The US Food and Drug Administration Cardiorenal Advisory Panel and the Drug Approval Process

Abstract

New chemical entities developed by the pharmaceutical industry as potentially useful drugs undergo extensive preclinical evaluation followed by clinical trials to evaluate efficacy and safety in human subjects. In the United States, the Food and Drug Administration (FDA) is charged with evaluating requests from pharmaceutical sponsors for approval to market new drugs or to expand indications for marketed drugs. Some of these decisions are relatively straightforward. Thus, a new drug that shows clear efficacy and little actual or theoretical risk for serious adverse effects and that represents a significant addition to the therapeutic armamentarium does not present a major problem for FDA regulators. Conversely, approval will not be granted for a new drug the efficacy of which cannot be demonstrated, a drug with serious adverse effects that are not shared by alternative treatments, and a drug that does not add importantly to available treatment in at least some patients. In many cases, however, efficacy may not be so clear-cut, risks may be (or may appear to be) more than minimal, and the pharmaceutical sponsor and the FDA may differ in their evaluation of each of these issues. In such cases, the FDA through its Center for Drug Evaluation and Research (CDER) has since 1972 been able to call on panels of experts to provide advice. For cardiovascular drugs, this advice is offered by the Cardiovascular and Renal Drugs Advisory Committee (CRAC). The goal of this article is to summarize how the deliberations of this committee have affected not only individual new drug submissions but also more generally the way in which new drugs are developed and evaluated. Advisory committees do not actually “decide” whether drugs should be approved; rather, they provide advice to the FDA, where the final decisions with regard to drug approval rest. The FDA is not obliged …