FDA’s Sentinel System, the national resource under development for medical product safety surveillance, was the topic of a workshop Jan 11 and 12. Convened by the Engelberg Center, the workshop focused on the impact of the system, which ultimately could allow access to others beyond FDA.

Key stakeholders came to explore a range of issues, including recently completed FDA contracts committed to the development of the Sentinel System and ongoing pilot projects tracking medical product safety, according to the agency. Broader discussion topics focused on maintaining patient privacy while conducting medical product safety surveillance; developing the Sentinel System as a national resource for medical product safety, and developing a multipurpose distributed system to conduct not only safety surveillance work but also for comparative effectiveness research, product quality assessment, and other types of health questions.

I spoke with one of those stakeholders about his impressions of the workshop and of the Sentinel System itself. Kevin Quinley,   CPCU, ARM, is vice president, risk management services for Berkley Life Sciences, which provides liability insurance to life science firms.

As FDA looks at stakeholders in this project, it may realize that the reach and impact are even broader than it has anticipated. Quinley’s perspective comes from the property and casualty insurance industry. He says he may have been the only stakeholder from this particular sector at the meeting. Most stakeholders representing the insurance industry came from the health insurance industry.

Quinley says the well-attended session provided a “40,000-ft overview on the issues surrounding the Sentinel System and what’s been done so far to construct a system to augment what FDA views as its passive mechanisms to detect hiccups or glitches or developing public health issues in drug or medical device outcomes with patients.” He says that in addition to FDA’s adverse event reporting system and any other sources, this will allow the agency to tap into what it calls a distributed database system of various stakeholders and constituencies. “It will allow FDA to go in and mine the data to augment its passive system to be more active in ostensibly being able to detect events and thus weigh regulatory action on situations that are developing that have public health implications.”

Patients’ privacy

Quinley provided his perspective on some of the topics that stood out.

“One theme that came through loud and clear,” he says, is FDA’s commitment to strike “the balance between protecting patients’ privacy and data mining as much meaningful data as possible.” Quinley says one idea presented was to make really informed assessments with regard to public health and safety implications, longitudinal studies might be needed in terms of how patients react over time. “Doing that and masking patient identities might be a very tall order or may work against each other. Privacy of individual patients versus the ability to draw meaningful conclusions, especially with regard to longitudinal studies over a period of time, with patient X at this point in time versus that point, presents a little bit of a challenge.”

One of the speakers at the workshop was Dan Troy, senior vice president and general counsel for GlaxoSmithKline, and former chief counsel for FDA. Quinley says Troy addressed the privacy concerns and concerns about the confidentiality of the Sentinel System. “The hot button here is that plaintiffs’ attorneys—if they could get at it somehow—might view the data as a goldmine in steering them toward hot spots or sectors for product liability litigation or even as evidence in terms of what did the device company know and when did they know it,” he says. “Those questions and the answers to them are often key in  either establishing legal liability in product liability cases, class actions, etc., or even punitive damages. You can put up a timeline in court and say, ‘ok, here’s the data they were receiving at this point in time and here, much later, is when they started taking any action in response to it.’”

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