Since the 21st Century Cures Act passed, FDA approvals have relied on fewer studies
Since the passage of the 21st Century Cures Act in 2016, Food and Drug Administration (FDA) approvals for new medical products have relied on fewer studies, according to a study published Aug. 26, 2026, in the PLOS ONE by researchers from the Stanford University School of Medicine Clinical Excellence Research Center, Oregon State University and UCLA, U.S.
Since the implementation of the 21st Century Cures Act in 2016, the Food and Drug Administration (FDA) has been approving new medical products based on fewer studies, according to a study published on August 26, 2026, in the journal PLOS ONE. Researchers from Stanford University, Oregon State University, and UCLA analyzed 6,763 studies associated with FDA novel drug approvals between January 1, 2016, and December 21, 2024.
They found that the average number of clinical trials supporting each approval dropped from 3.41 in 2016 to 1.5 by 2022. In 2016, 59.1% of drugs received approval after three or more trials, compared to only 11.8% in 2021. By 2024, 69.4% of products were approved based on a single trial. Lead author Aditya Narayan noted that the mean number of studies per approval declined significantly.
Senior author Robert Kaplan expressed concern over the practice of approving medications on the basis of a single trial, as it allows products to reach the market without independent confirmation of the findings. The study also revealed an increase in industry-funded studies, with 44.6% of trials being industry-funded in 2016, compared to 80.4% by 2024.
The average time to publish clinical trial results exceeded a year. While the review establishes an association between the Cures Act and the decrease in studies, it cannot confirm whether this relationship is causal. The authors suggest that the Cures Act may have accelerated new drug approvals, but the reliance on single studies raises concerns about patient safety and the effectiveness of new therapeutics.
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