Last May, members of the US House of Representatives announced the 21st Century Cures initiative to keep America at the forefront of medical innovation.
The initiative has been studying medical regulation from discovery in basic science to drug and device development through to treatment delivery and identifying the resources and the potential changes needed to reduce barriers to progress. The Foundation is closely following these efforts because they are well-aligned with our mission to bring technology advances more quickly to the patients who need them. The work of 21st Century Cures could lead to new legislation that will allow the FDA, NIH, and other federal health agencies to update and improve efficiency in several ways.
The congressional committee created a White Paper summarizing their initial legislative ideas that have stemmed from discussions with various stakeholders around the country throughout the past several months. The five main sections of legislation they have initially drafted would:
(1) put patients first by incorporating their perspectives into the regulatory process and addressing their unmet medical needs;
(2) build the foundation for 21st century medicine, including helping young scientists;
(3) modernize clinical trials;
(4) support continued innovation at our federal public health agencies (FDA, NIH, CMS, CDC); and
(5) modernize medical product regulation.
Jessica Foley, PhD, the Foundation’s Chief Scientific Officer states, “It’s clear that Congress is aware that patients and the entire biomedical ecosystem will benefit from modernized and streamlined regulatory processes. They are taking steps that aim to accelerate the medical innovation pathway, bringing new therapies to patients faster, which is also our mission at the Foundation.”
Many important organizations are weighing in on this initiative. One of them, FasterCures, has filed official responses that closely parallel our support of the project, particularly with respect to the importance of including patient perspectives and maximizing the capabilities of the FDA and the NIH. The FasterCures responses are available on their website here and here.