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Speech before

Joint Meeting of the FDA and the Heart Rhythm Society, Washington, DC

Remarks by

Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs

September 16, 2005

Thank you for having me here this morning to give a few brief opening remarks. I want to thank Dan Schultz and his team at FDA for their hard working in bringing this event together, and I especially want to thank Mark Carlson, Anne Curtis, James Youngblood, and the other members of the Heart Rhythm Society and the other stakeholders who have come here today to work with us on taking new steps to improve how patients and doctors can most safely and effectively use lifesaving technology.

There is recognition across the FDA, led by Commissioner Crawford -- that we want to take new and additional steps to work especially hard to leverage our relationships with clinicians. To learn from practicing doctors. And to find fundamentally better ways in which we can all work together -- as participants in the medical practice environment -- to improve the knowledge and the information that people have to make the best choices about the safe and effective uses of new technologies. This is especially true when it comes to sophisticated devices like heart pacemakers and defibrillators.

Over the next months, you'll be hearing more from FDA on precisely this goal -- how can we take new steps to collaborate more with healthcare professionals and to work with medical professional groups.

A lot of what we do at FDA involves helping patients manage risks and benefits. Our job, when you boil it down, is to help turn raw information into practical knowledge that patients and doctors can use to make personal decisions about their health and healthcare products.

Let me tell you a little more about that work at FDA, as I see it. We receive a lot of data about new medical products, and medical products already on the marketplace. With the help of our tools, with the energies of our skilled professional staff, and the aid of the guidance we get from experts such as those of you here today, 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 generating the most useful information for informing medical practice, and how we can do a better job of getting this information to you when you need it.

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 translate it efficiently and effectively with the people who need it. And that is why we need the help of healthcare professionals. That is why we need your help here today.

We need your help in sending this raw information to us, often in the form of reports on what went right and what went wrong with some of the products your patients use. We need your help in weaving this information into useful facts. We especially need your help in telling us how we should be communicating all of these findings with other providers, in a way that informs the medical decisions that you and your patients make.

Dr. Crawford and I and the entire FDA are grateful for superb work of Dan Schultz and his team in leading this effort to leverage our collaborations with healthcare providers with this meeting here today. And we are also grateful for the leadership of the Heart Rhythm Society for their work in helping this agency achieve its mission to protect and promote the public health.

In many ways, it is fitting that this society, and this medical specialty, should help us in leading this effort at FDA to work more collaboratively with medical professional groups, and to better leverage these relationships. The field of electrophysiology is close knit, with doctors and nurses and product developers working in collaboration. Any primary care provider who has ever seen a patient in a hospital with a pace maker or ICD that is thought to be malfunctioning will know what I mean. The cardiac doc is quickly on the scene, or separated only by an EKG and a fax machine. And the company "rep" seems to show up almost immediately, magnet in hand, to interrogate the device.

We're going to need this close collaboration as we move forward with some of the good ideas that Dan and his team at CDRH are looking for your guidance on today. We're going to need this close collaboration as these devices continue to grow more sophisticated, and their lifesaving benefits more marvelous.

If steel was the raw material for the 20th century surgery, silicon is for the 21st century. And the medical device industry -- led in recent years by advances in miniaturization, microchips, and materials science -- has delivered a cascade of health benefits that is unequalled in history.

Continuing to improve these medical opportunities means accomplishing the near impossible -- again and again. The good news is that innovators are continuing to make these achievements. Device designers continue to make heart devices smaller and smaller, which means reducing process geometries -- scaling or shrinking the nominal feature size of the devices populating and powering silicon chips, and continuing to fit more features into smaller spaces.

As a result, few areas of medicine have come so far in so short a period of time as the field of electrophysiology. Few areas of medicine have benefited as directly from the advances in microchips and micro-technology.

Today's ICDs for example, are up to 99 percent effective or more in stopping life-threatening heart rhythm problems. They prevent sudden cardiac death and reduce overall mortality twenty to sixty percent when compared to drug treatment alone. Advances in technology have not only allowed doctors to save more lives, it has also saved money. Implanted defibrillators cost less than half what they did fifteen years ago. They also provide savings through shorter hospital stays, fewer complications, quicker recovery, and longer patient lives.

But delivering on the full promise of these technologies is by no means a sure thing. With these unprecedented technological achievements have come other concerns, especially concerns about how to keep patients fully and quickly informed about risks. How to help patients balance these better opportunities with sometimes new uncertainties.

As the data that we're going to be discussing here today makes clear, with this growing mastery and sophistication also may come other new challenges. In particular, thanks to the hard work of Dr. Maisel and his collaborators, when we looked across the annual reports we receive about these products, we have found some increasing trends for certain kinds of problems with some devices over time, even as these devices got smaller, more sophisticated, and more robust in their lifesaving benefits.

While nobody is sure what these trends fully mean, we are sure that just as advances in technology challenge researchers to come up with better materials, better manufacturing processes, and better ways to fit more transistors on a chip, it also challenges healthcare providers to integrate all of these new technological options into their increasingly robust clinical practices in ways that require them to keep track of a lot more information.

It challenges industry to use this technology to make devices that are not only smarter and more beneficial but also safer.

And it challenges those of us here at FDA to make sure we're asking the right questions about these products to get good data in. It challenges us to make sure that we are taking advantage of our own advances in technology and science to turn these data into practical knowledge, and providing it to you in a way that is easy to integrate into increasingly complicated clinical practice.

So this means, especially, that we are communicating what we learn effectively with you all so that when a patient walks into your office, you have the information you need to guide them to the best possible decision for their own particular health problems.

That is why today's meeting is so important. It is why I am delighted to have the opportunity to open this event with these brief remarks, and to thank you on behalf of the Commissioner and the Agency for your participation here today, and your desire to help us learn from your work and find better ways that we can help patients take full advantage of new medical innovation.

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FDA Press Release (Sept. 16, 2005)

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