1 Reed F. Beall, Ph.D., is an Assistant Professor at the Cummings School of Medicine and O'Brien Institute of Public Health, University of Calgary, Calgary, AB, Canada. He is also affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Jonathan J. Darrow, S.J.D., J.D., M.B.A., is affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Aaron S. Kesselheim, M.D., J.D., M.P.H., is affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.