they are subject to extensive regulatory oversight. Those are some of the reasons why effective and timely risk communication about drugs is essential.

Despite the greater role patients play in their own health care, and the health care delivery system’s recognition of that role, most of the communication “transactions” in the drug safety system occur among regulators, sponsors, providers, and payors. There are two types of information that may be communicated: information directed outward from stakeholders in the drug safety system (such as education, risk communication, promotional information), and information directed toward the drug safety system from those who experience drug safety problems directly or indirectly (including drug event reporting by patients or providers).

The Committee on the Assessment of the Drug Safety System did not endeavor to conduct a comprehensive examination of the communication needs of patients and the general public. Another IOM committee addressed these issues extensively in their report, Preventing Medication Errors (2007). That report recommended specific steps the health care delivery system, FDA, and other federal agencies could take to improve the availability, accessibility, quality, and quantity of patient and consumer information about drugs and their risks and benefits (see Box 6-1 and Appendix A). The present chapter focuses only on two areas where the committee believes FDA could strengthen its programs targeting patients’ and consumers’ communication needs.

Consumers and patients seek to access the information they need about the drugs they use through an incomplete and imperfect patchwork of sources (Brann and Anderson, 2002). These sources are of varying reliability and usefulness, and they include health care providers and pharmacists, DTC advertising, printed information made available by pharmacies, FDA-required patient package inserts for a limited number of drugs, information from a wide variety of sources made available on the Internet, and so