Harvard Professors Take Aim At 'Cures' Registry, Biomarker Development Language

Two Harvard professors of medicine expressed concern in a New England Journal of Medicine article that proposals included in the 21st Century Cures Act could lead to “less salutary” outcomes for patients, citing provisions that would allow companies to rely on clinical experience to support a new drug indication for already approved drugs, as well as language that waives informed consent requirements for certain medical device sponsors if the proposed clinical testing poses minimal risk. “Embedded in the language...