Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following remarks on the House Floor during consideration of H.R. 34, as amended, the 21st Century Cures Act. Pallone was the lead House Democratic negotiator on this legislation:
Over the past two 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’s been a long journey and I want to begin by thanking my colleagues Chairman Upton, and Reps. DeGette and Green 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 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 (NIH), 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 (FDA) 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 ensures 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’m also pleased 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 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 this final product. I’m disappointed that this final 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 being made today. We will hold them to these promises.
The lack of immediate funding for the FDA is of particular concern given the fact that this bill asks FDA to take on significantly more responsibilities that we know are extremely resource intensive.
I’m also concerned the bill removes certain categories of medical software from FDA oversight. This makes it very difficult for FDA in the future to bring software that is used to support or sustain human life back under FDA’s jurisdiction.
I’m also troubled by a new priority review voucher (PRV) program, which will likely require FDA to issue significantly more PRVs. This could pose a major burden on FDA drug reviewers when redeemed and could prevent 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. Though most of the harmful language was taken out, I remain troubled that this bill creates a new designation process under FDA’s accelerated approval pathway.
Now I’m pleased 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’m 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 to individuals with mental illness if the Republicans move forward with their radical plans to repeal the Affordable Care Act, block grant Medicaid, and cut benefits for low income individuals.
I want to again thank all of my Committee colleagues and the staff for their hard work on this legislation. Thank you.
