September 28, 2011
Remarks as prepared for delivery
Thank you, Stephen for that kind introduction.
Thanks as well to Steve Ubl and everyone with AdvaMed for inviting me to join you today.
For decades, the medical device industry has been a shining example of American innovation and creativity. Your products – from coronary stents to dialysis technology to cutting edge imaging – have played a key role in adding 30 years to the life of the average American over the last century.
Our Department is committed to creating an environment where you can continue to innovate, improve lives, and create jobs.
We know that when you make an investment, its benefits often reach well beyond the original investor or entrepreneur. New medical technology can translate into better care and lower costs.
It can give people the gift of hearing, movement, comfort or a longer life to spend with their families.
This year, FDA cleared the first test to diagnose the early stages of Q fever, an emerging infectious disease among U.S. soldiers serving in Iraq and worldwide. Q fever can be incredibly painful. And early diagnosis is absolutely critical: it can mean the difference between full recovery and serious chronic illness.
The agency also approved the first-ever mammography device that provides 3D images for breast cancer screening and diagnosis, improving radiologists’ ability to spot cancerous cases and reducing the number of women who have to return for expensive and stressful second scans.
Technologies like these not only improve health, they also lay the foundation for the next round of innovation to come.
The medical device sector is also one of the few areas of the American economy that consistently run a trade surplus and where exports continue to grow. Last year, medical device exports measured $47.3 billion – a 38 percent gain over 2005 levels.
And with health care spending continuing to grow around the world, the Commerce Department projects that the growth of exports will continue at an annual rate of 5 to 10 percent.
We cannot take that for granted.
As we look to the future, the medical device industry and the federal government share a vision of innovation unleashed.
And the single most important thing the Food and Drug Administration can do to help make that vision a reality is to ensure the timely approval of safe and effective medical devices.
The FDA has two responsibilities: to protect the public health and to enable innovative products to be brought to market quickly. We are committed to doing both, and we are also committed to working with you to do both better.
In doing so, it’s in nobody’s interest to compromise safety for speed.
Ultimately, your devices’ sales will be driven not only by the continued growth in global demand for world-class innovative healthcare products. It will also be driven by the FDA’s approval or clearance of safe, effective, high-quality devices, which has become the international standard.
The FDA’s brand holds enormous value for the entire industry. In a recent report, the Milliken Institute put it this way, quote:
“The FDA’s seal of approval has long been considered the world’s gold standard for determining the safety and efficacy of new drugs and devices—a factor that has given the United States a major market advantage.”
We cannot afford to give up that advantage.
Yet we also recognize that, if the U.S. is to maintain its leadership role in this area, we must continue to streamline and modernize our processes and procedures to make device approval and clearance not just scientifically rigorous, but also clear, consistent and predictable.
Being unsafe or ineffective is a good reason for a product not to make it to market. A lack of clarity about the process is not.
And as Dr. Shuren mentioned this morning: creating a clearer regulatory pathway for devices has been a priority from the first days of this Administration.
Over the last two years, Commissioner Hamburg and senior leadership throughout the agency held town hall meetings and business roundtable discussions across the country to hear from stakeholders.
Taking this input into account, the agency then conducted a thorough reassessment of its premarket review programs.
And in January, FDA announced 25 steps it will take in 2011 to improve the predictability, consistency, and transparency of these programs. And I’m happy to report that more than half of these are complete and the others are well underway.
For example, we recognized the need for greater consistency in the scientific programs and policies across the agency’s medical device center. So we established an internal Center Science Council that will actively monitor quality and performance.
And going forward, we will create a network of experts to help the Center resolve complex scientific issues. This will ultimately lead to more timely reviews, especially as we confront new technologies.
We’ve also published a series of draft guidances for both industry and staff to help address confusion and uncertainty about key parts of our premarket review, clinical trial programs, and how we make benefit-risk determinations.
And it was also clear that new reviewers were not getting the training they deserved – the kind of training that contributes to a more predictable review process. So we have launched a new training program to enhance their skills and make their reports more consistent.
As a result of these changes and more, FDA is already starting to make progress in improving its performance.
But our vision extends beyond fixing the individual spots in the pipeline that may be broken or backed up.
We’re also looking at the system as a whole, and analyzing how projects move from concept to commercialization, to see if we can find additional ways to reduce the amount of time and expense it takes for medical devices to reach the people they can benefit.
Yesterday, some of you may have heard Steve Ondra from the White House Office of Science and Technology Policy who talked about one of the ways the FDA is working to do this.
What they’ve done is assemble a team of entrepreneurs to place in residence at the FDA. These are external experts in developing medical devices, improving business processes, and information technology who will work day-to-day with FDA staff and leadership.
Their goal, in three to six months, is to build an early working version of what we call the "Innovation Pathway" – a streamlined regulatory pathway for breakthrough medical devices.
To give you another example, FDA is working with Medicare and Medicaid to establish a process for doing premarket evaluations at the same time to reduce the time and uncertainty surrounding coverage decisions for these programs.
There is plenty of room for improvement, and we continue to look for new ways to make the review process as effective and consistent as possible. But ultimately, we cannot make real progress through changes in policies and processes alone. It will also take additional resources, and that means user fees.
We have already seen this work with prescription drugs. Before the prescription drug user fee program, the drug industry argued that the US lagged behind Europe in getting medicines to market. They called it the drug lag.
Now, with additional resources, we are frequently the first country to approve drugs. The initial program cut review times in half. And additional user fees 10 years ago cut approval times by another 50 percent.
We can do the same for medical devices. And I encourage you to work with the FDA to come together around a plan for additional resources that also holds us accountable for the improvements we’ve promised.
At the heart of all these efforts is a commitment to make sure that the American people have access to the best care possible.
And we took another historic step toward that goal last year when President Obama signed the Affordable Care Act, a law which will mean that more Americans than ever before can get the care – including innovations from your companies – they need to stay healthy and thrive.
Already, we have achieved a great deal together–the result of a strong partnership between the government and the industry that continues to hold great promise.
Going forward, we will continue implementing changes, soliciting feedback, and seeking out additional areas in need of reform. Your active engagement is vital.
We recognize that meeting FDA standards is not easy, but it is clear to me that America continues to lead as an innovator in medical technology – not in spite of our tough standards but because of tough standards.
We are committed to working with you to make sure we are in the best position to apply those standards as effectively transparently and predictably as possible.
Thank you again for inviting me to be here today, but more importantly for your commitment to innovate, improve lives, and invest in our future.