FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest

There have been long-standing concerns regarding the Food and Drug Admin.'s (FDA) oversight of postmarket drug safety. There were concerns such as limitations in the data FDA relies on to identify postmarket drug safety issues and the systems it uses to track such issues. Recommendations were made, including that FDA improve the independence of its program for resolving scientific disputes related to postmarket drug safety. This report examines the steps that FDA is taking to: (1) enhance its processes for making decisions about the safety of marketed drugs; (2) improve access to data that help the agency identify drug safety issues; and (3) build its capacity to fulfill its postmarket drug safety workload. Includes recomm. Illus.

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

This book challenges the convention that government bureaucrats seek secrecy and demonstrates how participatory bureaucracy manages the tension between bureaucratic administration and democratic accountability.

Reviews the FDA¿s strategic planning and mgmt. Leading practices in this area include developing strategies to address mgmt. challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance info. The report examined the extent to which: (1) FDA's Strategic Action Plan contains strategies to address its mgmt. challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance info. in decision making and applying key practices to encourage that use. Illustrations.