FOR IMMEDIATE RELEASE                    Contact: Adriana Surfas
Thursday, May 22, 2008                           (202) 225-3661     

DeLauro Statement on the FDA’s Sentinel Program

Washington , D.C. – Congresswoman Rosa L. DeLauro (CT-3) issued the following statement on the announcement by Health and Human Services Secretary Michael O. Leavitt that the Food and Drug Administration will begin to develop the Sentinel Initiative, which is aimed at identifying post-market adverse events. 

The delayed initiative is in response to a 2005 directive from the HHS Secretary asking FDA to expand its efforts to monitor medical product performance.  Additionally, in 2006, the Institute of Medicine issued a report recommending that the FDA identify ways to access other health-related databases and create a public private partnership to support safety and efficacy studies.

“I commend the FDA for finally beginning to lay the groundwork to create a system that would allow for the sharing of medical product safety information.  However, it is troubling that this effort has taken so long, given that it originated from a 2005 Health and Human Services directive. It must also be noted that today’s announcement is only for the initial planning and analysis for the initiative – not for the actual implementation. 

“While this seems to be a positive step forward, we need to be implementing initiatives that will strengthen our drug safety efforts.”

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www.house.gov/delauro