Harvard Pilgrim Health Care Inc. has won a major grant from the Food and Drug Administration to build a system to monitor the safety of drugs and medical devices after they have gone on the market.
Pilgrim will use a five-year, $72 million grant to coordinate the efforts of 28 health care organizations around the country as they design ways to make use of information they already gather, in electronic medical records or claims data, to provide early warning of potential harm.
“The goal is to be able to do active surveillance, to look for signals that might indicate there is a safety problem and then to be able to follow up to determine whether there is a problem or not,’’ said Dr. Richard Platt, who will lead the effort. He is chairman of population medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. “This is part of a major shift on FDA’s part from being reactive, waiting for physicians and patients to tell them about problems, rather than to be looking actively for problems.’’
