Milken Institute Global Conference

Thank you, Mike, for that kind introduction [Michael Milken]. And thank you for all that you do for our country. I’m excited to be participating in this conference with so many of America’s brightest minds.

Ladies and gentlemen, the greatest health care system the world has ever known operates right here in America, and the people in this room are a part of it. Our system is great because doctors and nurses, hospitals and clinics, manufacturers and researchers, investors and pharmacists have the freedom to compete to offer the best care.

We have entered a great new era in American medicine. From the moment of conception to the very end of life, we understand more about human health than the medical profession thought possible only a couple of generations ago.

Innovative medical technology—particularly new drugs, devices, and biologics—are giving sick people hope and new chances at life.

Think about how we look at HIV and AIDS. This is a great example of how innovative medicine has transformed millions of peoples’ lives. Twenty years ago, an HIV diagnosis was a death sentence. Today, thanks to medical breakthroughs like anti-retroviral drugs, we are able to sustain life and enhance quality of life for those living with HIV and AIDS.

And my Department is doing some remarkable work with these anti-retroviral drugs in Africa. [Thompson discusses his trips to Africa]. We are blessed to live in America.

Still, as we celebrate our system’s successes, we know that we cannot rest on the achievements of even recent yesterdays. We have to look ahead – not only to new technologies and treatments, but also to how we can best foster the innovation and research needed to bring new technologies and treatments forward. And bring them forward quickly, to more people.

I’m here today to share my vision for how we can improve our system, to speed the time it takes to get the latest medical breakthroughs and innovative products from the lab bench to the bedside.

Let’s look at the problem first. And make no mistake—we do have a problem on our hands. The NIH says it takes from 10 to 15 years for new discoveries to be routinely used. Only 1 in 5,000 compounds that enter preclinical testing make it to U.S. patients. On average, it costs a company $802 million to get one new medicine from the laboratory into the hands of patients in the United States. These figures are shocking and unacceptable.

They are unacceptable because they carry real consequences—major drug and biological product submissions have decreased consistently over the last decade, in spite of our scientific advances. Because of the “process,” good drugs and devices are being held back from Americans who could benefit from them.

Who knows what medical innovations we are missing out on because they are stuck somewhere in the research or approval pipeline? Or worse, who knows what new products aren’t making into the pipeline in the first place because innovative companies find the entire process too daunting or not worth their efforts?

Take genomics for example. The sequencing of the human genome was a remarkable accomplishment and one of the greatest medical breakthroughs of the past few decades. This breakthrough will allow for treatments that can be individually tailored based on a patient’s genetic makeup. Yet have we delivered on the potential of this achievement? Are we seeing an abundance of new tools for individualized treatment approved by the FDA and improving the lives of American patients? I think we can do more.

America has the greatest scientific minds in the world—we have always been the world leader in driving medical breakthroughs—and it is imperative that we keep it that way. We must not accept our current situation as unchangeable.

So what steps can we take to remedy the situation?

First, it begins with research. We need to do a better job of translating research into more FDA-approved products. For me, I’m particularly concerned with research funded by the Federal government at the National Institutes of Health. President Bush has invested heavily in NIH—we just finished doubling its funding. As we increase our expenditures, we want our investment to pay off in more viable products.

NIH has charted a roadmap that lays out a vision for a more efficient and productive system of medical research. It identifies the most compelling opportunities and gaps in biomedical research. By addressing the identified opportunities and gaps, NIH hopes to remove some of the biggest roadblocks that are preventing research findings from producing into tangible benefits for people. I am excited about the work that they will continue to do in the days ahead.

And to complement NIH's work, I support the creation of a national research database. And I know Mike Milken has worked closely with Greg Simon and others to develop a good program—the Patients Helping Doctors program—that will educate patients about the importance of participating in medical research.

I applaud these efforts. I think we can all agree that the basic concept of a patient research database or bio-bank is good. Such a database will improve medical research by providing the resources necessary to examine the relationship between genomics, environmental and lifestyle factors, and health. There aremany issues that we must resolve to make this a reality--including resolving proper standards and ensuring patients' rights to privacy and confidentiality. But I am committed to seeing this through. And I appreciate Faster Cures' vision and their work to try to spur consensus on some of these issues.

Next, we have to examine FDA’s approval process. For many years, FDA had a slow, cumbersome approval process. When I took office, I was surprised to see how difficult it was. I resolved to speed it up, and we have done just that. The average review time for an innovative new drug is now only 6 months, and some have been approved even faster.

We have taken several important steps to make this process more efficient. FDA’s user fee programs have helped reduce the time it takes FDA to review and make an approval decision on a product.

Also, we have improved the approval process for combination products, that is, products that are composed of both drugs and devices. One example is a diabetes infusion pump—an incredible device that’s implanted in the body. New devices such as this one are around the corner. With the Centers for Drugs and Devices at FDA working together, we believe this product will be on the market within a year. An even more dramatic breakthrough, an implantable pump with a biosensor that monitors blood glucose to continuously provide the right amount of insulin is also under development. Traditionally, such sophisticated devices invite bureaucratic logjams and difficult regulatory questions, and they get held up.

However, we have opened a new Office of Combination Products to address some of these problems. This office should help ensure the most efficient review of these products, so that new combination technologies are quickly routed through the correct approval process. And from what I hear, this new office is already improving our timeliness and responsiveness. My hope is that we’ll continue to improve in the years ahead.

But we can do more, and there are many other areas where we must pinpoint inefficiencies. To determine our next steps, we launched last month a Critical Path Initiative at FDA, with the goal of prioritizing the most pressing medical product development programs and identifying needed research. This initiative will help us identify the areas along the critical path that provide the greatest opportunity for rapid improvement and public health benefits and allow the FDA and its partners to bring exciting research developments to the patient’s bedside. Only a concerted effort involving other agencies, academia, and industry will succeed in modernizing the drug, device, and biologics development process.

Medicare also affects this whole process. Because seniors use such a high proportion of America’s drugs and devices, and because 41 million seniors use Medicare, Medicare’s policies greatly affect the entire market. In particular, Medicare’s reimbursement policies affect the process.

With the passage of the Medicare Modernization Act, President Bush and the Congress have helped modernize a system that was desperately in need of reform. The new law will save seniors money on prescription drugs, make more preventive benefits available, and give them more choices in care. It will also help speed up payment for new technologies by requiring the Centers for Medicare and Medicaid Services to meet 9-12 month deadlines for national coverage decisions. This will certainly help, but we must do more to ensure that beneficiaries have rapid access to effective new technologies.

So that’s what’s happening at several Federal agencies—at NIH, FDA, and CMS. But this effort will take more than individual agency efforts. It will require coordination across our entire Federal government.

That’s why I’m proud to announce that I will be forming a new task force to determine steps we can take to accelerate medical technology and innovation. This task force will include some of our government’s best scientific minds—Dr. Julie Gerberding, the head of the Centers for Disease Control and Prevention; Dr. Elias Zerhouni, head of the National Institutes of Health; Dr. Mark McClellan, the former head of the Food and Drug Administration who just took over Medicare; and Dr. Les Crawford, the Acting Commissioner of the FDA.

This task force will examine the difficult questions—why does this take so long? And why does it cost so much? How can we make the system more efficient? Where are the flaws in the system that hold us back?

We are also seeking your input on these issues. In the coming weeks, we will post a notice in the Federal Register, soliciting your comments. And I encourage you to take the time to share your experiences and insights.

Ultimately, the solution to this problem will depend on many more forces besides the Federal government. In fact, you in the private sector will probably do more to drive this change than we in the government will. But it’s my job as HHS Secretary to push all of you to make this a reality. I take this job seriously, and will not settle for anything less than the best for the American people and their health.

Friends, the bottom line is that when it comes to live-saving technology, drugs, and devices, there’s no time to waste. The time is now. We can do this! We can transform the way drugs and devices make their way into the hands of American patients—from concept to approval to implementation to reimbursement.

Thank you again for your efforts and your contributions to our health care system. And thank you for your commitment to make our system stronger and more efficient.

Last Revised: April 29, 2004

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