Harvard Pilgrim Health Care has won a contract from the FDA to set up a prototype of a national monitoring system for drug and device safety that will collect automated data from providers and insurers.
Harvard Pilgrim Health Care Inc. will develop a prototype of the Food and Drug Administration’s Sentinel national drug safety monitoring system under a contract potentially worth $72 million over five years.
The FDA monitors adverse events from the use of medical drugs, products or devices through the use of reports filed by hospitals, doctors and industry members.
The Sentinel system, once operational, will provide access to more timely and complete information from a greater variety of sources, including doctor and hospital electronic record systems, insurance and administrative claims databases, and medical registries.
Under the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled-down version of the Sentinel System. The center “will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality,” FDA officials said in a news release dated Jan. 8.
To protect personal information, only summary data will be sent to the coordinating center. The data itself will remain within its original database.
"The award of this contract to Harvard Pilgrim to develop a medical product safety monitoring system is an important step forward for FDA's drug and medical device safety efforts," FDA Commissioner Margaret Hamburg said in the statement.
The FDA has been developing Sentinel since 2007 to fulfill some of the requirements of the FDA Amendments Act and has already awarded 10 Sentinel contracts. Those previously awarded small contracts address scientific operations, data and infrastructure, privacy, and stakeholder engagement. The FDA also has a cooperative agreement with the Brookings Institution to convene meetings and workgroups on medical product surveillance issues.
The Government Accountability Office, in a recent review of Sentinel, recommended improvement of the programs to ensure patient privacy.
The FDA also is implementing two other drug safety systems this year, MedWatchPlus, to improve the collection and processing of reports, and the FDA Adverse Event Reporting System, which will receive the reports and store them in a single location.