FDA's Role in Risk Management and Communication
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Food and Drug Administration
FDA is charged with assuring safety of the food, medical and veterinary products that the Agency regulates. Given that none of these products is 100% safe under all circumstances, safety may be operationally defined as "having risks that are reasonable, given the expected benefits." In balancing benefits and risks, FDA must acknowledge that safety is not an innate property of any product; rather, it is dependent on appropriate handling by the users. FDA risk assessments must include an evaluation of the capacity of users to act in ways that minimize risk; the willingness of recipients to assure risk and the weight they put on the risks; and the ability of "the system" to effectively communicate both risk information and risk management steps to the public. Understanding these issues requires extensive communication with product users. Interaction with the public, including consumer and patient involvement in decision-making, public educational campaigns, traditional risk communication, and provision of public information, is an increasing component of FDA risk management strategies.