Washington, DC – Energy and Commerce Committee Republican Leader Greg Walden (R-OR) delivered remarks at Health Subcommittee legislative hearing entitled, “Improving Access to Care: Legislation to Reauthorize Key Public Health Programs.”
As Prepared for Delivery
Madam Chairwoman, I am glad we are convening this hearing to discuss the reauthorization of several important public health programs, many of which face uncertainty as their authorizations have either lapsed or will expire in just a matter of months. Reauthorizing the funding of these public health programs could be life-saving for many Americans and because of that it is critical that we swiftly move these bills.
The first bill, H.R. 2075, the School-Based Health Centers Reauthorization Act of 2019, sponsored by Reps. Sarbanes, Upton, and Tonko, reauthorizes funding for the school-based health center program, which supports health centers operating as a partnership between a school and community health organizations in order to provide quality health care services to students. H.R. 4078, the EARLY Act Reauthorization of 2019, sponsored by Reps. Wasserman Schultz and Brooks reauthorizes programs related to breast cancer outreach and education initiatives, along with survivor support services at the Centers for Disease Control and Prevention (CDC). H.R. 4764, the TRANSPLANT Act of 2019, spearheaded by Reps. Matsui and Bilirakis, reauthorizes the C.W. “Bill” Young Cell Transplantation Program, which provides critical support and life-saving treatment to patients in need of bone marrow or umbilical cord blood transplants.
There are approximately 7,000 known rare diseases affecting an estimated 30 million people. It is also estimated that about half of these diseases affect children. That is why I am glad that we are also considering H.R. 4439, the Creating Hope Reauthorization Act. This bipartisan legislation will make the priority review voucher (PRV) program permanent for rare pediatric diseases. The PRV was first created in 2012 with the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) to incentivize the development of therapies to treat rare pediatric diseases. While progress has been made in the development of pediatric therapies – in fact, 22 therapies have been approved for the treatment of 18 rare pediatric diseases since the inception of the pediatric PRV program – we still have a long way to go. Nearly 95-percent of all rare diseases do not have an FDA-approved treatment, leaving many patients without options.
Research and development for rare disease therapies is often scarce because each drug is only intended to serve a small number of patients, meaning the opportunity to earn a profit is limited. Drug development is extremely costly and time-intensive, often requiring billions of dollars and nearly a decade before receiving FDA approval – if it makes it through the approval process at all. The permanent reauthorization of the pediatric PRV program would provide some certainty to drug developers considering whether to invest in therapies for rare pediatric diseases as they evaluate the feasibility of devoting significant resources to products that may not provide a return on the significant investment given the limited population of patients, but that could be life-changing for those that receive them.
I thank the witnesses for being here today and look forward to hearing their testimony. I hope we can move these commonsense, bipartisan bills through the mark up process as quickly as possible. I yield back.