1. Almashat S, Wolfe SM, Carome M. Twenty-five years of pharmaceutical industry criminal and civil penalties: 1991 through 2015. Public Citiz. 2016. https://www.citizen.org/documents/2311.pdf . Accessed 24 Mar 2017.
2. U.S. Government Accountability Office. FDA’s oversight of the promotion of drugs for off-label uses, GAO-08-835. 2008.
3. Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51, 55 (D.D.C. 1998), amended, 36 F. Supp. 2d 16 (D.D.C. 1999), appeal dismissed, judgment vacated in part sub nom. Washington Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000), and amended, 36 F. Supp. 2d 418 (D.D.C. 1999), and appeal dismissed, judgment vacated in part sub nom. Washington Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000).
4. 21 U.S.C.A. § 331(a).
5. Thompson v. W. States Med. Ctr. 535 U.S. 357 (2002).