[Congressional Record (Bound Edition), Volume 162 (2016), Part 3]
[Senate]
[Pages 4300-4301]
[From the U.S. 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 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,

[[Page 4301]]

     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.

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