The legislation also strengthens privacy and disclosure requirements to enhance public trust in EHR programs. In the process, though, it threatens to restrict the services that pharma marketers and other third parties can offer healthcare plans and providers, such as medication reminders and disease management.Active Surveillance
Increased connectivity among healthcare entities promises to affect more efficient drug testing and development, along with more timely medical product monitoring and oversight. To take advantage of these developments, FDA is updating internal IT operations, partly in response to a 2007 report from the FDA Science Board describing the sorry state of the agency's IT infrastructure.
One goal is to provide information on the safety of regulated products more quickly. To this end, FDA is centralizing adverse event (AE) analysis through an all-FDA Adverse Event Reporting Systems (FAERS), and is creating a MedWatch Plus single portal for public AE reporting. Probably the most high profile project is to establish a proactive electronic information system able to monitor health records on 100 million people by July 2012, as required by the FDA Amendments Act of 2007 (FDAAA).
To meet this deadline, FDA launched the Sentinel Initiative in 2008, and now is establishing a "mini-Sentinel" system that will tap into medical records held by large health plans and insurers to monitor for certain events and assess evidence of health conditions associated with drug use. FDA recently signed a $72 million contract with the Harvard Pilgrim Health Care system to implement a distributed data model that will enable FDA to query databases established by CIGNA, Kaiser Permanente, and the HMO Research Network, among others. The initiative already has access to information on 60 million patients, according to project director Richard Platt of Harvard Pilgrim and Harvard Medical School. That's well above the initial FDAAA requirement of 25 million patients by July 1, 2010. A second phase next year will permit direct FDA access to de-identified health records from Medicare and other government health programs.
Platt and others discussed the technical, legal, and administrative issues involved in building the Sentinel System at a January workshop organized by Mark McClellan, former FDA commissioner and now director of the Engelberg Center for Health Care Reform at the Brookings Institution. FDA commissioner Margaret Hamburg opened the conference by emphasizing her support for better postmarketing surveillance of regulated products. To have a fully functioning Sentinel System, she urged consensus on methodologies for proving and disproving causal relationships between a product and an outcome.
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), described Sentinel as one element in a broader FDA effort to encourage safe use of medications, revamp the agency's pharmacovigilance system, explore the use of social media to publicize safety issues, and better understand drug effects in different populations through worldwide collaborations. Sentinel is "very much a work in progress," Woodcock commented.