Quality of care also has become a major issue for consumers. Pharmaceutical and health plan offerings are promoted to consumers now empowered to be decision-makers. Patients have unprecedented access to information about drugs, their benefits, and side effects. This is due in part to changes in the information environment. Promotion of drugs to patients has increased, including broadcast direct-to-consumer advertising. Access to the Internet has become widespread; this powerful tool provides access to information that varies greatly in accuracy, quality, and completeness (Tatsioni et al., 2003). The relationship between patients and their physicians has changed as patients have become more engaged and knowledgeable. Third, a category of “lifestyle” drugs has arrived in the marketplace. Two decades ago, patients used drugs chronically for treatment for and control of serious diseases. Today, many fundamentally healthy people take drugs long-term for purposes ranging from cosmetic improvement (such as botox) to symptomatic management (such as antihistamines) to performance enhancement (such as erectile dysfunction). For people who need to take drugs for control or treatment of serious diseases, the potential of adverse drug effects may be of less concern than it is for people who take drugs for very minor issues (see Box 1-1 for some FDA milestones).

Defining and Meeting the Charge

The Charge

Given the changes outlined above and in response to growing public concern with health risks posed by prescription drugs, FDA requested that the Institute of Medicine (IOM) convene an ad hoc committee of experts to conduct an independent assessment of the current system for evaluating and ensuring drug safety and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs (see Box 1-2). In recognition of their roles in the drug safety system, the Centers for Medicare and Medicaid Services (CMS), the Agency for Healthcare Research and Quality (AHRQ), NIH, and the Department of Veterans Affairs are also sponsors of the report.

In responding to the charge, the committee focused much of its attention on FDA’s CDER. Although the report is addressed to the FDA as a whole, a considerable proportion of the committee’s discussion and recommendations pertain to CDER’s structure, organization, and scientific and regulatory activities. Given the study timeframe, the committee found it difficult to accord the same level of attention (in terms of a detailed assessment and recommendations) to all other important stakeholders in the drug safety system. The roles of industry, the health care delivery system, and health care

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