1. Rebecca E. Wolitz is with the Moritz College of Law, The Ohio State University, Columbus. Jonathan J. Darrow and Aaron S. Kesselheim are with the Program on Regulation, Therapeutics, and Law, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA. Jonathan J. Darrow is also with the Department of Law & Taxation, Bentley University, Waltham, MA.