[Congressional Record Volume 162, Number 57 (Thursday, April 14, 2016)]
[Senate]
[Pages S2093-S2094]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SENATE HEALTH COMMITTEE EXECUTIVE SESSION ON INNOVATION AGENDA
Mr. ALEXANDER. Madam President, I ask unanimous consent that a copy
of my remarks at the Senate Health Committee's third executive session
on its biomedical innovation agenda be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Senate Health Committee Executive Session on Innovation Agenda
This is our third and final markup of legislation that is
part of our innovation, or ``cures,'' agenda--that is, our
effort to take advantage of this exciting time in science and
enable safe treatments, drugs, and devices to reach patients
more quickly.
Today's markup completes action on about 50 bipartisan
proposals this committee has been working on for more than a
year--with 10 hearings, five staff working groups that have
held more than 100 meetings. When we are finished today,
these proposals will together form a companion to 21st
Century Cures Act, which passed the House 344-77 last year,
and a vehicle for the president's Precision Medicine
Initiative and Cancer Moonshot.
If we succeed, this will be the most important bill signed
into law this year.
Why do I say that?
Here's one reason: 6-year-old Californian Rylie Rahall,
diagnosed with a genetic disorder called Ataxia-
Telangiectasia or A-T, so rare--according to NIH--that it
affects between 1 out of 40,000 and 1 out of 100,000.
A bill we're voting on today will support the president's
Precision Medicine Initiative to map 1 million genomes to
help researchers tailor treatments to genetic variations and
find cures for diseases, including rare diseases like A-T,
and help children like Rylie.
Rylie's mom, Erica, says:
``At the time Rylie was diagnosed, I felt more helpless
than hopeful. . . . There are no drugs. There is no cure.
There is nothing to stop this disease and nothing you can do
to save your child. . . . Five years later all of that is
changing. There is more research than ever happening. We are
closer than ever to clinical trials . . . Hopeful.''
Here's another reason:
In a floor speech in 2013, Senator Isakson talked about
battling a superbug, an infection that runs out of control
and resists treatment by common antibiotics. We are voting
today on a bill by senators Hatch and Bennet to shorten the
development of treatments for superbugs.
And another reason: A 2012 bill sponsored by Senators Burr,
Bennet, and Hatch to expedite the FDA review process for
breakthrough drugs has been very successful, leading to 118
drugs designated as breakthrough, including 39 approvals,
including the first drug ever to actually cure some forms of
Cystic Fibrosis. This committee passed similar legislation in
March for breakthrough devices.
One more reason: we've heard from doctors that they spend
half their time on paperwork, and from patients who lug boxes
of medical records from appointment to appointment. This
committee unanimously passed legislation to reduce the
documentation burden and improve the flow of information so
doctors can spend more time with patients, and patients can
have easier access to their health information.
This committee has passed--by voice vote or with
overwhelming support--14 bills made up of 30 bipartisan
proposals; bills that will mean better pacemakers for
Americans with heart conditions, better rehabilitation for
stroke victims, more young researchers entering the medical
field, and better access for doctors to their patients'
medical records.
By the time we finish today, 16 of this committee's 22
members will have sponsored one of these bills. Some have
sponsored several.
Today we are voting on five bills:
A bill by Senator Murray and myself to help the FDA and the
NIH attract and retain top talent, which Dr. Collins and Dr.
Califf say is their top priority.
The bill by Sens. Hatch and Bennet to shorten the
development time for superbug treatments.
The bill by Senator Murray and myself to support the
president's Precision Medicine Initiative, to map 1 million
genomes and make the information available to researchers who
will share their research.
A bill by Senator Collins, Kirk, Baldwin, Murray, and
myself that requires NIH to submit a strategic plan to
Congress; and ensures that scientists are including women and
minorities in their research.
A bill by Senator Murray and myself to allow NIH
researchers to spend more time finding lifesaving treatments
and cures and less time on paperwork.
I look forward to moving these bills to the floor.
Senator Murray and I are making progress on an ``NIH
Innovation Fund'' to provide a
[[Page S2094]]
one-time funding surge for NIH priorities including:
Precision Medicine, Cancer Moonshot, the Brain Initiative,
Young Investigator Corps, and Big Biothink Awards.
With its 21st Century Cures Act, the House voted 344 to 77
to provide $8.8 billion in paid-for mandatory funding to
support such NIH priorities. We continue working on finding
an amount that the House will agree to and the president will
sign that we can responsibly pay for in a bipartisan way. We
have consulted with Senator Hatch, the chairman of the Senate
Finance Committee. I discussed it with Senator Wyden in a
meeting with Secretary Burwell. And I've talked with a number
of committee members. I hope we'll be able to share an
agreement with committee members soon.
I would like to take the proposals we've passed here, along
with a bipartisan agreement on the NIH Innovation Fund with
Senator Murray, and put them in Senator McConnell's hands as
the Senate's contribution to a 21 Century Cures Act.
We'll have an opportunity for more debate on the floor,
including:
On a proposal by Senators Kirk, Manchin, and Collins to
create a first-time conditional approval for regenerative
medicine treatments.
Improving monitoring of medical devices. Senator Murray
strongly urged this and it is a top priority for Dr. Califf.
The issue of lab developed tests, which are vitally
important to get right to ensure precision medicine and
cancer moonshot are a success.
Last year, the most important bill signed into law fixed No
Child Left Behind and affected 50 million children in 100,000
schools.
This year, I believe the most important bill will take
advantage of this exciting time in science to improve the
health of virtually every American.
The House of Representatives has done its job by a margin
of 344 to 77.
The president has proposed his initiatives.
I'm hopeful we can take this to the Senate floor,
conference with the House, and send a bill to the president.
Sometimes we get caught up in bill numbers and sections,
but as we finish our work, we ought to focus on people, like
Rylie Rahall, or on Douglas Oliver, a Nashville resident who
as recently as August was legally blind due to an incurable
form of macular degeneration, but who, after participating in
a clinical trial where doctors injected stem cells from his
hip into his eye, now has perfect enough vision to read about
what we're doing here in the HELP committee and sends us
emails about his experience to help improve our work.
____________________