This Lancet editorial notes the release of an Institute of Medicine (IOM) report commissioned by the Food and Drug Administration (FDA) that gathers information on "the global threat of falsified or substandard drugs" and provides recommendations "to mitigate this public health problem." According to the editorial, "The IOM report recognizes that the absence of a precise and internationally agreed definition to frame the problems of poor quality drugs is the major obstacle to advancing a global discourse," and recognizes "[a]nother barrier [as] the lack of rigorous research and robust data to accurately estimate the global burden of falsified and substandard drugs."