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Chairman Alexander’s Prepared Remarks for the Senate Health Committee’s Final Meeting on Innovation 2016

WASHINGTON, April 6 – Below are the prepared remarks from Senate health committee Chairman Lamar Alexander (R-Tenn.) for today’s executive session:

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, 5 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 5 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 life-saving 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 21st 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.