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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
Oregon Health and Science University, where investigators are developing new informatics capabilities to partner with Kaiser Permanente, the Northwest Center for Health Research, the Oregon Rural Practice Research Network, and the Portland VA Medical Center;
University of California-Davis, where new community research centers are being developed to expand efforts addressing minority and medically underserved populations; and
University of Pennsylvania, where robust efforts in cancer bioinformatics (CA BIG) are being led by the National Cancer Institute to improve the informatics capacity to report adverse events.
In addition to the partnerships cited above, NIH CTSA teams are being created to support efforts to develop new informatics capabilities. Additionally, the CTSA program has developed robust working relationships with the FDA and CMS. Updated information on the program is available at the CTSA website (http://ctsaweb.org).
Dr. McClellan summarized the discussion of a public–private partnership for the development of a national active surveillance network to monitor drug safety. He stated that it is “an issue whose time has come because . . . there is uniform agreement that this approach is feasible . . . and FDA reform is front and center in the legislative agenda and in the public agenda.” He cited interest at the highest levels within the Department of Health and Human Services in building a much more interoperative electronically based health care system, and suggested that creating a public–private postmarket drug safety monitoring system linking multiple existing databases is a leading edge of that effort.