. "Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States." The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press, 2007.
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The Future of Drug Safety: Promoting and Protecting the Health of the Public
PROGRAM REVIEWS OR EVALUATIONS
In May 2006, CDER announced that it was launching an internal assessment of its Advisory Committee meeting system to establish best practices surrounding that process. The assessment will be led by senior management in CDER and will take a comprehensive look at current practices for nominating committee members, screening for conflicts of interest, choosing expertise for specific meeting topics, and utilizing Special Government Employees.
Postmarketing Study Commitments
In April 2006, FDA contracted with Booz Allen Hamilton for an evaluation of FDA’s postmarket study process (phase IV commitments) for collecting medical information (FDA Press Release, 2006). The evaluation will comment on how FDA can increase consistency in requesting, facilitating, and reviewing postmarketing commitments among centers. Ultimately, this will help FDA to request focused studies that result in the information needed to assess safety postmarket.
In August 2005, FDA and the Association of American Medical Colleges (AAMC) released the joint report Drug Development Science Obstacles andOpportunities for Collaborations, which describes an array of opportunities for scientific breakthroughs to be undertaken through collaboration to reach the goals of CPI (AAMC, 2006; AAMC et al., 2005; DeClaire, 2005). The report states that those partnerships should focus on greater sharing of knowledge, regulatory and legislative relief, earlier evaluation of drugs in humans, and improved education and training for health professionals. Some of the kinds of collaboration outlined in the report are to develop mechanisms to learn from failed drug targets, establish joint models for biomarker validation, set up a consortium to analyze and learn from failed clinical trials, and develop agreements for sharing of information restricted as intellectual property.
In November 2005, FDA, the European Commission, and the European Medicines Agency extended by 5 years a confidentiality agreement that began in September 2003 (FDA and EMEA, 2004; DeClaire, 2005; FDA et al., 2005). The types of information covered by the agreement are legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures, and postmarketing surveil-