Public and private healthcare experts have been struggling for years to establish electronic health information systems able
to track and transfer a broad range of data in patient medical records. The inability of the nation's fragmented health IT
(HIT) systems to communicate with one another has made the task extremely difficult, as do concerns about patient privacy
and protecting access to personal health information (PHI).
The US Food and Drug Administration hopes that increased connectivity among healthcare entities will support more efficient
drug testing and development, along with more timely medical product monitoring and oversight. To take advantage of these
developments, the FDA is working to update its internal IT operations to improve its capacity for reviewing applications for
new drugs and medical products, for receiving and archiving clinical trial data and regulatory submissions, and for tracking
manufacturing facilities and product supply chains.
A main goal is to expand oversight of the safety of drugs and medical products on the market. To this end, the FDA is centralizing
adverse event analysis through an all-FDA adverse event (AE) reporting system and is creating a MedWatch Plus single portal
for public reporting of AE information. Work continues on a final rule requiring electronic filing of AE reports for drugs,
biologics, vaccines, and medical products, a mandate that smaller drug and biotech manufacturers fear will be costly and challenging.
Probably the most high-profile project involves establishing a proactive information system that can detect signals of adverse
events for regulated products. The aim, as specified in the FDA Amendments Act of 2007 (FDAAA), is to augment the agency's
passive AE reporting system with a more active program able to monitor health records on 100 million people by July 2012.
To meet this goal, FDA launched the Sentinel Initiative in 2008 and is now establishing a mini-Sentinel system that will tap
into medical records held by large health plans and insurers. FDA will pose questions triggered by risks seen in clinical
trials or by early AE reports to databases established by CIGNA, Kaiser Permanente, and the HMO Research Network, among others.
A second phase next year will broaden access to include data from Medicare and other government health programs.
To coordinate operations, FDA recently signed a $72 million contract with the Harvard Pilgrim Health Care system to implement
a distributed data model that can obtain near real-time signals and ensure data quality from appropriate sources. The system
permits FDA to ask Sentinel partners to monitor for certain events and to assess evidence of health conditions associated
with drug use. The program already can access information on 60 million patients, according to Project Director Richard Platt
of Harvard Pilgrim and Harvard Medical School. That's well above the 25 million patients that FDAAA instructs FDA to monitor
by July 1 of this year. Mini-Sentinel also will work with researchers and technical experts at academic centers, private firms,
and non-profit organizations to examine methods for querying against a common data model and to establish policies and standards
for validating and analyzing information from diverse information sources.
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 the importance of post-marketing
surveillance of regulated products. To have a fully functioning Sentinel system, she noted, we need to examine how to design
a common data model that can compare and analyze data sets, and to reach 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, described Sentinel as one element in a broader FDA
effort to encourage the safe use of medications, to revamp the agency's pharmacovigilance system and to explore the use of
social media to publicize safety problems. Sentinel is "very much a work in progress," Woodcock commented, noting that it
will be very different in five years as the science and technology mature.
The FDA's decision to launch Sentinel based on a distributed data model reflects earlier research by academic experts and
by the Observational Medical Outcomes Partnership (OMOP), an industry-funded collaboration involving the FDA, the Foundation
for the National Institutes of Health and the Pharmaceutical Research and Manufacturers of America. Through this partnership,
manufacturers are working to define viable approaches for assessing drug safety and for communicating those findings to health
professionals and patients.