On June 6, 2024, Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) released a letter requesting information from stakeholders on their 21st Century Cures initiative, a policy effort focused on medical research and health care transformation and reforms. With this opportunity to comment, the lawmakers have renewed their commitment to developing the initiative with the support of the health community, nearly eight years after the passage of the 21st Century Cures Act (Pub. L. 114-255).

Enacted in December 2016, the bipartisan 21st Century Cures Act was led by Reps. DeGette and Fred Upton (R-MI) and represented a landmark legislative effort to accelerate health research and delivery reforms across the United States. The legislation aimed to expedite the discovery, development, and delivery of novel treatments and cures and provide these advancements to patients efficiently. The bill allocated substantial funding to the National Institutes of Health (NIH) to support cutting-edge biomedical research; specifically, it provided $4.8 billion over 10 years to the NIH to support the Precision Medicine Initiative, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and cancer research through the Cancer Moonshot. Additionally, the legislation streamlined regulatory processes at the Food and Drug Administration, including provisions to speed up the review of novel therapies, encourage the use of real-world evidence in approvals, and allow for adaptive trial designs. Notably, it also introduced crucial reforms in mental health care, supported advancements in health information technology, and emphasized the importance of patient perspectives in the development and regulation phases for emerging drugs.

Building on the success of this effort, Reps. DeGette and Upton introduced the Cures 2.0 Act (H.R. 6000) in 2021, which contained additional measures to address pandemic preparedness and public health issues, caregiver and patient engagement, drug development and clinical trial diversity, telehealth procedures, insurance coverage, and biomedical research. The legislation also called for the establishment of the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to award funding through grants, contracts, cash prizes, and other means to high-risk, high-reward biomedical research.

In their new letter, Reps. DeGette and Bucshon provide updates on the advancements currently in progress from the Cures 2.0 Act legislation. While the Cures 2.0 bill never became a law, certain provisions advanced in other vehicles, such as the establishment of ARPA-H and reforms to the FDA, including guidance on cell and gene therapy, expedited drug approval processes, and the integration of evidence in regulatory decision-making. The lawmakers also highlight developments in the national preparedness infrastructure and strategies to address Long COVID.

The lawmakers note these successes are “initial steps towards our broader objectives.”

Thus, stakeholders are invited to provide their insights on three core questions: (1) whether the policies included in Cures 2.0 meet the intended goals, (2) identifying any missing elements essential for further progress, and (3) suggesting additional reforms, support mechanisms, or incentives to enhance the effectiveness of current measures. Reps. DeGette and Bucshon explain stakeholder responses “are crucial,” as the lawmakers believe a collaborative approach will ensure their initiative will remain dynamic, patient-centered, and responsive to emerging challenges and opportunities. Comments to the letter are due August 2, 2024.