All pharmaceutical products have inherent risks, and their use involves trade-offs between these risks and their therapeutic benefits. However, the public has a limited understanding of this trade-off, and many individuals believe that drugs approved by the Food and Drug Administration carry no risks. Assessing, managing, and communicating the benefit–risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop, entitled Understanding the Benefits and Risks of Pharmaceuticals. Its broad goals were to gain a better understanding of the current system used to evaluate benefit and risk and to identify opportunities for improvement.

Discussions during the workshop focused on

• premarket assessment, during which clinical trial data are used to assess benefit and risk;
• communication of that information to prescribing physicians and their patients;
• healthcare decisions made by prescribing physicians and their patients; and,
•  the accumulation and assessment of benefit–risk information gained from postmarketing experience.