FDA Unveils Plan to Track Safety of Drugs, Medical Devices Already Sold

By Linda Richwine and | June 2, 2008

U.S. health officials announced plans on May 22 for a new computer tracking system designed to help them identify dangers from prescription drugs and medical devices already on the market.

The system would enable the Food and Drug Administration to search various databases for possible signs of side effects. The databases include that of the government’s Medicare health insurance plan for the elderly and disabled.

The FDA’s safety monitoring has been criticized as inadequate and slow, especially after Merck & Co Inc.’s 2004 withdrawal of painkiller Vioxx because of increased risk of heart attacks and strokes.

“We’re moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market,” Health and Human Services Secretary Mike Leavitt told reporters.

Called the Sentinel System, the new effort is designed to better track risks that emerge after wider use in the marketplace versus a smaller clinical trial. “We also will learn things that will lead to new warnings, absolutely,” said Dr. Janet Woodcock, head of the FDA’s drugs division.

The FDA currently relies largely on reports of potential side effects from manufacturers, doctors and consumers. 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. The agency has done that on a limited basis.

“The FDA will eventually be able to query databases of tens of millions of patients almost simultaneously. It will no longer have to wait for reports to trickle in from the field,” Leavitt said.

It was not clear how long it would take officials to set up the program. The FDA plans to start by looking at information from more than 25 million patients with prescription drug coverage under Medicare. That data, which would not include patient names, would also be available to states and academic researchers, health officials said.

Consumer groups welcomed the plan as an improvement over current monitoring but said it was unclear when it would yield benefits, given the FDA’s strained budget and staff.

Useful information from Medicare patients could be available within a year, Findlay estimated, while other efforts would likely take longer.

The Pharmaceutical Research and Manufacturers of America, an industry group, said the effort “should improve the efficiency of post-market surveillance” and benefit patients.

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.

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