New “21st Century Cures” Legislation: Speed and Ease vs Science

While the final 21st Century Cures Act signed in December 2016 included welcome NIH funding increases and provisions for opioid and mental health programs, its FDA-related provisions are problematic because they encourage the agency to rely on less rigorous evidence for drug approval, including insufficiently validated biomarkers, patient experience data, and “real world evidence” from observational data rather than randomized controlled trials. They contend that these changes, combined with an antiregulatory ideology in the new Trump administration, could undermine patient safety and the drug development enterprise by prioritizing speed over science.