The FDA doesn't always approve drugs and medical devices that pass their trial goals, according to a study led by researchers from New Haven, Conn.-based Yale School of Medicine and Boston's Brigham and Women's Hospital.
From 2018 through 2021, the FDA approved 1 in 10 drugs based on studies in which the drug candidates failed to meet their endpoints, the research found, according to USA Today. There were 210 new therapies approved during this time, and of those, 21 didn't achieve at least one of their study's main goals. Those approved drugs with unclear efficacy include Alzheimer's, infectious disease, psychiatric and cancer treatments.
The FDA should ensure that its "rubber stamp … — considered the gold standard around the world — really means the drug has been proven to have safety and efficacy that outweighs any risk," Reshma Ramachandran, MD, an assistant professor at Yale School of Medicine who co-authored the study, told USA Today.