1 From the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge (L.G., I.G.C., H.F.L.), and Harvard Catalyst-Harvard Clinical and Translational Science Center, Harvard Medical School (L.G., I.G.C., B.E.B., H.F.L.), Boston Children's Hospital (S.K.), the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University (B.E.B.), and Brigham and Women's Hospital and Harvard Medical School (B.E.B.), Boston - all in Massachusetts; and the Perelman School of Medicine and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia (E.A.L., H.F.L.).