1 Michael S. Sinha, M.D., J.D., M.P.H., is with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmaco-economics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate Professor of Medicine at Harvard Medical School and Director of the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital and a faculty member at the Harvard Center for Bioethics in Boston. He is also a faculty member at the Harvard Center for Bioethics.