. "Appendix C: Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II." A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press, 2011.
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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
VACCINES RISK MANAGEMENT – Many vaccines provide critical public health benefits, so that significant disruptions or interruptions in supply may have broad consequences for public health. Suppliers, supplies, and production capacity of some important vaccines are limited. Whenever concerns arise about manufacturing processes, decisions for action must weigh the relative potential consequences for safety versus the potential consequences of decreased availability. Loss of public confidence in these products and any resulting reduction in inoculation rates represents a potentially serious public health hazard. What measures of public health impacts should be taken into account in making decisions about safety interventions and/or risk management strategies, and setting priorities for action? What information is needed to support such decisions?
DRUG MANUFACTURING SURVEILLANCE (1) – FDA must decide how to apportion resources between surveillance of manufacturers of normally safe, over-the-counter children’s cough medicine and manufacturers of a narrow therapeutic range, sterile-injectable product. The former has a nonzero risk of economically-motivated adulteration with a potentially lethal sweetener. How can we take all relevant public health impacts into account in making such decisions about surveillance priorities and risk management strategies in this scenario? What data would inform such decisions?
DRUG MANUFACTURING SURVEILLANCE (2) – In allocating inspection resources, FDA must choose between engaging in a domestic drug surveillance inspection designated as high-risk by the Center versus a foreign drug inspection. What measures of public health risks and benefits should be taken into account in making decisions about drug inspection priorities, and what analyses could support such decisions? What data would inform such decisions?
UNPLANNED EMERGENCY ACTIVITY VERSUS HIGH-PRIORITY PLANNED INSPECTIONS – In order to accomplish two Class 1 (significant health hazard) recalls on firms that required full follow-up, FDA had to pull resources from surveillance of high-risk firms, thus jeopardizing accomplishing the targets set by the Center for surveillance of high-risk firms. Similarly, in the midst of a risk-based assignment for a Center, FDA requested four recalls; we had to marshal our workforce to address this massive undertaking. How should we analyze these situations to better understand the full array of public health impacts of these decisions? What data is needed for such analyses?
SETTING PRIORITIES FOR LIMITED INVESTIGATIONAL RESOURCES – An animal producer with multiple drug residue violations appears to have another violation before FDA has finished investigating the previous ones. This occurs in part because other higher priority food borne illness investigations or performance goal work take precedence in tapping the same human resources. What risks and benefits should be considered in analyzing the comparative public health impacts of follow-up violations versus other work, and how might they be compared? What data would inform such analyses?