Health Policy and Cardiovascular Medicine

Abstract

Our review of the approval and postmarket surveillance of new drug and biological therapies, generic drugs, and medical devices shows the range of the FDA's authorities and responsibilities and highlights areas of effective regulatory oversight, as well as some important limitations to the FDA's authority with direct implications for patient care. We have demonstrated that the FDA has numerous pathways that allow rapid authorization of promising new drugs and devices to address unmet medical needs and generally performs its functions as quickly as, if not more quickly than, its counterparts in other countries. However, the choice of approval pathway for both drugs and devices clearly affects the evidence generated to support FDA approval, information that should be clearly communicated to patients and physicians. In addition, postmarket surveillance remains a challenge with methodological and resource limitations. As the healthcare marketplace is confronted with new and innovative medical products such as mobile health devices, 3-dimensional printers, follow-on biologics, targeted gene therapies, and even medical marijuana, it will be important to learn from the FDA's past experiences in designing policies that optimize its ability to protect the public health.