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The Future of Drug Safety: Promoting and Protecting the Health of the Public
standing of disparities in health status and the development of appropriate means of communicating useful therapeutic and health care information to heterogeneous populations.
The science and technology that underpin drug discovery are in a process of dramatic transformation. Advances in the basic sciences have increased the number of targeted drugs, and technological advances promise to transform and expand the array of drugs available for the prevention and treatment of human disease (Gwynne and Heebner, 2001; Cockburn, 2004). Technologic and scientific developments also promise to enhance the prediction of safety problems and opportunities earlier in the development process, but much more work is needed to actualize these promises (FDA, 2004).
The practice of drug discovery and drug development research has also changed substantially in response to scientific and technological advances. Drug discovery research is funded by both industry and government, and takes place in academe, government—especially the National Institutes of Health (NIH)—and industry. Almost all drug development occurs in industry, but an increasing proportion of industry-funded studies is being conducted outside academic health centers by contract research organizations, and more clinical trials are being conducted abroad (Cockburn, 2004). Biomedical research accounts for 5.6 percent of health expenditures in the US, with 57 percent of the research is funded by industry, and 28 percent by NIH (Moses et al., 2005). Despite advances, the development of new pharmaceutical problems is facing challenges—in its Critical Path report (FDA, 2004), FDA asserted that the translation from the basic sciences of drug discovery to the applied sciences of drug development has become sluggish because “the development path is becoming increasingly challenging, inefficient, and costly.”
The practice of medicine and the provider-patient interaction—the point where the pharmaceutical product traditionally “meets” the patient—also have undergone great transformation in the last two or three decades. First, use of prescription drugs has been increasing steadily (Ganslaw, 2005). Physicians and other health care providers have more therapeutic options at their disposal, and both polypharmacy2 and the chronic use of drugs have become extremely common, especially in the rapidly growing segment of the population in late middle age and older. Use of drugs to treat chronic disease risk factors such as high blood pressure and high cholesterol has expanded immensely. Second, the role of the patient has changed as part of the larger shift toward consumer empowerment in the private sector. The health care system (like other sectors) places increased emphasis on consumer choice.
The administration of multiple drugs concurrently, with the concomitant increased risk of drug interactions.