Bipartisan Real-World Evidence Legislation Introduced

Three U.S. senators have introduced S.1508 (text not yet available) to “harness real-world evidence (RWE) gathered during emergency use authorization to support future approvals for drugs, biologics, and medical devices at FDA.” The bill is sponsored by Sens. Roger Marshall (R-KS), Tina Smith (D-MN), and Bill Cassidy (R-LA).

A statement issued by Marshall on behalf of all three sponsors says the legislation would enable FDA to develop a clear framework for how it uses RWE in premarket approvals ranging from drugs and vaccines to medical devices.

“Not only will this help with clinical decision-making and making practice adjustments during a pandemic,” the three say, “this legislation could also help in shortening the length of time it takes for FDA to approve a product and could help in reducing the cost for medical innovators to bring a product to market.”