Tsunami Warning, Education, and Research Act

Floor Speech

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Mr. ROBERTS. Mr. President, I have some good news. Today we have before us a legislative package that reflects 2 years of work for the Health, Education, Labor, and Pensions Committee.

When we first embarked on this process, the goal was to find ways to spur innovation and reduce the time it takes for new therapies and treatments to get from the research bench to the bedside for patients.

The bill is the 21st Century Cures Act, which includes--I am going to repeat this several times--true bipartisan victories for patients in our health care system.

Throughout my time in Congress, I have been a consistent supporter of funding for the National Institutes of Health, or NIH, to fulfill our commitment to prioritizing biomedical research and innovation. NIH research returns priceless benefits, giving health care providers new tools and drugs to heal and give hope to individuals. The benefits of this research investment to Kansans back home have been direct and personal.

Back in 2012, the University of Kansas Cancer Center received a National Cancer Institute designation, or an NCI designation. These centers are major players in research and development for cancer treatment and prevention.

The legislation we will be voting on today or tomorrow--or at the very least next week--does commit an additional $1.8 billion for Vice President Biden's Cancer Moonshot. This will not only help the University of Kansas as they continue to push toward a comprehensive cancer center designation, but it will help all Americans who stand to benefit as we work to end the fight against cancer.

In addition to research funding, this bill includes some provisions I authored along with Senator Klobuchar to improve and increase transparency in the review and approval of processes for medical devices. Specifically, the bill does this. It encourages the FDA, or the Food and Drug Administration, to accept international consensus standards to provide more predictability for innovators. Second, it makes improvements to the advisory committee selection process in an effort to provide more transparency. It provides a technical correction to establish a process by which the Food and Drug Administration may remove certain products from the class I device reserve list if they think a premarket review is no longer necessary to prove reasonable assurances of safety and effectiveness. Senators Isakson, Casey, and Roberts' priorities seek to provide more certainty for FDA review of combination products and therapies that do not fit neatly into simply a drug or device.

The legislation also includes important reforms to our mental health system based largely on a bill the HELP Committee passed earlier this year. With this section of the bill, we seek to clarify and improve our mental health parity laws. We reauthorized the substance abuse and mental health block grants. We promote evidence-based practices to ensure we are utilizing our scarce resources on programs that work and not continuing to fund what doesn't work. We reauthorized the Garrett Lee Smith Memorial Act for suicide prevention and intervention and the National Child Traumatic Stress Initiative.

There is a lot more work to be done, obviously, to address the deficiencies in our current system, but this bipartisan bill is certainly a good step in the right direction toward improving access to mental health services and eliminating the stigma of seeking treatment.

Finally, the 21st Century Cures Act includes numerous priorities that my colleagues on the Finance Committee and I have been working on for several years. One provision I was proud to support in committee extends the Rural Community Hospital Demonstration Program for another 5 years. As our rural hospitals continue to try and make ends meet, this program helps what we call ``tweener'' hospitals survive.

Hospitals that do not qualify as critical access hospitals would not survive under the current Medicare payment system. It is a critical program that benefits Kansans in Junction City, Ulysses, and Fort Scott by keeping their hospital and access care open.

There is more rural relief. Senators Thune, Crapo, and I have championed a provision to protect rural access to durable medical equipment under the Competitive Bidding Program. We would have liked to have seen a more permanent solution. However, this bill delays applying competitively bid prices of rural areas and requires the Department of Health and Human Services to take into account stakeholder input as well as average travel distance, volume of items, services furnished, and the number of suppliers in these areas when determining adjustments in setting bid prices.

I have the privilege of being the cochairman of the Senate Rural Health Caucus. I know how critically important these and other pieces of the package are for our beleaguered rural health care system. There is no question that we have many challenges ahead. While this package may not be a silver bullet to ensure cures for all that ails us, it sets priorities in research, cancer, cancer precision medicine, regenerative medicine, and heartbreaking diseases like Alzheimer's through the BRAIN Initiative. We all know someone affected by these dreaded diseases. It also makes significant changes in how these new therapies are evaluated, hopefully approved, and delivered to patients, providing more tools in the medicine cabinet that will improve many lives.

Advances in medical research benefit us all, and this bill does just that.

I wish to make a comment with regard to previous discussions of this bill on the floor of the Senate.

Unfortunately, a very small minority of my colleagues want to criticize and even villainize this legislation and those who worked so hard on it, which is terribly disappointing to me. With the passage of this bill, both Republicans and Democrats can take pride in putting together and working toward a bipartisan bill that lives up to its name--the 21st Century Cures Act. I regret the tone of the debate that took place with regard to this bill and the personal comments that were made.

I will remind my colleagues that there is a rule XIX that the distinguished Presiding Officer can invoke at any time and any Senator can ask that a Senator's words be taken down under rule XIX. I only say it so that we can look upon a bipartisan bill like this and say: Look at what we have done. Let's be proud of it and certainly not get into the mud with regard to any personal comments.

I urge my colleagues to advance research, advance the development treatments, and support this bill. It is a good bill. It is a bipartisan bill that we should all be proud of.

I thank the Presiding Officer and yield back.

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