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.”

“The world is badly in need of a comprehensive global strategy that unifies the efforts of all the stakeholders including governments, drug companies, health professionals, customers, civil societies, and judicial systems transnationally to combat poor quality drugs,” the editorial writes, asking, “Who will take the lead?” The editorial notes that both the Lancet and the IOM report have called on the WHO for leadership on this issue. The editorial concludes, “This IOM report provides a reference and instruction for WHO to continue to play an assertive central role in the fight against falsified and substandard drugs, within the context of public health and patient protection” (2/23).