The 21st Century Cures Act—Will It Take Us Back in Time?

While the 21st Century Cures Act includes welcome NIH funding increases, key provisions could weaken FDA approval standards by encouraging reliance on less rigorous evidence such as observational data, surrogate endpoints, and adaptive trial designs. The authors argue that the current drug approval process is already efficient and that lowering evidence thresholds risks approving drugs that are ineffective or harmful.