Health officials in the U.S. announced plans for a new computer tracking system designed to help identify dangers from prescription drugs and medical devices on the market.

With the "Sentinel System," the Food and Drug Administration can search various databases for possible signs of side effects. The databases will include the government's Medicare health insurance plan. It is designed to use better tracking methods to catch risks that emerge after wider use in the marketplace versus a smaller clinical trial.

The FDA currently depends mostly on reports of potential side effects from manufacturers, doctors and consumers. Many cases are under-reported, because only manufacturers are required to submit them to the agency. Physicians and patients can volunteer the information to the agency.

Under the proposal, the FDA could search claims data from private health insurers, hospitals and Medicare to see if problems have occurred in patients given a particular treatment. This has been done on a limited basis by the FDA.

The FDA will start this plan by looking at information from more than 25 million patients with prescription drug coverage under Medicare. This data will not include patient names, and will also be available to states and academic researchers according to health officials.

Diana Zuckerman, president of the National Research Center for Women & Families, said the Medicare data could provide valuable insight into sick and elderly patients who are typically excluded from drug company clinical trials.

She said questions remained about how the FDA would use the data, how much funding would be available and which findings would be made public.

The system helps fulfill requirements set forth by Congress last year to strengthen the agency's oversight and was first proposed by the Institute of Medicine in 2006.

More Industry Headlines