This expansion of AERS, however, is not designed to build a giant FDA health-information database for medical-product monitoring.
Instead, the agency will expand postmarket surveillance by accessing data on drug use, patient outcomes, and specific safety
issues held by private health plans, insurance companies, database operators, government agencies, and medical-products manufacturers.
The aim is to negotiate contracts and partnerships with these existing electronic databases to establish a national, integrated,
electronic distributed network for monitoring medical-product safety. By using a distributed network, all the personal medical
data remains behind firewalls, thus reducing concerns that FDA is compromising patient privacy and data security.
FDA has been laying the foundation for the Sentinel System for years through arrangements with healthcare "data owners" that
permit it to pose safety-specific questions for evaluation through electronic health records, claims databases, and other
information sources. For example, the agency has contracted for several years with UnitedHealth Group's Ingenix, Vanderbilt
University, Kaiser Foundation Research Institute, and Harvard Pilgrim Health Care to access pharmacoepidemiologic information
that can test hypotheses arising from AE reports. FDA's Center for Biologics Evaluation and Research (CBER) works with CDC,
the Veterans Health Administration (VHA), the Centers for Medicare and Medicaid Services (CMS), and large health plans to
monitor influenza-vaccine use and related outcomes. FDA also supports the Severe Adverse Events consortium to gain more understanding
of the genetic basis of drug-induced serious AEs. Several projects with the Agency for Healthcare Research and Quality aim
to assess the use of distributed networks for comparative effectiveness and safety studies.
A new CMS policy now gives FDA access to one billion pharmacy claims per year, collected by the Medicare Part D drug-benefit
program, a treasure trove of healthcare-use data (see sidebar "Evaluating Part D"). With additional funds to support postmarket
safety surveillance, FDA plans to expand its access to CMS, VHA, and health-plan databases to further expand its ability to
detect and assess AEs related to marketed drugs.
Evaluating Part D
Shaping the system
FDA and its partners are beginning to map plans for operating the distributed network, but the details are still "a matter
of discussion," said Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology, at the DIA annual meeting.
FDA, health plans, and database operators expect to establish a charter that defines which entities may join the partnership,
what data sources will be used, what queries can be run on the system, who will be able to run queries, how specific evaluations
will be paid for, and how privacy will be protected. The idea is for a nonprofit network "convener" such as the Reagan–Udall
Foundation or an academic research entity to channel information and queries to the partnership and determine how results
will be communicated to network participants and to the general public.
The partnership also will support research into best practices and analytical methods and will establish standards for postmarket
assessment, most likely under the direction of a scientific advisory board. Improved statistical methods are needed to establish
causality and to distinguish meaningful signals when working with large databases. New models for data aggregation that protect
patient privacy will be important for enabling FDA to trace back to individual cases when necessary.
Many of these issues will be examined by an active-surveillance pilot project 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, with Woodcock as chair. The aim is to test approaches for organizing
and operating a drug-safety query system using a distributed information network. The pilot will be transparent, and all parties—industry,
academia, and FDA—will have access to its findings.