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Scott Gottlieb, MD - Speech before Part 15 Hearing 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
Part 15 Hearing on Risk Communication

Remarks by
Scott Gottlieb, MD

Deputy Commissioner for Medical and Scientific Affairs
Food and Drug Administration


December 8, 2005

I want to thank you all for coming today and extend a warm welcome to our panel. At FDA we depend on scientific gatherings like these to get important input to guide our work. And no topic is more important than how we communicate with the public.

And no subject can perhaps benefit more from frank, open dialogue with the public than this one.

I also want to acknowledge the dedicated staff of FDA’s Center for Drugs, especially Paul Seligman and Lee Lemley, in planning today’s meeting.

On behalf of Acting Commissioner Andrew von Eschenbach and the FDA’s Commissioner’s Office, I want to welcome you all here today.

Across FDA, there is widespread agreement that we want to work especially hard, and look for new and effective ways to improve the way we communicate information with the public.

Whether it’s improving our dialogue and our collaboration with physician groups, or more carefully crafting the messages we deliver to consumers, or improving the predictability and consistency of our relationships with the press, we are working hard to improve and expand the tools and practices through which we communicate information.

Let me take a step back first, and give you my one sentence description of FDA -- my elevator speech.

Our work at the agency is complex, and requires expertise and dedication that is hard to measure. But if I was asked to boil it all down into a simple phrase, I’d simply say that a lot of what we do at FDA involves helping patients manage the risks and benefits of their healthcare decisions.

Our job then, when you boil it down, is to help turn raw information about medical products into practical knowledge that patients and doctors can use to make personal decisions about their health and healthcare treatments.

At FDA, we receive a lot of data about new medical products, and medical products already on the marketplace, whether it’s a new application for a drug, or the adverse events we receive through MedWatch.

With the help of our tools, with the energies of our skilled professional staff, and with the aid of the guidance we get from outside experts, we turn this raw data into useful knowledge that doctors and patients can use to help guide their decisions about how to most effectively use medical products to improve health.

That knowledge is what you read on our labels. It is what you see in our healthcare advisories. And it is what we want to discuss with you hear today, how we can do a better job of translating the most useful information for informing medical practice.

In short, how we can do a better job of getting this information to you when you need it and in a way that it can be more easily and more effectively integrated into the choices that patients and doctors make.

But our ability to generate and share this knowledge is only as good as the information we receive -- and only as useful as our ability to communicate it efficiently and effectively to the people who need it. And that is why we need the help of consumers and healthcare professionals. That is why we need your help here today.

It is clear to all of us, that the social sciences of disseminating risk information, and of measuring how consumers respond to and use this information, are sciences that are being rapidly developed and expanded.

If you look inside many corporations today, you’ll find people expert in risk communications whose primary job it is to craft information tools that can be more effectively used by consumers. This wasn’t always the case. Such experts didn’t always exist.

A large amount of research findings has accumulated since the 1970’s, when risk issues started to become central themes in the society.

Risk communication studies first emerged in part, from risk perception research that was aimed at using perceptions of risk to provide more effective information.

Gradually, the field recognized that risk perception differences were more fundamental than just explaining risk estimates in a simpler way.

Gradually, a segment of the field moved toward adopting approaches to “risk communication” -- where dialogue, not one-way-information campaigns, emerged as a significant theoretical basis, as well as a method in research and safety implementation work.

At FDA, the task of measuring consumer perception and peoples’ reaction to information, and using this scientific information to more finely tune the way we speak, is becoming a more important part of our work.

As the amount and complexity of information that we provides continues to mount -- a result not only of our desire to speak more openly but also the increasingly complexity of medicine and science itself -- we know that we also need to continue to improve how we approach the social sciences of risk communication and the social sciences of measuring consumer perceptions to information.

This is true not only in how we communicate safety information about drugs, but in many parts of our work.

It is true, for example, in how we measure consumer response to drug advertising to ensure that there is fair balance.

It is true in how we craft a public health advisory warning of a problem with a medical device.

And it is true in how we measure how people respond to the health information included on food labels – so that we can provide appropriate guidance that makes sure we take opportunities to promote information that motivates people to adopt healthy diets – diets that can improve their lives and even help to prevent the onset of certain disease.

At FDA we are dedicating new resources and efforts to improving our scientific approaches to the regulatory work we do -- to improving our hard science. Our critical path initiative, for example, is a big step forward in taking new approaches to improving the science of drug development.

We are equally committed to improving the social sciences that guide our work. They are just as important. The best regulatory science in the world can’t have its full benefit if we are not effectively communicating what we learn.

And so today continues an important discussion on how we can improve the science of risk communication. And more than perhaps any other scientific work we engage in at FDA, making improvements here truly depends on public input.

Public perceptions of risk information are inextricably linked to our ability to improve the way we speak, and in the way we craft our information tools.

And so we are grateful for the opportunity to engage in this dialogue today, and we are committed to expanding on our opportunities to improve the social sciences that govern the way we inform the public of what we learn when it comes to safe and effective ways to benefit from medical products.

Thank you for coming today to join us in this dialogue, and on behalf of the entire agency, I want to welcome you to this meeting today.