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Scott Gottlieb, MD - Workshop on Risk Communication

This text contains Dr. Gottlieb's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
FDA Center for Devices and Radiological Health
Workshop on Risk Communication
North Bethesda, Md.

Opening Remarks by
Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs

September 26, 2006

Thank you for the opportunity to provide some introductory remarks here today. The work we do at FDA is fundamentally about managing information. The agency receives reams of raw scientific and medical data in its applications, in its adverse event reports, and in its manufacturing supplements. Our experts cull these data to piece together medical conclusions that can become the basis for good decision making by patients and healthcare providers.

Our medical and scientific staff is world class in analyzing this information, and separating signals from certainties when it comes to understanding the risks and benefits that medical products pose and providing recommendations on their most appropriate use. It is for this work that we are regarded as the gold standard around the world.

But when it comes to providing the information needed to help consumers make every day choices and decisions about the healthcare products that they use, our analysis is only as valuable as our ability to effectively communicate it. And for too long, we did not pay as much attention to how we approached as a discipline communication, and especially communication about risk information. We spent a lot of time taking steps to improve the hard sciences, but not as much time taking steps to improve the social sciences.

That is changing. And today's conference is a big part of the practical steps we have taken in recent months to improve our approach to risk communication and to how we approach social sciences as an agency. Just as our Critical Path effort is aimed at improving the scientific tools that we use in the evaluation of new medical products, there is an analogous effort afoot inside FDA to improve the tools we use in approaching social science.

As part of our PDUFA discussions, for example, we have talked about how we can create a framework for enabling new, scientifically-validated tools such as unbiased survey instruments for measuring fair balance in consumer advertising or for measuring confusion between similar sounding drug names.

On the device side of our house, we have had to re-think how we label our communications, how we refer to recalls for example, as the complexity of the products that we regulate increases and the nature of the incremental innovation inherent in medical devices becomes an even more iterative process.

When is a recall that is triggered by a software fix, for example, more appropriately labeled by language that may more easily recognize the change as part of a constant process of product improvement? What is the best way to communicate this information to patients and providers so they can most effectively incorporate this fundamental nature of device complexity into their decisions to use a medical product? Another question that has come up is how FDA and particularly CDRH can leverage relationships with groups like the Heart Rhythm Society to more effectively craft joint messages that contain an element of medical advice, drawn from practitioners, when the agency takes an action on an important medical product. These are just some of the questions that I know will be discussed here today.

Across FDA we have devoted new resources to risk communication and put in place new approaches; for example, making our senior scientific and medical staff far more accessible when we go out with important safety-related announcements -- often through regular media conference calls, we have undertaken more direct outreach to physician groups through an effort led by our Office of Special Health Issues, and we have sought to provide more regular public health advisories around important safety-related issues. We have also engaged in more gatherings like this one; so we can discuss together new ways that we can continue to improve our approach to risk communication.

All of these efforts are challenged by the growing complexity of our work, and of our communications needs. More and more, we are called upon to discuss matters that are not settled science but areas of concern that we are actively investigating. This kind of transparency is essential for patients and providers, so they can have full information about the medical products they use. But it also challenges us to find ways to communicate that carefully calibrates the language and the tools we use to speak to the level of risk that we perceive a particular product or piece of information poses. Over warning about risk can be as dangerous as under warning, by discouraging the safe use of medical products that we know have proven benefits. The exercise of speaking about these interim risks, and unsettled science, requires the agency to constantly strike to achieve clarity, candor and humility in all of its communications.

In the end, the value of our scientific work is commensurate with our ability to effectively communicate it. New information mediums such as the Internet give us new opportunities to speak to the public, but also add new complexities to our work, making our ability to communicate information in a timely, transparent way more important.

I am delighted to join you here today so that we can work together, creatively, on ways we can continue to improve how we communicate risk information, and how we help consumers make more informed, more personalized, and more optimal choices about the medical products they use.