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U.S. Creates Drug and Medical Device Surveillance System

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The U.S. government will establish a surveillance system to help monitor the safety of drugs and other medical products on the market.

The system will analyze Medicare claims data for signs of problems with medicines and medical devices. On Thursday, the U.S. Health and Human Services Department introduced a plan to allow federal agencies, states, and academic researchers to examine Medicare claims data. That access will be subject to protections for privacy and trade secrets.

The system would enable the U.S. Food and Drug Administration to analyze significantly more information than it can today by tapping into databases of health information to detect early signs of emerging safety problems.

This kind of surveillance system was recommended in 2006 by the Institute of Medicine, and the FDA has been under pressure to implement such a system, the Associated Press reported.

"This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market," HHS Secretary Mike Leavitt said in a prepared statement.

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