[i] Marc-André Gagnon & Joel Lexchin, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United State, 5 PLOS Med 29, 29–32 (2008).
[iv] Julie M. Donohue, Marisa Cevasco, & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs, 357-7 New Eng. J. Med. 673, 675–76 (2007).
[vi] See Douglas Baird, Robert Gertner, & Randal Picker, Game Theory and the Law 188–217 (1998); Brian Skyrms, The Stag Hunt and the Evolution of Social Structure 1–4 (2003).
[vii] Concerning regulations on commercial speech about pharmaceutical products (off-label marketing): Washington Legal Found. v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998); Washington Legal Found. v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999); Washington Legal Found. v. Henney, 202 F.3d. 331 (D.C.Cir. 2000); Concerning regulations on commercial speech about pharmaceutical products: Pearson v. Shalala, 164 F.3d. 650 (D.C.Cir. 1999).
[viii] Personal communication with FDA officials in Office of Commissioner, CDER and experts in FDA law.
[ix] See Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food and Drug Law: Cases and Materials 98 (3d ed. 2007).
[xii] While the USPTO grants original patents that make up part of the bundle of IP rights, the FDA would be more suitable regulator of drug marketing, because its statutory authority and expertise in the area.
[xvi] See Krista Hessler Carver, A Global View of the First Amendment Constraints on FDA, 63 Food & Drug L. J. 151, 151–52, 156–57 (2008).
[xvii] Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557 (1980). Center Hudson Doctrine, a four part standard on government’s limitations of commercial speech: 1. Is the speech protected? That is it must be lawful, and not be fraudulent or misleading? 2. Does the government assert a "substantial" interest? 3. Does the regulation "directly" advance the government interest asserted? 4. Is the regulation the least intrusive way of advancing the government's asserted interest?
[xviii] See Henney, 56 F. Supp. 2d at 87.