    [Congressional Record Volume 171, Number 37 (Tuesday, February 25, 2025)]
    [Senate]
    [Page S1347]
    From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

          By Mr. REED (for himself and Mrs. Capito):
      S. 705. A bill to amend the Federal Food, Drug, and Cosmetic Act with
    respect to molecularly targeted pediatric cancer investigations, and
    for other purposes; to the Committee on Health, Education, Labor, and
    Pensions.
      Mr. REED. Mr. President, today, I am joining Senator Capito to
    introduce the Innovation in Pediatric Drugs Act of 2025 in order to
    improve access to needed therapies for children.
      Children are not just small adults. Drugs affect their developing
    bodies differently, so new treatments need to be studied carefully to
    ensure that they are appropriately prescribed and that dosages are
    properly adjusted. Additionally, drugs that are designed to treat a
    specific condition in adults may have enormous benefits in treating
    completely different illnesses in kids. But research is needed to
    unlock these potentially lifesaving possibilities.
      Unfortunately, drug development still leaves children behind. The
    legislation we are introducing today would help speed therapies to
    children who need them by making needed changes to the Best
    Pharmaceuticals for Children Act, BPCA, and the Pediatric Research
    Equity Act, PREA--two laws that encourage and require the study of
    drugs in children.
      Data resulting from BPCA and PREA studies are added to drug labels to
    give parents and providers essential information on the safety and
    efficacy of drugs used in children. I was proud to have helped author
    these laws when I was a member of the Health, Education, Labor, and
    Pensions Committee. While we have made tremendous progress in advancing
    treatments for children because of these laws, there are gaps. For
    example, there is a loophole in PREA that exempts drug companies from
    pediatric study requirements when the treatment would only be used for
    a rare pediatric condition.
      There are close to 7,000 rare diseases without appropriate
    treatments, and the vast majority of these diseases affect children as
    well as adults. But in developing new drugs also known as orphan drugs
    to treat rare diseases, pharmaceutical developers focus their research
    on adult patients only since they are not required to study their
    impact on children.
      Since the majority of new drugs approved by the Food and Drug
    Administration, FDA, are orphan drugs, this means that the majority of
    newly approved drugs have not been studied for their impacts on kids.
    This leaves doctors, parents, and sick kids in the dark about the best
    possible treatments. Our bill closes this loophole to require studies
    for children so that that they, too, can benefit from new and
    innovative treatments for rare diseases.
      In addition to this change, the Innovation in Pediatric Drugs Act
    would invest in pediatric studies of older, off-patent drugs. The FDA
    incentives and requirements under BPCA and PREA work for many newer
    drugs, but unfortunately cannot help encourage studies of older drugs.
    For this reason, in 2002, Congress authorized a program which funds the
    National Institutes of Health to conduct studies of off-patent drugs
    used in children that would never be completed otherwise. Drug studies
    are expensive, and costs have only increased since then, but the
    program has been flat-funded at $25 million since it was created more
    than 20 years ago. Our legislation would increase the authorization for
    the BPCA NIH program to ensure we have better data about older drugs to
    treat diseases in children.
      Lastly, the Innovation in Pediatric Drugs Act would give FDA the
    authority it needs to ensure that legally required pediatric studies
    are completed in a timely manner. Due dates for studies required by
    PREA are typically deferred by FDA until after the approval of the drug
    for adults, but FDA has no effective enforcement tools to ensure that
    these studies are completed on time--or at all.
      I am pleased to be working with my colleague Senator Capito again on
    pediatric health issues. We have worked closely for many years on
    pediatric cancer, first authoring the Childhood Cancer Survivorship,
    Treatment, Access, and Research, STAR, Act in 2015. That bill was
    signed into law in 2018, and we worked to fully fund the law every year
    since.
      I look forward to working with her to move the Innovation in
    Pediatric Drugs Act forward, to give children and their families more
    options for treatments.
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