FDA has been laying the foundation for the Sentinel System for years through contracts and partnerships with healthcare "data
owners" that permit queries to electronic health records and claims databases on specific drug safety issues. For example,
the agency contracts with UnitedHealth Group's Ingenix, Vanderbilt University, the Kaiser Foundation Research Institute, and
Harvard Pilgrim Health Care to access pharmacoepidemiologic information that can test hypotheses arising from AE reports.
CBER works with the Centers for Disease Control and Prevention (CDC), the Veterans Health Administration (VHA), the Centers
for Medicare and Medicaid Services (CMS), and large healthcare plans to monitor use of influenza vaccine and related outcomes.
Several projects with the Agency for Healthcare Research and Quality (AHRQ) are currently assessing the use of distributed
networks for comparative effectiveness and safety studies.
A new CMS policy gives FDA access to millions of pharmacy claims submitted by Medicare Part D drug plans [see "Leading Indicators/News,"
July 2008]. With additional funds to support postmarket surveillance, FDA plans to expand access to CMS, VHA, and health plan
databases, further expanding its ability to detect and assess adverse events related to marketed drugs.
Shaping the system
FDA and its partners are beginning to map strategies for how this network will operate. A charter will define which entities
can join the partnership, what data sources will be used, what queries can be run on the system, who can pose queries, how
specific evaluations will be paid for, how results will be communicated, and how privacy protection will be ensured. Most
likely, a nonprofit network "convener" will channel queries to the partnership and oversee distribution of results.
Network partners will also research best practices and standards for postmarket assessment, most likely under the direction
of a scientific advisory board. New models for data aggregation are needed to permit FDA to trace back to individual cases
when necessary, and improved statistical methods will help sort out causality and distinguish meaningful signals in large
Many of these issues will be explored by an active surveillance pilot program sponsored by the Pharmaceutical Research and
Manufacturers of America (PhRMA). After more than a year in development, the project is being launched as a public–private
partnership involving PhRMA, FDA, and the Foundation for NIH. Janet Woodcock, director of the Center for Drug Evaluation and
Research (CDER), will chair this test program for organizing and operating a drug safety query system using a distributed
In the future, it may be possible to monitor medical product safety through a national health information network that connects
clinicians, consumers, and providers across the healthcare system in real time. FDA would have access to such data for public
health purposes, but would have to ensure that information exchanges are secure and confidential. FDAAA specifically instructs
FDA to examine privacy issues, and for the Government Accountability Office to report on the agency's progress.
A linked system would give a broader picture of health problems and better track patients that change providers. But it would
also require a higher degree of consistency and transparency, Woodcock explained at the Brookings forum. "This could be something
for the future," she said. "We would not do this to start, but don't want to rule it out."
Effective communication about safety signals from interim results will be a challenge, as will efforts to provide adequate
and sustained financial support. These are issues that FDA and its Sentinel partners will address, as well as concerns about
scientific accuracy and data reliability, said von Eschenbach. FDA is not implementing the Sentinel System "solely because
Congress told us to, but because it's the right thing to do. FDA must and will do this," von Eschenbach said.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at firstname.lastname@example.org