Enhancing drug safety
One important FDA IT initiative is to provide more timely information on the safety of all regulated products. To this end,
the agency is centralizing adverse-event analysis through its Adverse Event Reporting Systems (AERS) and is creating a MedWatch
Plus single portal for public reporting of adverse events. Work continues on a final rule requiring electronic filing of adverse-event
reports for drugs, vaccines, and medical products. Small drug and biotechnology manufacturers fear the mandate may be costly
and difficult to implement.
Probably the most high-profile project involves establishing a proactive electronic information system that can detect signals
of adverse events for medical products. The aim, as specified in the FDA Amendments Act of 2007 (FDAAA), is to augment AERS
with a more active program able to monitor health records on 100 million people by July 2012.
FDA aims to meet this goal through a series of steps over several years. The agency launched the Sentinel Initiative in 2008
and now is establishing a "mini-Sentinel" system that will tap into medical records held by large healthcare plans and insurers.
FDA will pose queries about medical products to databases established by CIGNA, Kaiser Permanente, and the health maintenance
organization Research Network, among others. A second phase next year will expand the program by accessing data from Medicare
and other government healthcare programs. The queries may be triggered by evidence of possible risks seen in clinical trials
or by adverse-event reports on marketed drugs. FDA can ask Sentinel partners to monitor for certain events and to assess evidence
of health conditions associated with drug use as part of its effort to see if quickly gathering more information strengthens
initial safety signals.
The agency recently signed a $72-million contract with the Harvard Pilgrim Healthcare system to coordinate operations for
a distributed data model that can obtain near real-time signals and ensure data quality from appropriate sources. The program
already can access information on 60 million patients, according to Richard Platt of Harvard Pilgrim and Harvard Medical School,
who heads the project. That's well above the 25 million patients that FDAAA instructs FDA to monitor by July 1, 2010. Mini-Sentinel
also will work with researchers and technical experts at academic centers, private firms, and nonprofit 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 Healthcare Reform
at the Brookings Institution. FDA Commissioner Margaret Hamburg opened the conference by noting the growing importance of
postmarketing surveillance of regulated products. She cited key questions that need to be addressed to have a fully functioning
Sentinel System such as how to design a common data model that can compare and analyze data sets, and the need for consensus
on methodologies for proving and disproving causal relationships between a product and an outcome.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), described Sentinel as one element in a broader
agency effort to encourage safe use of medications, to revamp FDA's pharmacovigilance system, and to explore the use of social
media to publicize safety issues. FDA also is participating in numerous worldwide collaborations that aim to better understand
drug effects in different populations.
Judy Racoosin, the FDA scientific lead on Sentinel, emphasized that the initial system will help the agency understand the
intricacies of gathering safety signals on drugs from multiple sources and closer to real time. 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.
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 FDA, the Foundation for the
National Institutes of Health, and the Pharmaceutical Research and Manufacturers of America (PhRMA). Through this partnership,
manufacturers are working to define viable approaches for assessing drug safety and for communicating those findings to health
professionals and patients. At the Sentinel workshop, Patrick Ryan, manager of drug-development sciences at GlaxoSmithKline
(London), noted that OMOP is assessing the diversity in analysis methods and making all of its research available to the public.
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