We appreciate the interest in our paper. Please know that our focus on health policy evaluations in the USA does not imply a lack of interest in international research efforts. Rather, we were tasked with evaluating the US Food and Drug Administration’s (FDA) regulatory actions and, hence, constrained from conducting a worldwide review of activities. We applaud Dr Mol’s work using rigorous designs to evaluate similar efforts in other countries. Evidence-informed health policy requires the same high methodological rigor as any healthcare intervention including robust study designs and methods that can produce trustworthy conclusions about effectiveness and costs. The necessary reliance on nonrandomized studies in most health policy evaluations means the potential for bias is great so even greater vigilance is needed.1 Evaluations of health policies are still uncommon and often conducted using weak study designs (e.g., uncontrolled, pre-post and cross-sectional) that are susceptible to biased conclusions. This is a global problem.