FDA, CMS e-tracking initiative portends new era of device, drug safety

HHS Secretary Mike Leavitt shakes hand of FDA Commissioner Andrew C. von Eschenbach. Source: HHS

New electronic tracking initiatives by the government will move it from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market.

The Sentinel Initiative, announced in a white paper released May 22 will enable the FDA to electronically query a broad array of information to identify possible post-market adverse events.

The Sentinel System will be created through public-private partnerships and will capitalize on existing electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort, according to the agency.

A final regulation from the Centers for Medicare and Medicaid Services, also published May 22, will make it 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.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Michael Leavitt, secretary of Health and Human Services. CMS said that the Sentinel System is an important example of how EHRs and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality healthcare.

“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,” said FDA Commissioner Andrew C. von Eschenbach, MD. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, 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,” he said.

The FDA report is available online.