Medicare to share data with FDA

Medicare and the Food and Drug Administration have announced a joint venture that promises to improve prescription drug safety and potentially reduce wasteful spending on medications.

The agencies said Thursday they have agreed on rules for using information from Medicare's giant claims databases to create a computerized early warning network for problems with medications and medical devices that come to light after they go on the market.

Medicare will not turn over individual patient data to the FDA, but the two agencies' computers will be able to "talk" to each other, to pose and answer questions that may reveal potentially risky side effects in new drugs. Since pre-market testing usually involves a limited number of patients, serious problems sometimes become evident only after hundreds of thousands of people begin using a product.

The system, called the Sentinel Initiative, will eventually include private insurers as well - to fill in information gaps about drugs that the elderly don't use, such as contraceptives.The FDA's current early warning system relies on self-reporting by drugmakers, hospitals and doctors and is believed to capture only between 1 percent and 10 percent of problems.

Privacy advocates are expected to scrutinize the new rules.