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Statement by Steven Galson, CDER Director, Regarding The Institute of Medicine's
In early 2005, FDA asked the Institute of Medicine (IOM) to conduct a study covering the agency and the U.S. drug safety system. On Friday, an uncorrected prepublication version of the report was released. http://www.iom.edu/CMS/3793/26341/37329.aspx. FDA has recommended some technical corrections to IOM, and IOM will issue a final report. Also on Friday, Dr. von Eschenbach issued the statement at the following link: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01461.html The report contains some 25 recommendations that cover our resources, authorities, processes, science and organizational culture. The recommendations are directed to Congress, the Department of Health and Human Services (HHS) and the Agency, and our specific reactions to each one will require extensive discussion. I believe the IOM report offers a significant opportunity for CDER to reexamine how we address drug safety. The spirit of the report resonates with many of us, even if some have questions regarding specific recommendations put forward by the IOM. I also see the report as a call to action for the broader community to work with us to address the tools, resources, and approaches we use in improving drug safety. CDER has worked hard over the past few years on many aspects of drug safety, including efforts to improve communication, enhance our collaboration on drug safety issues, provide oversight, and improve our scientific partnerships and information infrastructure. I am very proud of these efforts and appreciative of the time many of you have invested in them. Details of these efforts are summarized in a fact sheet posted on Friday: http://www.fda.gov/oc/factsheets/initiative.html I look forward to working with you as we take on the challenge of these recommendations. Steven Galson
Date created: September 26, 2006 |
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