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  1. Speeches by FDA Officials


Event Title
Remarks at the Tenth Annual Sentinel Initiative Public Workshop
February 7, 2018

Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Tenth Annual Sentinel Initiative Public Workshop
Bethesda, MD

It’s a pleasure to be with you today, to reflect on the past and speak about the future of one of the most important initiatives – and collaborations – ever to be undertaken by the FDA.

On a personal level, it is especially meaningful to join you for this 10th anniversary Workshop, because Sentinel played such a significant role during my initial tenure at FDA. Although Mark and I weren’t at the agency when Sentinel came into full fruition, we were involved in its early years, in the work leading up to its launch.

So, it is especially gratifying to see how the promise of this project has been realized and today plays an important role in FDA’s safety work.

With that in mind, I wanted to offer just a few opening thoughts about how Sentinel has developed into such a successful data infrastructure that today provides a truly 21st Century Safety Surveillance System -- and how we might build on this achievement.

Sentinel is a powerful tool for FDA. It creates scientific capacity for us to recognize and address safety issues in a timely fashion. It gives FDA broad and deep access to electronic healthcare data that extends all the way back to the medical record and the patient encounter. And, by standing this up in a cost-effective and scalable system, it has allowed FDA to enhance public health safety in previously unachievable ways.

Sentinel has enabled us to develop innovative ways to monitor FDA-regulated products, answer numerous questions simultaneously, and do it in a matter of weeks and months, rather than years.

The idea for Sentinel was based on a very simple principle – one that goes to the heart of FDA’s science-based mission. 

We realized that to keep up with the accelerating pace of scientific discovery, we needed to develop high-level tools that would allow us to apply and translate the data from the use of those products into real-world information that would benefit patients and consumers.

We recognized the limitations resulting from the passive way we gathered a lot of our data on safety. Sentinel was a chance to be much more active in how we collected safety information -- by tapping into real world observational data that could be queried to answer scientific questions.

Sentinel also has been a critical piece of our comprehensive response to patients and caregivers, who want and deserve more and timelier information about the benefits and potential risks of products they use.

Sentinel was one of several successful initiatives that FDA developed to drive innovation and incorporate emerging technologies into everything we do to protect and promote the public health. 

By linking projects like Sentinel and the National Evaluation System for Health Technology (or NEST) with other data-based initiatives at our sister agencies and at organizations outside of the government, we’ve built a rigorous and robust foundation for producing more useful knowledge at a fraction of the cost required by previous efforts.

Today, Sentinel has become one of the largest and most successful uses of “big data” in healthcare -- a more efficient system that can generate much more high-quality evidence in a shorter time.

And though it continues to develop, we already have realized many of the benefits that come from the ability to use real-world observational data as a tool to monitor medical product safety and identify and further evaluate concerns.  Those benefits can be extended in the future.

For example, we should consider how Sentinel might be used to answer questions about efficacy; and how FDA might have tools and resources to take on these questions in certain narrow circumstances where a question around a product’s efficacy also relates to its safety.

One such situation involves the long-term efficacy of opioid drugs and the long-term prescribing of these drugs.

For example, if the chronic use of opioid drugs is marked by diminishing efficacy from these medicines, then long-term prescribing might lead to higher and higher doses being prescribed over time. That situation could, in turn, lead to more dependency and in some cases addiction.

This clinical question is something that we ought to fully understand. Right now, however, we don’t have good data on the long-term efficacy of opioids, even though they’re prescribed for these purposes.

By leveraging large databases containing electronic health records, disease-specific registries, and claims data, we’ve made significant advances in our understanding of health and disease, safety issues, and the relationships between health-related factors and outcomes. 

You’ll hear plenty of statistics on Sentinel today; but let me offer a few of the impressive numbers that frame Sentinel’s success.

There were 223 million members in 2000-2016 and 178 million members with information from both medical and pharmacy benefits.

There are 43 million people currently accruing new data

There are 425 million person-years of observation time

There are 7.2 billion unique medical encounters

And FDA has done 254 analyses using the Sentinel Common Data Model and reusable modular programs since the full activation of the Sentinel System in 2016, including 116 in 2016, and 138 in 2017.

None of this would have been possible without the enormous contributions of our data partners who helped us build Sentinel.

Their sharing of data and scientific expertise allowed FDA to fulfill its important public health mission. By joining together, they enabled the creation of this invaluable resource for public health. And their continued collaboration has allowed us to expand and improve the capabilities of Sentinel and transform it into a true national resource.

The Sentinel System is a model for how FDA can work with diverse elements of the health care industry, researchers, and patient groups to accelerate the pace and impact of post-market safety activities. 

This type of RWE infrastructure is proving useful for other activities- safety studies by other organizations (IMEDS), and studies of effectiveness (the flu vax study, for example) that could lead to both new knowledge and changes in effectiveness-related labeling.

We’re committed to continuing this model collaboration. And we need to advance this infrastructure.

Sentinel has become critical to producing the high-quality evidence needed to guide FDA’s decision about products it’s charged with regulating, and help us better inform patients.

But we know that to meet our growing evidentiary and scientific needs through access to these data sources, this tool must continue to evolve. One of the key questions you’ll be addressing today is just how does the FDA and its collaborators build on the successes of Sentinel? 

The increasing innovation of IT systems, cloud-based technologies, blockchain, and AI and other types of advanced computing, offers continuing opportunities to advance Sentinel System’s development and improve its data and analytic capabilities. Advances for post-market safety surveillance as well as a growing range of research needs.

Our PDUFA VI commitments for Sentinel charge us with increasing the sophistication of our core capabilities, especially in areas of pregnancy safety, signal detection, analytic tools, and filling gaps in data sources to improve the sufficiency of the System to address safety questions. 

We’re also committed to improving the system’s transparency and how we communicate with industry and the public.   The Sentinel System is leading the way to “faster, better, cheaper” analyses, proving how Real World Data (RWD) is valuable for the whole healthcare enterprise.

This workshop provides an opportunity to discuss the possibilities and solicit ideas from across the stakeholder community on how to achieve such aims over the next 10 years. 

And I know that several of my colleagues will be addressing these points in more detail during the sessions.

I hope your discussion on this topic is productive. 

We can benefit from your help.

I want to again thank all the partners for their commitment to this effort. Each of you is key to its success. And each of you plays a vital role in finding new solutions to protecting and promoting the public health.

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