FDA Seeks More Timely Drug Information Electronically - The new Sentinel system aims to expand access to data on medical product safety and patient effects. - BioPharm International


FDA Seeks More Timely Drug Information Electronically
The new Sentinel system aims to expand access to data on medical product safety and patient effects.

BioPharm International
Volume 23, Issue 3


OMOP's agenda reflects strong industry interest in shaping and supporting Sentinel policies and operations. Unfortunately, this coalition is the main way for manufacturers to influence the project at this time because there are no industry representatives on the Sentinel planning board and OMOP is not an official participant in the program, largely because some stakeholders believe that manufacturer involvement could taint the validity of results. A main concern of the industry is that companies will be denied access to Sentinel data for their own analysis or for postmarketing studies. Woodcock noted that the mini-Sentinel system cannot yet support third-party postmarketing analyses, and that the FDA will have to deal with industry access after the full "industrial-strength" Sentinel emerges.

Ensuring the privacy and security of patient health records is another key issue shaping the Sentinel program. The main advantage of the distributed data model is that the FDA avoids building its own mega-database and instead leaves individual patient health information with the insurance company or health system that holds the records. That data source evaluates the information, transmits summaries to Sentinel, and confirms a specific diagnosis or report if needed. It remains to be seen how well the FDA can assess safety signals through this arrangement; even direct access to de-identified data may not be sufficient to confirm that a safety issue is real.

Another tricky issue for industry and policy makers is the timing of public disclosure of safety information. Releasing information too early increases the possibility that a report may be wrong or incomplete and thus raise unnecessary alarm. But delaying communication on an emerging safety problem may result in patient harm and expose program participants to "failure to warn" liability charges. Moreover, the FDA has to determine how it will use Sentinel findings in regulatory decisions. Confirmation of safety signals could result in changes in a product's labeling, agency alerts to healthcare professionals, and public warnings about appropriate drug use. Despite concerns about the completeness, objectivity, and timing of drug safety reports, "what we're going to get is going to be better that what we have right now," Woodcock predicted.


Although Sentinel's prime purpose is to serve the FDA's regulatory mission, the long-term vision is that the program will become part of a larger health information system that also provides data for outcomes studies, comparative effectiveness research (CER), and health system quality reporting. Manufacturers support the goal of building such a multipurpose network, said Paul Stang of Johnson & Johnson at the workshop, but this requires more investment in research methods, in standards for data sources and evidence, and in governance of emerging models.

Carolyn Clancy, director of the Agency for Healthcare Research and Quality (AHRQ), concluded the program by describing AHRQ initiatives to build distributed data research networks and to improve patient registries that can answer queries related to the effectiveness and safety of medical services and products. An over-arching goal is to identify synergies between postmarketing surveillance and CER and to provide incentives for healthcare providers to participate in e-health activities.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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