A proliferation of new data sources and sophisticated analytic methods are helping researchers transform real-world data (RWD) into real-world evidence (RWE) to address important healthcare questions. Regulators and policymakers recognize the power of policy to realize the full potential of data to improve patient care and outcomes.
In June 2024, Representatives Diana DeGette (D-CO) and Larry Bucshon, M.D. (R-IN) requested stakeholder input on ways Congress can continue to advance the 21st Century Cures Initiative. The 21st Century Cures Act enacted in December 2016 established the RWE Program at FDA (see more below). The RWE Alliance responded to the request for information, encouraging any future Cures legislation to expand upon these prior efforts to enhance the use of RWE in biomedical research and regulatory decision making.
In September 2023, the Senate HELP Committee’s top Republican, Dr. Bill Cassidy (R-LA), released a white paper and solicited stakeholder feedback on the role of Congress in legislating and conducting oversight on the integration of artificial intelligence (AI) in health, education, and labor. A summary of the white paper can be found here.
In June 2021, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released draft follow-up legislation to the 21st Century Cures Act. The “Cures 2.0 Act” discussion draft includes several provisions related to the use of RWE in regulatory decision making, including provisions to establish a Real-World Evidence Task Force and issue guidance on the use of RWE in evaluating safety and effectiveness in various FDA approval pathways, among other policies.
PUBLIC LAW 114-255
The 21st Century Cures Act (Cures Act), enacted in December 2016, directs FDA to establish a program to evaluate the potential use of RWE to help support the approval of a new indication for an already-approved drug or satisfy drug post-approval study requirements. The Cures Act provided FDA two years to develop a draft framework to implement this program.