Tsunami Warning, Education, and Research Act of 2015

Floor Speech

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Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, over the past 2 years, my colleagues and I on the Energy and Commerce Committee have worked to craft the 21st Century Cures Act with the goal of getting new treatments and cures to the people who need them the most. It has been a long journey, and I want to thank my colleagues, Chairman Upton, Representatives DeGette and Gene Green of Texas for their commitment to this important legislation.

This is not a perfect bill, but, after much consideration, I believe the benefits outweigh my concerns, and I fully support its passage. This final bill includes many provisions that my Democratic colleagues and I, as well as the administration, fought hard to have included.

The bill provides new funding for the National Institutes of Health, the President's Precision Medicine Initiative, and the Vice President's Cancer Moonshot initiative. It also provides new resources for the Food and Drug Administration and grants for States currently battling the opioid abuse crisis.

This final legislation also includes important policy changes that break down the research silos that have existed for years. The bill includes data sharing among NIH-supported scientists and increases the number of racial and ethnic minorities and women that are included in NIH-funded clinical trials.

These important changes will allow the entire scientific community to learn lessons from this critical NIH-funded research and will strengthen research for diverse populations.

I am also pleased, Mr. Speaker, that the bill includes a new FDA grant program to study the process of continuous drug manufacturing. This innovative process will allow for more effective drug production without sacrificing quality. The bill also includes important hiring provisions to help the FDA recruit and retain the best and the brightest and policies to move us closer to ensuring we have interoperable electronic health records, which are critical to reducing costs and improving care.

As I said, this is not a perfect bill, and I have some concerns with the final product. I am disappointed that the bill does not contain guaranteed funding. Instead, we must ensure each year that the Appropriations Committee and the Republican majority lives up to the promises they make today, and we will hold them to these promises. The lack of immediate funding for the FDA is a particular concern given the fact that this bill asks the FDA to take on significantly more responsibilities that we know are extremely resource intensive.

I am also concerned that the bill removes certain categories of medical software from FDA oversight. This makes it difficult for FDA, in the future, to bring software that is used to support or sustain human life back under FDA's jurisdiction.

I am also troubled by the new priority review voucher program which will likely require the FDA to issue significantly more PRVs. This could pose a burden on FDA drug reviewers when redeemed and could prevent the FDA from being able to prioritize its review of drugs based on public health priorities.

The bill includes new language added without full consideration by the House or Senate regarding FDA oversight of regenerative medicine products.

While most of the harmful language was taken out, I do remain troubled that the bill creates a new designation process under FDA's accelerated approval pathway.

I am pleased, Mr. Speaker, that this package includes the Helping Families in Mental Health Crisis Act. This is a helpful step towards the more substantial reforms our broken mental health system needs.

I am specifically proud that the bill expands an important set of Medicaid benefits to kids receiving inpatient psychiatric treatment. However, let's be clear, the benefits of the mental health bill will be far outweighed by the catastrophic harm caused by individuals with mental illness if the Republicans move forward with their radical plans to repeal the Affordable Care Act or block grants for Medicaid or cut benefits for low-income individuals.

Again, on balance, this is a good bill. I fully support it. I want to thank all of my committee colleagues and their staff for their hard work on this legislation.

I reserve the balance of my time.

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Mr. PALLONE. I yield myself such time as I may consume.

Mr. Speaker, I would like to conclude by referencing the Statement of Administration Policy because I believe it reflects my position for the most part.

If I could just read some sections--I am not reading the whole thing--it says:

``The Administration strongly supports passage of the bipartisan House Amendment to the Senate Amendment to H.R. 34, the 21st Century Cures Act, which dedicates more than $6 billion to implement key priorities such as the President's proposal to combat the heroin and prescription opioid epidemic; the Vice President's Cancer Moonshot; and the President's signature biomedical research initiatives, the Precision Medicine and Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiatives. It also takes important steps to improve mental health . . .

``The Administration is committed to taking immediate action to lay the groundwork to ensure that the funds in the bill would be disbursed quickly and effectively so we can begin to address these important public health challenges . . .

``There are . . . provisions in the bill that raise concerns, but that have been modified from previous versions to help address those concerns, such as provisions that allow for the marketing of drugs to payers for off-label uses. In addition, a number of effective dates will be challenging to meet, especially without additional administrative funding . . .

``That said, this legislation offers advances in health that far outweigh these concerns. As such, the Administration strongly supports passage of the House Amendment to the Senate Amendment to H.R. 34, the 21st Century Cures Act.''

Let me just say also in conclusion, I believe that this is an important piece of legislation that we need to pass, and I would hope that the Senate would take it up and pass it, and, obviously, the administration or the President will sign it.

From the very beginning, when we passed the 21st Century Cures Act, I thought that it would make important strides in actually dealing with those diseases for which we have not made a lot of progress in terms of advancing and finding cures, but, at the same time, I am happy that this legislation has now become a little more of a catch-all or a lot more of a catch-all, if you will, because it is addressing funding for opioids. Many of us know we passed an opioid package that the President signed in July, but it is not funded. So there will be funding for that bill now.

As far as the mental health reforms, our committee spent a tremendous amount of time over the last 2 years trying to address that legislation. We passed a bill here in the House. Again, I am happy that this is included because the kinds of reforms that were in that bill are now in this bill, and I think they are important strides in terms of addressing some of the mental health concerns that we have in this country.

The same is true for Cancer Moonshot. The President spent a lot of time, the Vice President as well, and this will make at least a down payment on that. So, overall, this is a good bill. I support it. I urge my colleagues to support it as well.

Mr. Speaker, I yield back the balance of my time.

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