The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and “bring new innovations and advances” to patients more quickly and efficiently. Yet some researchers suggest that the law is being used to bypass the once rigorous and evidence-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.
According to a research letter published on Aug. 8 in the Journal of the American Medical Association Network Open (JAMA), 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration (FDA) were based on a single study, with only four drugs having more than three studies to support their approval.
