[Congressional Record Volume 161, Number 42 (Thursday, March 12, 2015)]
[Senate]
[Pages S1490-S1491]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CONTINUING AMERICA'S LEADERSHIP IN MEDICAL INNOVATION FOR PATIENTS
Mr. ALEXANDER. Mr. President, I ask unanimous consent to have printed
in the Record a copy of my remarks at the Senate Health, Education,
Labor and Pensions Committee hearing this week.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Continuing America's Leadership in Medical Innovation for Patients
We've got three major objectives in this committee: Fixing
No Child Left Behind, Reauthorizing the Higher Education Act,
and third--one we're all looking forward to without
exception--improving biomedical innovation, including the
Food and Drug Administration (FDA) and the National
Institutes of Health (NIH).
Today is the first hearing Ranking Member Murray and I are
holding on our bipartisan initiative to examine how we get
drugs, devices and treatments from the discovery process
through the regulatory process into our medicine cabinets and
doctors' offices.
Today discoveries supported by NIH often do not come to
FDA's door for six, eight, ten, or even twelve years. And the
average cost to get a single drug from the laboratory through
the approval process to the medicine cabinet is, according to
some estimates, about $1 billion. Other estimates say it's
double that or even more.
This initiative builds on work the committee has done--
legislation was passed in 1997 and as recently as 2012--to
try to get at the same goal of speeding up review and
approval of drugs and devices while still ensuring they are
safe.
This is a subject that has a lot of interest.
President Obama this year announced his new Precision
Medicine Initiative, saying: ``21st century businesses will
rely on American science, technology, research and
development. I want the country that eliminated polio and
mapped the human genome to lead a new era of medicine--one
that delivers the right treatment at the right time. In some
patients with cystic fibrosis, this approach has reversed a
disease once thought unstoppable.''
In the House, Energy and Commerce Chairman Fred Upton and
Representative Diana Degette have been working on parallel
tracks on their 21st Century Cures initiative to accelerate
the pace of cures in America.
In late January, Sen. Burr and I released a report titled
``Innovation for Healthier
[[Page S1491]]
Americans'' that examined the process we have in place today
for drug and device development.
We have received over 80 comments already, and have shared
those with the staff of all members on the committee.
Our committee also has a bipartisan staff working group
that has been meeting for around a month now, learning more
about the key agencies involved in biomedical research and
development.
We have with us today Dr. Francis Collins, Director of the
National Institutes of Health, which funds and enables much
of the early stage research that leads to medical
breakthroughs. And Dr. Margaret Hamburg, the head of the Food
and Drug Administration, which regulates all the medical
products we come in contact with.
Dr. Collins wrote in 2013 that: ``Drugs exist for only
about 250 of the more than 4,400 conditions with defined
molecular causes. And it takes far too long and far too much
money to get a new drug into our medicine cabinets. This is
an old problem that cries out for new and creative
solutions.''
Since Dr. Collins wrote that, the number of conditions with
defined molecular causes has increased to more than 5,400,
yet the number of new drugs approved has not kept pace with
these discoveries.
Dr. Hamburg has said that ``we are left relying on the 20th
century approaches for the review, approval and oversight of
the treatments and cures of the 21st century.''
So today's hearing is a perfect place for us to start--with
the heads of these two critical agencies, both of whom have
sounded the alarm on our existing process for drug and device
development.
This work will affect every single American--from a very
ill patient who has run out of treatment options and is
counting on the most cutting-edge drug, to an active child
with asthma who's hoping to run faster and farther with the
aid of a new drug.
I look forward to hearing from the witnesses more about
their thoughts on these five issues that Senator Burr and I
identified in our report: First, it costs too much to bring
medical products through the pipeline to patients. Second, as
science and technology advance, the discovery and development
process takes too long for medical products to make their way
to patients. Third, FDA's responsibilities have grown to
include many activities unrelated to the core function of
regulating medical products to advance the public health.
Fourth, the disparity in scientific knowledge at FDA and the
fast pace of biomedical innovation are slowing, and in some
cases, stifling innovation in American medicine. Fifth, a
working FDA is essential to continuing biomedical innovation
in the United States and maintaining America's global
leadership in medical innovation.
In the words of Andrew Eschenbach, the former Commissioner
of the FDA and Director of the National Cancer Institute:
``We stand on the cusp of a revolution in health care.
Advances in molecular medicine will allow us to develop
powerful new treatments that can cure or even prevent
diseases like Alzheimer's and cancer. Tomorrow's high-tech
cures can also slash health-care costs and eliminate
ineffective treatments.''
I look forward to taking the first step toward addressing
these important issues. If we do it right, our work here will
help improve the lives of every single American.
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