ABSTRACT
As noted in the Institute of Medicine report on the Future of Drug Safety (Burke et al. 2006):
“Every day the Food and Drug Administration (FDA) works to balance expeditious access to drugs with concerns for safety, consonant with its mission to protect and advance the public health. The task is all the more complex given the vast diversity of patients and how they respond to drugs, the conditions being treated, and the range of pharmaceutical products and supplements patients use. Reviewers in the Center for Drug Evaluation and Research (CDER) at the FDA must weigh the information available about a drug’s risk and benefit, make decisions in the context of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. These processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population. The distinction between individual and population is important because it reflects complex determinations that FDA must make when a drug that is life-saving for a specific patient may pose substantial risk when viewed from a population health perspective. In a physicians office, the patient and the provider make decisions about the risk and benefits of a given drug for that patient, whereas FDA has to assess risks and benefits with a view toward their effects on the population. The agency has made great efforts to balance the need for expeditious approvals with great attention to safety, as reflected in its mission to protect and advance the health of the public.”
