HHS starts new drug, device safety program

May 23, 2008 at 12:13 PM
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WASHINGTON, May 23 (UPI) -- U.S. health officials said a new program to analyze medical records should mean quicker identification of safety issues with drugs and medical devices.

The Food and Drug Administration's Sentinel Initiative will allow the FDA and other agencies to analyze databases containing millions of health records to try to recognize problems more quickly than the current system allows, The Washington Post reported Friday. The current system relies mainly on voluntary reporting by individual physicians.

The FDA has been harshly criticized in recent years for safety issues with prescription drugs such as the painkiller Vioxx, withdrawn from the market in 2004 after researchers found it caused heart attacks.

"It will be a quantum leap forward in the FDA's capacity to monitor the use of medical products that are currently on the market," Health and Human Services Secretary Mike Leavitt said.

HHS will kick off the program by analyzing data about the 5 million-plus people enrolled in the Medicare prescription drug program, Leavitt said. State agencies and academic researchers also can access the data under a federal regulation that is effective in 30 days, officials said.

Patient privacy would be maintained by keeping all identifying information confidential, officials said.

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