US health officials have launched a new system, called the Sentinel Initiative, which it is hoped will help the Food and Drug Administration detect early signs of emerging safety problems for marketed treatments.
In a white paper released by the FDA, the agency describes plans for the initiative, which will include the development of a new electronic system that will enable it “to query a broad array of information to identify possible post-market adverse events”. Sentinel will be created through public-private partnerships “and will capitalise on existing large electronic claims and medical records data sources”.
Specifically it is now possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D), “subject to protections for beneficiary privacy and commercially sensitive data”, for public health and safety research, “quality initiatives, care coordination and other research and analysis”.
US Health and Human Services Secretary Michael Leavitt said “this initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market”. He added that “we are moving from reactive dependence on voluntary reporting of safety concerns – to proactive surveillance of medical products on the market”.
FDA Commissioner Andrew von Eschenbach said that with the Sentinel System “we will no longer have to wait years to see how a drug or medical device is affecting millions of people”. He went to claim that “the era of ‘wait and see’ is going to become the era of ‘tell me right now’,” adding that “we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”
The FDA stressed that it would not have access to any of the personal information on Medicare beneficiaries. The initiative has been in the pipeline since 2005, when Mr Leavitt asked the agency to explore the creation of such a system. In 2006, the Institute of Medicine recommended the idea, and last autumn Congress voted to back Sentinel.
