FDA says its surveillance network exceeds goals

The Food and Drug Administration met its first major milestone for the number of patients covered under its Sentinel Initiative, an electronic surveillance network being developed to monitor the safety of FDA-approved drugs and medical products after they are released to the public, the agency announced in a new report.

By taking advantage of large federal databases of patients, FDA officials said they exceeded their goal of accessing health records for at least 25 million patients for Sentinel by July. FDA drew on databases held by the Defense, Health and Human Services, and Veterans Affairs departments to reach 60 million patients, the agency said in the report, which was published on its website Nov. 10.

“FDA met the July 2010 goal for access to patients’ electronic health care data and is already working towards the patient data access goal of 100 million patients by 2012,” the report states.

The report describes Sentinel as a distributed network that will draw on large databases of patient health care data to evaluate safety concerns regarding specific drugs or medical products. The patient data will continue to reside with its home agency — currently DOD, HHS or VA — rather than being collected in a central location.

GAO: FDA's tracking system isn't secure

FDA readies new data systems for drug safety

To start an investigation of a specific drug or medical product via the distributed system, FDA will generate questions that will develop analytical programs so the network partners can analyze their data and submit summary information in a format that meets federal privacy and security requirements under the Health Insurance Portability and Accountability Act.

FDA said the distributed model has inherent safety protections because personally identifiable data will not be transferred to FDA but will remain under the control of the partner agencies.

FDA referred to Sentinel as an active surveillance system because it allows the agency to start its own safety evaluations, with the added advantages of near-real-time data and the ability to target data. It complements FDA's passive post-approval drug and medical product surveillance systems to provide a more comprehensive means of monitoring safety, FDA officials said.

Because of Sentinel's complexity, FDA has developed several related pilot projects, including Mini-Sentinel, which is a smaller working model of the system, and the Federal Partners’ Collaboration, a partnership among DOD, HHS and VA to develop scientific methodologies to perform the evaluations for Sentinel, the report states.