FDA Plans Near-Instantaneous Sentinel for Safety of Drugs and Devices

By Michael Smith
WASHINGTON, 23 may 2008-- The FDA revealed plans today to develop a system that will allow nearly real-time monitoring of drug and device safety.
The so-called Sentinel initiative will permit "proactive surveillance of medical products on the market," Mike Leavitt, the secretary of Health and Human Services, said at a press conference.
The initiative is a response to last year's Food and Drug Administration Amendments Act, which called for active post-market surveillance of medical products.
The idea is to link both public and private medical databases -- starting with the Medicare and Medicaid system -- so that it's possible to follow adverse events almost as they happen.
Andrew C. von Eschenbach, M.D., the FDA Commissioner, said the system will mean "we will no longer have to wait years to see how a drug or medical device is affecting millions of people. The era of 'wait and see' is going to become the era of 'tell me right now.'"
Dr. von Eschenbach added, "The sentinel system will give us an unprecedented ability to detect problems as they first begin to surface."
In a technical briefing after the press conference, FDA officials said the cost of the plan will not be large because there's no thought of building an expensive new information technology system.
Instead, the FDA will collaborate with owners of data -- both public and private -- and work out ways to query their databases, according to Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research.
The actual data mining would take place "behind the firewall of each organization," Dr. Woodcock said, and the results would be sent back to the FDA.
But Dr. Woodcock gave no concrete estimate of the cost of the initiative, although she said that more staff would be needed and the FDA is currently hiring.
The first agency to sign on is the Centers for Medicare & Medicaid Services (CMS), whose database is especially important because the agency's clients consume most of the prescription drugs in America, according to CMS Acting Administrator Kerry Weems.
Using CMS data, for instance, would allow the FDA to track adverse events associated with annual flu vaccinations by comparing immunization records with hospitalizations and other drug prescriptions, said Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research.
Such an approach could be much faster than waiting for local doctors and healthcare providers to notice adverse events and make reports, Dr. Goodman said.