Give Kids A Chance Act of 2024

Floor Speech

Mr. Speaker, I rise today in support of H.R. 3433, the Give Kids a Chance Act, sponsored by Representatives McCaul and Eshoo.

This bill includes several strong bipartisan pieces of legislation, and I am pleased that our Republican colleagues agreed to work with us on advancing important policies.

This legislation will help expand access to care for patients with rare diseases and complex medical needs, increase research and development into rare pediatric diseases, and improve regulatory certainty.

This bill will help in our efforts to bring new treatments to pediatric patients with more advanced forms of cancer. It also includes important sections of H.R. 6664, Representative Eshoo's bill, the Innovation in Pediatric Drugs Act. Specifically, it gives the Food and Drug Administration new enforcement authority to take action against companies that do not conduct required studies in pediatric patients.

The bill also includes critical language introduced by Representative Matsui as part of H.R. 7383, the Retaining Access and Restoring Exclusivity Act, or RARE Act, and this will clarify FDA's long-held treatment of orphan drug exclusivity and bring new treatments to more patients suffering from rare diseases. These provisions all advance our goals of accelerating the development of novel, safe, and effective treatments and improving outcomes for patients.

These bills are going to make a difference, but I remain disappointed that my Republican colleagues have been unwilling to consider necessary changes to require drug manufacturers to study their approved rare disease drugs in pediatric populations.

It is disappointing that my Republican colleagues refuse to hold drug manufacturers' feet to the fire and have decided to move forward with a long-term reauthorization of the priority review voucher program, or PRV, without requiring manufacturers to study rare disease drugs in pediatric patients.

I have been consistent in my belief that we need reforms to the PRV program. Unfortunately, we still have not seen the compelling evidence that this program is functioning how Congress intended it to. That is why I am pleased that the bill includes a requirement for the Government Accountability Office to conduct a new study and report on the effectiveness of the program in attaining our original intent. Previous reports from GAO on the program, and continued research from academics, show that there is little evidence that it incentivized the products Congress intended to help come to market.

I continue to believe that additional guardrails are needed to better target the intent of the program, but despite these concerns, I am pleased that this bill includes important provisions to ensure that our medical product supply chain can be strengthened by working with international partners that believe in both tolerance and respect for every person as well as advancement of science and medicine. I look forward to working with our Republican colleagues to ensure FDA receives the funding necessary to implement this policy and establish an FDA office in Israel.

I am also pleased that this legislation provides the Health Resources and Services Administration the authority to modernize the organ transplant system. This system is lifesaving for many Americans, and I am glad that we can continue to support these much-needed reform efforts.

I believe that we could have achieved more for patients in this legislation.

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Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I reserve the balance of my time.
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Mr. PALLONE. Mr. Speaker, obviously, this bill does a lot to help childhood disorders. It is a very important bill, and I urge that it be passed on a bipartisan basis.

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