From the Regulatory Science Program and James E. Rogers College of Law, University of Arizona, Tucson (C.R.); New York University School of Law, New York (C.R.); and 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 (A.S.K.).