FDA chooses organizations to monitor drug safety and effectiveness
The Food and Drug Administration (FDA) has selected four key organizations to help evaluate the safety and effectiveness of drugs used in the nation's nursing homes, hospitals and by the general public.
The groups are: http://www.unitedhealthgroup.com/ UnitedHealth Group through its Eden Prairie, MN-based Ingenix division; the http://www.dor.kaiser.org/resources/irb/irb-01.shtml Kaiser Foundation Research Institute, Oakland, CA; http://www.vanderbilt.edu/ Vanderbilt University, Nashville; and http://www.harvardpilgrim.org/ Harvard Pilgrim Health Care, Wellesley, MA. They will asssist the FDA by sifting through large computerized volumes of patient records.
Each organization will receive as much as $1.4 million from the FDA over the next five years.
The FDA plans to use the information in those files to conduct drug safety analyses and "respond expeditiously to urgent public safety concerns," according to agency officials. The new surveillance system, which will keep individuals' information confidential, will allow for a more timely response to signs of problems with particular drugs, officials said.