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November 30, 2007
Open Source AEs
by Peter Pitts
Mark McClellan (“the hardest working man in American health care") told a gaggle of biotech executives at Lazard Capital Markets' 4th annual health care conference that a new bill passed by Congress will create a vast new database of drug patients by 2012.
McClellan said major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Wellpoint, Inc.and Unitedhealth Group to gather and collate the data from patients. This initiative is part of the FDA Amendment Act of 2007.
"Most of the evidence on your products will be coming from sources other than you," said McClellan, who sees the information as being more complete and more objective.
If all members of the American health care system can work together and following the same rules (in how they define adverse events and how they use the data) “you've got tens of millions (of people) in the database," said McClellan.
Posted by peterpitts at November 30, 2007 10:55 AM
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