1 From the Department of Health Policy, London School of Economics and Political Science, London (O.J.W.); the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School - both in Boston (W.B.F.); and the College of Law, West Virginia University, Morgantown (S.S.T.).