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Scott Gottlieb, MD - 2005 Medical Innovation Summit

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
2005 Medical Innovation Summit
Cleveland Clinic Foundation, Cleveland, Ohio

Remarks by
Scott Gottlieb, MD

Deputy Commissioner for Medical and Scientific Affairs
Food and Drug Administration


October 25, 2005


Thank you for inviting me to speak here tonight.

I want to talk today about how we continue to make sure that patients have available to them the latest advances in technology, both big and small, when it comes to the medical products that they use.

And how we continue to provide patients and doctors with timely and up-to-date information about the risks and benefits of those products – even with so many new advances becoming available all the time

In short, I want to talk about how we continue to make sure that innovations made in engineering processes and in basic science that you are all pioneering can quickly translate into improvements in medical devices and medical care, so that people don’t have to wait many years to realize the benefits of new scientific advances.

I want to talk about how FDA can facilitate these things, and where we all need to be working together to make sure that patients are safely benefiting from the best new technologies.

Advances in medical technology are occurring at breakneck speed and spawning overwhelming benefits in peoples’ health and improvements in our approaches to medical care.

Cardiac medicine is just one of many therapeutic areas virtually transformed by innovations in medical technology.

Breakthroughs such as coronary stents, implantable defibrillators and minimally invasive bypass surgery have helped reduce the death rate from heart disease by 40 percent since 1980.

In cancer care, DNA-based tests and other advanced diagnostics are saving thousands of lives by detecting cancer earlier when it’s more treatable.

In fact, to help facilitate the integration of these tools into medical practice, and drug development, soon FDA will be announcing a broad collaboration with the Centers for Medicaid and Medicare Services and the National Institutes of Health to validate the use of PET as a tool for measuring tumor response to new drugs in some clinical trials.

Taken together, it’s clear that we’re only at the leading edge of a remarkable period of medical progress that is being enabled by innovations you all are developing.

Many things have enabled this kind of progress, but not lost on all of us should be the unique process for translating discoveries into better medical devices.

Of the many qualities that separate device development from drugs, one of the most challenging but also most valuable for patients has been the process that allows incremental innovations to quickly translate into improvements in the devices patients use.

Small improvements in manufacturing, in materials science, in engineering, and in the construction of devices are able to quickly make their way into improvements in the products themselves and, in turn, into the medical choices that patients have.

In Washington, we all talk about enabling science to quickly make it to the bedside.

Perhaps more so than any other field of science and medicine, this promise plays out every day when it comes to medical devices.

This ability to quickly move innovations to the bedside is very clearly a reflection of the hard work of the people who work inside device development companies, as well as the FDA’s device center.

But it is also a reflection of the modern rules that guides the regulation of devices and the unique qualities of device development itself.

As a general matter, the law gives our device regulation process a more refined toolkit to manage product risk and allows us to better calibrate our regulatory touch according to risk.

We classify devices by how much potential risk they pose. Taking the toolbox analogy further, instead of one regulatory wrench, we have an array of wrenches, all in different sizes, to address different risks.

For less risky devices, the 510(k) process imposes a lighter regulatory burden on developers. Although some changes to 510(k)-cleared devices require submission of the more extensive PMA, many can be dealt with by another 510(k) submission.

And CDRH has done a tremendous job developing alternatives to the traditional 510(k) so that sponsors have several options under this provision of the device statute.

Thanks to Congress, we also have a completely new route to market for medical devices that are new but not highly risky. I am referring, of course, to the “de novo” process.

FDA can look at a new device and decide, for example, that a submission based on existing published literature is adequate, making expensive and time-consuming clinical trials unnecessary. This is how CDRH recently handled a novel microarray.

There are many other ways in which medical device regulation and the corresponding laws are a lot more flexible than drug regulation.

So the law that governs our regulation of medical devices has a lot of more modern approaches that allows us to adapt our approaches to the complexity and risk of the technology itself.

This more modern approach enables FDA to create a regulatory framework that better accommodates the continual evolution of the underlying technology we’re asked to review.

But this modern approach to regulation and to the translation of science to the bedside also presents FDA and product developers with some challenges.

I want to talk about three of them.

The first challenges are regulatory challenges unique to FDA.

The constant stream of innovation that we’re asked to review is resource intensive. This challenges us inside FDA to improve our own internal processes.

This is a topic I also want to get back to in some thoughts I’d like to share about the Medical Device User Fee and Modernization Act or MDUFMA. But from a regulatory standpoint, as an agency we need to pay close attention to how our regulatory tools are deployed, to make sure that we’re using our tool box efficiently, and not imposing unnecessary costs or time delays on the development of potentially lifesaving new medical products.

With the cost of healthcare increasing, and with more and more people potentially priced out of the benefits of new medical innovations, we need to make sure that in everything we do, we’re taking steps to make sure that our approaches are efficient and cost effective.

The modern approach that we’re able to take to device regulation and to the rapid translation of science to the bedside also present a number of challenges that FDA and medical device developers share -- and I’ll focus on two in particular

One is that we must do more than ever to monitor the performance of their products after they are approved, and make sure that we are quickly discovering and sharing information about problems that do arise.

Improvements in material and manufacturing and engineering make today’s medical devices smaller, hardier, and more sophisticated.

This is important progress that has benefited literally millions of patients who can now have unobtrusive and more functional cardiac defibrillators implanted in their chests or stronger prosthesis in their hips.

But this technical sophistication sometimes also means that there is more opportunity for small errors to have bigger consequences.

This is the essential paradox. What used to be a minor engineering problem years ago, that might not have been made manifest in the overall performance of the devices or affected their safety, can become magnified and have more potential for causing health consequences as the devices themselves get smaller and more sophisticated.

So as the opportunities for significant public health benefits from new medical devices continues to dramatically expand, the margin for error in their manufacturing sometimes continues to shrink.

This means we need to be looking harder, after devices and engineering changes are approved, for new potential problems with their performance.

Finally, the third challenge -- and another one that I believe FDA shares with you -- deals with how we all interact with patients and especially the broader medical community.

As scientific advances in medical devices become more rapid and commonplace, and are more rapidly translated to the bedside, FDA and device developers are challenged to make sure that we’re taking new steps to clearly and effectively communicate information about their performance.

We need to work harder and more creatively to provide the information and tools that people need to adequately weigh the pros and cons of these kinds of innovations as they make personal choices about their health.

I want to come back and provide just a few more thoughts on each of these three challenges, and to tell you what we’re doing at FDA to address each of them, and I want to tell you where we are going to need your help.

First, with respect to the challenges posed to FDA and to our regulatory process.

Under the leadership of Dan Schultz, the head of our device center, and his dedicated team, we have taken new steps in recent years to make our processes for evaluating medical devices in the premarket period more efficient and more predictable to help improve the opportunities to bring beneficial new technologies to patients.

And we have worked to better identify the places where things can go wrong with new device development so that we’re focusing our resources on places that pose the most potential risk.

For example, we’ve issued a number of guidances in the past several years to improve the clarity and predictability of our review process.

We’re taking new steps to calibrate our inspections to the level of potential risk, by developing risk assessment criteria.

This criterion takes into consideration probability and the potential severity for harm, as well as focusing our field inspection resources on medical devices and on manufacturers that have the greatest likelihood of encountering problems that could pose public health harm.

We’re also taking new steps to adapt quality systems to assure the predictability of our review process. And we’re making use of retrospective peer assessments and using quality assessment teams to provide a comprehensive supervision of our process.

We’re going to be initially focusing these efforts on some of the most challenging cross-cutting areas like biocompatibility.

In all of these efforts the opportunities and resources that have been made available to the agency under the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 have been an important catalyst in enabling us to adopt new tools and implement fundamentally better ways for developing the science that guides all of our device review process.

Part of our commitment under MDUFMA was to meet certain performance goals that reflected, in part, the process improvements that we were able to make as a result of these additional resources.

People inside our Center for Devices and Radiological Health have been working extremely hard on these goals, and I’m pleased to say they are meeting all of them.

But there is also concern inside FDA that not all of the goals have been as closely aligned as others with the bottom line that we all share: making the process for evaluating products as predictable and scientifically rigorous and efficient as possible.

And there is some concern that at least some of these goals may have kept reviewers from having as much interaction as they would like with companies by focusing attention on formal communications rather than collaborative exchanges. Or worse, kept them from devoting as much time as we’d like to on the development of things such as guidances

There are clearly many cases where having good guidances for product areas can lead to improvements in the applications we receive or in our interactions with scientists and product developers.

These things can help accelerate the achievement of performance goals that measure the efficiency of the review process.

It’s our obligation to find these opportunities and to make sure we’re also investing time and resources in developing the processes and guidances that will lead to these long term and fundamental improvements in our review process even as we focus on meeting short term review goals.

And so while we are grateful for the resources that MDUFMA has provided and the improvements it has enabled, we have also learned much since the program was first implemented. Under a potential MDUFMA two, we may have the opportunity to more closely align our review goals with measures that even more closely reflect the bottom-line objectives that we share – for an efficient, rigorous and predictable process.

I hope many of you will join us for the workshop we’re having in November, our Third Annual Stakeholder Meeting on MDUFMA.

And this leads me to the other two challenges, the ones where I think we have some shared obligations, and where we need your help.

The first is that today we must do more than ever to monitor the performance of medical products after they are approved, and make sure that we are quickly discovering any potential problems that might arise.

To do this, at FDA we are using a lifecycle approach to how we look at medical devices, and focusing more attention on the kinds of systems and processes we have in place to monitor products after they are approved.

Now I have spoken to people in our device center about our efforts to improve our post-market processes, and there is consensus that our pre-market review efforts and our post-market resources are inextricably linked.

The more that we can develop confidence that our post-market tools will be able to quickly and accurately discover problems that arise, and before patients are harmed, the more confident we can be in our pre-market approval process and fulfill our desire to efficiently move promising new technologies to the bedside.

As the complexity of new technologies continues to increase, along with their lifesaving benefits, it becomes more challenging to reveal all of the subtle things that can go wrong in any reasonably sized clinical study.

As I mentioned, as these devices get more sophisticated, and their lifesaving benefits more numerous, the margin for engineering errors also shrinks, and the ability for things to go awry sometimes increases.

So the only way we are going to be able to maintain the efficiency our review process over these innovations is by building more rigorous tools for monitoring them after they are cleared or approved.

And so at FDA we are taking new steps to improve our post-market system when it comes to medical devices.

Under our MedSun and LabSun initiatives, where we actively gather data about side effects from hospitals and other healthcare establishments, we are developing new tools and methods to improve the number and type of reports we receive.

We are moving toward obtaining “real time” data from these networks, and are increasing the number of laboratory reports we get from participating hospitals and targeting new kinds of reports such as pathology and in vitro diagnostic tests.

We are also working to improve access to additional information and new electronic reporting tools and will be implementing changes to our own internal processes for reviewing these data and analyzing them for signals and for safety problems.

For example, we’ve developed an internal tracking system for new devices and for the information we get from the different kinds of reports we receive about manufacturing changes and other measures of post-market performance.

And we are working on new guidance to improve the format of the information that we ask sponsors to submit for certain kinds of devices, so that it is easier to integrate this information into our post-market review processes.

We are mindful that we depend on product developers to collect this information and to help analyze it and to make sure that it continues to be submitted to us in a timely and complete way. We appreciate all of the collaborative work we do with you every day.

It’s often hard to uncover the patterns that might suggest that a new innovation or manufacturing improvement has led to some new and unwanted side effect or safety problem and sometimes a device developer is in a good position to uncover these kinds of links.

So we need your help in working on these challenges.

The third and final challenge that we at FDA share with all of you is in how we communicate with the broader medical community.

Communicating medical information, and especially risk communication, is a difficult but increasingly important challenge, especially as devices evolve more rapidly and innovations hopefully become available over shorter time frames.

We need to make sure we are helping doctors incorporate these new benefits into their medical decisions, and that they understand where they need to be looking harder for new potential problems that might also arise as a result of innovations or engineering changes.

We’re taking new steps to work more regularly and collaboratively with health professional societies, to improve the information we receive as part of our post-market monitoring process but also to make sure that we’re communicating effectively with health professionals and with patients.

For example, we recently held a day-long conference in collaboration with the Heart Rhythm Society to look specifically at communication challenges around implantable defibrillators and pacemakers.

This format worked extremely well, and could be used in other product areas.

As a result of the HRS Policy Conference, an ICD Working Group was created both at FDA and HRS.

Among the work that FDA’s ICD Working Group might be doing in collaboration with the Heart Rhythm Society ICD Working Group is using CDRH’s current Medical Device Fellowship Program to leverage outside medical professional resources, and the creation of a joint website where patients and doctors can find product information.

We also plan to develop specific MDR reporting for ICD and pacemakers which includes interrogation data, and the development of ways to improve our risk/benefit communication, such as new kinds of Dear Dr. and patient letters, recalls, public health notifications that are developed collaboratively with experts among the ranks of outside health professionals.

We are also exploring the creation of a process where we have members of a health professional advisory panel review post approval data and provide recommendations to FDA.

This area again is another place where we need your help.

Through your interactions with physicians and the educational material you make available, product developers often have meaningful and frequent contact with health professionals.

These encounters need to continue to include more opportunities for teaching health professionals about the potential problems with new devices that could come along with all of the improvements, as well as opportunities to solicit information about performance of devices so that it can be made available to the FDA.

The bottom line is this: as technology improves, and as device developers and FDA work to continue to make new innovations and even incremental improvements available to patients more quickly, we also have certain new responsibilities that come with the sheer speed of technological change and the complexity of the innovations themselves.

All of this improvement has resulted in obvious and measurable gains in health for patients, but all of this improvement doesn’t come without its own burdens and obligations.

And so we need to work together to continue to make sure that the benefits of innovation and the rapid deployment of improvements in medical products continue to outweigh any new risks that these better products can sometimes pose.

We share a vision for American health, one in which American patients are well informed about health issues, where they lead healthy lifestyles, where they have good knowledge to help prevent diseases and the ir complications.

An d whenever they need it, they ge t access to the best, highest quality healthcare around, the most innovative health care system in the world.

I want to say that I’m looking forward to working with you on these very important issues. Thank you all very much.