REMARKS BY:
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TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES
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PLACE:
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Secretary Thompson’s Remarks As Prepared for the Milken Institute's Global Conference,
Los Angeles, CA
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DATE:
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April 26, 2004
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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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