Speeches & Floor Statements

Floor Speech: Senator Lamar Alexander Remarks on 21st Century Cures

Posted on December 5, 2016

While we are waiting for Senator Murphy, let me salute Senator Kirk for his leadership from the very beginning. He has pointed out to the committee and the Senate that, as the Mayo Clinic has said, regenerative medicine is a “game changer” for stroke victims, for heart disease, and for people with retinal disease.

Thanks to Senator Kirk, Senator Collins, Senator Manchin, and Senator McConnell, we have legislation that takes an important and responsible step forward to recognize the promise of regenerative medicine.

This bill includes $30 million to the National Institutes of Health for clinical trials to support regenerative medicine. Then there are two other provisions in the bill. One of them allows the Food and Drug Administration to make regenerative therapeutic products eligible for the FDA's existing accelerated drug approval pathway. We have had great success over the last four or five years with an accelerated pathway for drugs, similar to what Senators Burr and Bennet and others got enacted into law. We are doing the same thing with combination drugs and devices in this legislation. Now Senator Kirk has added regenerative medicine to the accelerated pathway, and I salute him for that leadership.

The Senator from Illinois is very generous, and I thank him, but I would remind him that he was the persistent agent for the change in support for regenerative medicine. That wasn't easy to do, and he has been the leader, along with others of us who cared about the same thing, in making sure the United States maintains its lead in supercomputing competition around the world.

Senator Murphy, the Senator from Connecticut, is coming. I think what I will do is begin, and when he comes I will stop and let him make his five minutes of remarks and then resume so I don't delay the vote because I know everyone is looking forward to casting a great big “yes” vote in a few minutes.

The U.S. Senate Majority Leader has said more than once in private meetings I attended and on the floor of this body that the 21st Century Cures bill on which we will be voting in a few minutes is the most important legislation Congress will pass this year.

In his address to the nation this past weekend, President Obama urged us to vote for the bill today and tomorrow. “It could help us find a cure for Alzheimer's,” the President said. “It could end cancer as we know it and help those seeking treatment for opioid addiction.” The President continued: “It's an opportunity to save lives and an opportunity we just can't miss.''

Vice President Biden has been telephoning senators urging support for 21st Century Cures because, in the Vice President's words, it is a big step for cancer research and the Cancer Moonshot that is so close to his heart.

Speaker Paul Ryan in the House of Representatives has made 21st Century Cures explicitly a centerpiece of his vision for our country's future, describing it as “bipartisan legislation that would accelerate the discovery, development, and delivery of lifesaving treatments.”

With such bipartisan support from the President of the United States, the Vice President of the United States, the Speaker of the House, the Senate Majority Leader—two Democrats, two Republicans—it is no wonder that on last Wednesday, the House of Representatives approved 21st Century Cures by the overwhelming vote of 392 to 26. 

This legislation holds the promise of improving the life and health of virtually every family in the country.

It will provide $4.8 billion in a one-time surge of funding for biomedical research in a time of breathtaking opportunity.

It will advance Vice President Biden's Cancer Moonshot to find cures for cancer and President Obama's Precision Medicine Initiative, as well as the BRAIN Initiative.

It will help move safe and effective treatments and cures through the development and regulatory process more rapidly, and it will lower costs, making medicines available sooner and hopefully also at lower costs to patients.

It will provide $1 billion in grants to help deal with the raging opioid epidemic.

It includes legislation to help the one in five adults in this country suffering from a mental illness, help them receive treatment by updating many of our country's mental health programs for the first time in a decade.

It will improve health information technology for doctors who are eager to get rid of the over documentation of hospitals and their patients and help get the nation's electronic health records system out of the ditch.

From a taxpayer's point of view, it does all of these things in a fiscally responsible way by reducing other spending to pay for every penny of the $6.3 billion cost.

I see the Senator from Connecticut on the floor, so I would like to suspend my remarks for five minutes so that he can make his, and then I would ask unanimous consent that the totality of my remarks follow his remarks. 

nonaddictive medicines to manage pain. An even more effective antidote than the $1 billion we would be authorizing by our votes today. These truly would be miracles.

The bill has taken more than two years to assemble both in the Senate and the House. There have been major differences of opinion, but the resolution of those differences—thanks to Senator Murray and many other senators—has been bipartisan every step of the way. We saw that on display in the work of the President, the Vice President, the Speaker of the House, and the Senate Majority Leader. We saw it in the House with its vote of 392 to 26 last week, thanks especially to the leadership of Chairman Upton, Ranking Member Pallone, and Representative DeGette. We saw it in our Senate health committee, where we approved 19 bills that include 50 proposals, and every one with both a Democratic and Republican sponsor, except for one bill offered solely by Senator Murray, who is the ranking Democratic member of our committee.

We have a diverse committee of 22 members—that would be an understatement, actually—some of the most liberal members and some of the most conservative members. But when our committee considered these 19 bills during our three markups held over several months, the largest number of votes against any one of these 19 bipartisan bills was two. Let me say that again. The largest number of recorded votes against any one of these 19 bipartisan bills was two in our committee of 22.

Here is what some of those 19 bipartisan bills—again, approved unanimously or by a wide margin—would do to help move safe and effective treatments and cures more rapidly through the regulatory process and into patients' medicine cabinets and into doctors' offices.

For example, Senators Bennet, Warren, Burr, and Hatch’s legislation would allow researchers to use their own data from previously approved therapies when they submit for review a treatment or cure for serious rare genetic diseases, like Duchenne's, a rare kind of muscular dystrophy that could impact children as young as 3.

Senators Burr and Franken's legislation will help to bring innovative medical devices--such as artificial knees, insulin pumps, and heart stents--to patients more quickly by getting rid of unnecessary burdens in medical device evaluations and streamlining the review process for clinical trials.

Senators Baldwin and Collins had a bill to improve opportunities for our young researchers, essential to advancing biomedical research.

Senator Kirk just talked about his legislation with Bennet, Hatch, Murkowski, Isakson, and Collins to improve rehabilitation research and help the approximately 800,000 Americans who suffer a stroke each year.

Senators Isakson, Murphy, Casey, Wicker, and Vitter will help advance our understanding of neurological diseases.

Senator Murray, as I mentioned earlier, will clarify that the FDA requires cleaning and validation data for reusable medical devices.

Senators Murray, Hatch, Bennet, Cassidy and Whitehouse’s bill will improve health information technology for doctors and their patients. We had six hearings on medical information technology programs in a ditch. We think we are helping to get them out of the ditch. We have been working with the Obama administration to do that, and I look forward to working with the Trump administration to continue that.

            Senators Burr, Bennet, Hatch, and Donnelly would speed safe breakthrough devices, putting senior people in charge of the review process.

Senators Casey, Isakson, Brown, and Kirk's legislation: If you are the parent of a child with a rare disease like brain cancer, their bill would increase the likelihood that your child will be able to take a drug that will help by giving a drug company that develops a drug for such a disease a voucher they could keep or sell that would speed up the review of another drug.

One may say this is getting boring. This is too long. It is not boring to the millions of Americans who stand to benefit from this, and it is exactly the kind of work we ought to be doing in the United States Senate and what the American people would like to see us do more of.

Senator Murray, Congress added $2 billion a year to the $32 billion budget of the National Institutes of Health, which could total $20 billion over 10 years.

Then, the Senate Appropriations Committee recommended another $2 billion increase for the next fiscal year, 2017, which could total another $20 billion over 10 years. This 21st Century Cures legislation adds $4.8 billion in a surge of one-time spending for the National Institutes of Health on top of the regular appropriated money toward key objectives: $1.8 billion for the Cancer Moonshot, $1.4 billion for precision medicine, $1.6 for the BRAIN Initiative, and it adds $1 billion for State grants to help States fight the opioid abuse epidemic. I believe that for every state represented by a senator here tonight, the opioid epidemic is on the front pages of the newspapers. It adds $500 million for the Food and Drug Administration. 21st Century Cures also gives the National Institutes of Health $30 million for clinical trials to support regenerative medicine, which the Mayo Clinic has described as a “game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair.'' It gives the FDA authority to allow regenerative therapeutic products to be eligible for FDA's existing accelerated drug approval pathway.

I want to acknowledge the work of Speaker Ryan and Leader McConnell in designing a way to secure funding that both Democrats and Republicans can accept. That is not always easy. For those concerned about additional spending—often on our side of the aisle—Speaker Ryan and House Budget Chairman Tom Price made sure the funding is one time, not mandatory, paid for, and approved each year by Appropriations Committees. It doesn't add one penny to the overall budget because for every increase in the discretionary budget, we reduce the same amount in the mandatory ledger.

For those who worry that Congress might not approve the $6.3 billion in additional spending in later years—I have heard a little of that from the other side of the aisle—my answer is that the best way to ensure the money is spent in the following years is a big vote today and tomorrow when we finally pass the bill, just as the House did last week. 

In conclusion, it will be hard to explain why you voted to spend $6.3 billion for cancer, the Precision Medicine Initiative, and opioids this year but then voted not to spend it next year, and the legislation provides that the money cannot be diverted for any other purpose than what we vote for today and tomorrow.

In addition, this year's portion of Cures—including one-half billion for opioid grants—is included in the continuing resolution that we will vote on later this week.

This is the kind of lasting legacy the President of the United States and our Congress can be proud of. The next administration or the next Congress will not be repealing this law because we have taken the time to work out our differences and create a consensus of support. We did this at this time last year with an equally complicated bill to fix No Child Left Behind, which, despite its complexities, received 85 votes in this body. When he signed it, the President called it a “Christmas miracle.”

The 21st Century Cures bill will present President Obama with another Christmas miracle, one that will help virtually every family. When we pass this legislation, the real winners will be the American families whose lives will be improved by this bipartisan legislation.

Mr. President, I yield the floor.