The commercial speech doctrine in health regulation: The clash between the public interest in a robust first amendment and the public interest in effective protection from harm

American Journal of Law and Medicine

Volumn 37, Issue 2-3, 2011, Pages 299-314

  Orentlicher, David ^a,b  

^a UNIVERSITY OF IOWA COLLEGE OF LAW   (United States)

^b INDIANA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; ARTICLE; DATA MINING; DRUG INDUSTRY; HUMAN; JURISPRUDENCE; LEGAL ASPECT; OFF LABEL DRUG USE; UNITED STATES;

ADVERTISING AS TOPIC; DATA MINING; DRUG INDUSTRY; HUMANS; OFF-LABEL USE; SUPREME COURT DECISIONS; UNITED STATES;

EID: 80051836654     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885881103700205     Document Type: Article

References (77)

1. Jacobson v. Massachusetts, 197 U.S. 11, 28-29 (1905).
2. Abigail Alliance for Better Access to Dev. Drugs v. von Eschenbach (Abigail II), 445 F.3d 470, 486 (D.C. Cir. 2006), rev'd en banc, 495 F.3d 695 (D.C. Cir. 2007). To be sure, the en banc D.C. Circuit reversed the panel's decision fifteen months later.
3. Thompson v. W. States Med. Ctr. (Western States), 535 U.S. 357 (2002).
4. Sch. Bd. of Nassau Cnty., Fla. v. Arline, 480 U.S. 273, 288 (1987).
5. See Mark A. Hall, Mary Anne Bobinski & David Orentlicher, Health Care Law and Ethics 1296 (7th ed. 2007).
6. Jacobson v. Massachusetts, 197 U.S. 11 (1905).
7. Union Pac. Ry. Co. v. Botsford, 141 U.S. 250, 251 (1891).
8. People v. Adams, 597 N.E.2d 574, 579 (111. 1992).
9. Whalen v. Roe, 429 U.S. 589 (1977).
10. Abigail II, 445 F.3d 470, 472 (D.C. Cir. 2006).
11. rev'd en banc, 495 F.3d 695 (D.C. Cir. 2007).
12. 21 C.F.R. §§ 312.21(a)-(c) (2010).
13. 21 C.F.R. § 312.34 (2010).
14. see also Abigail II, 445 F.3d at 474 (internal citation omitted) ("Although the FDA may permit 'treatment use' of unapproved new drugs, the FDA has refused as a general matter to allow terminally ill patients to have access to investigational new drugs that have successfully completed Phase I trials.").
15. See Abigail II, 445 F.3d at 473-74.
16. Abigail Alliance for Better Access to Dev. Drugs v. von Eschenbach (Abigail III), 495 F.3d 695, 700 (D.C. Cir. 2007) (en banc).
17. Abigail II, 445 F.3d at 486.
18. Abigail III, 495 F.3d at 728.
19. Western States, 535 U.S. 357, 360 (2002).
20. Indeed, the Court established its commercial speech doctrine in a case involving state regulation of the sale of prescription drugs by pharmacies. In that case, the Court struck down a Virginia ban on advertising by pharmacies of drug prices. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 773 (1976).
21. IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010).
22. Ralph F. Hall & Elizabeth S. Sobotka, Inconsistent Government Policies: Why FDA Off- Label Regulation Cannot Survive First Amendment Review under Greater New Orleans, 62 Food & Drug L.J. 1, 6 (2007).
23. See Wash. Legal Found, v. Friedman, 13 F. Supp. 2d 51, 71-72 (D.D.C. 1998) (noting that after a drug approved for a particular use is in interstate commerce, "one of the few mechanisms available to FDA to compel manufacturer behavior is to constrain their marketing options").
24. vacated as moot sub nom. Wash. Legal Found, v. Henney, 202 F.3d 331 (D.C. Cir. 2000).
25. See Wash. Legal Found, v. Henney, 202 F.3d 331, 335-36 (D.C. Cir. 2000) ("In response to questioning at oral argument, the government definitively stated that it subscribed to the 'safe harbor' interpretation and further explained that, in its view, neither the FDAMA nor the CME Guidance independently authorizes the FDA to prohibit or to sanction speech.").
26. This would be akin to a limitation on the amount of compounding that pharmacists could undertake. See supra text accompanying note 44.
27. See Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001).
28. See 44 Liquormart v. Rhode Island, 517 U.S. 484 (1996).
29. See Bates v. State Bar of Ariz., 433 U.S. 350 (1977).
30. Western States, 535 U.S. 357 (2002).
31. See, e.g., Wash. Legal Found, v. Henney, 202 F.3d 331, 335-36 (D.C. Cir. 2000).
32. Wash. Legal Found, v. Friedman, 13 F. Supp. 2d 51, 71-72 (D.D.C. 1998).
33. (citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980)).
34. Sch. Bd. of Nassau Cnty., Fla. v. Arline, 480 U.S. 273 (1987).
35. Ann Hubbard, Understanding and Implementing the ADA's Direct Threat Defense, 95 Nw. U. L. Rev. 1279, 1297-1305 (2001).
36. Arline, 480 U.S. at 287-88.
37. Cf. Leslie E. Gerwin, Planning for Pandemic: A New Modelfor Governing Public Health Emergencies, 37 Am. J.L. & Med. 128, 132-33 (2011) (proposing an independent expert body to advise governors or other executive officials who are considering whether to invoke their emergency powers in response to threats to the public health).
38. See Jacobson v. Massachusetts, 197 U.S. 11, 25-28 (1905).
39. (quoting Mass. Rev. Laws ch. 75, § 137 (1902)).
40. See Western States, 535 U.S. 357, 374, 377 (2002).
41. see also Food and Drug Administration Modernization Act of 1997 § 127(a), 21 U.S.C. § 353a (2006).
42. See Western States at 362-63.
43. Petition for Writ of Certiorari at 71a, Western States, 535 U.S. 357 (2002) (No. 01-344) (Appendix D of the Petition).
44. Grutter v. Bollinger, 539 U.S. 306, 328 (2003).
45. David Orentlicher, Prescription Data Mining and the Protection of Patients' Interests, 38 J.L. Med. & Ethics 74, 74 (2010).
46. N.H. Rev. Stat. Ann. § 318:47-f (2010).
47. 18 Vt. Stat. Ann. § 4631(d) (2010).
48. see also Me. Rev. Stat. tit. 22, §§ 1711-E(2) to (2-A) (2010).
49. See IMS Health Inc. v. Ayotte, 550 F.3d 42, 64 (1st Cir. 2008).
50. See IMS Health Inc. v. Mills, 616 F.3d 7, 32 (1st Cir. 2010).
51. See IMS Health Inc. v. Sorrell, 630 F.3d 263, 282 (2d Cir. 2010).
52. cert, granted, 131 S. Ct. 857 (2011) (No. 10-779).
53. Order Granting Petition for Writ of Certiorari, Sorrell v. IMS Health Inc., 131 S. Ct. 857 (2011).
54. And of course, not all expression is protected. States may prohibit the publication of obscenity or speech that is likely to incite imminent violence. See generally Brandenburg v. Ohio, 395 U.S. 444, 448 (1969).
55. See IMS Health Inc. v. Ayotte, 550 F.3d 42, 52-53 (1st Cir. 2008).
56. Brief for New England Journal of Medicine et al. as Amici Curiae at 10-20, Sorrell v. IMS Health Inc., petition for cert, granted, 131 S. Ct. 857 (2011) (No. 10-779), 2011WL 771329 at *10-20.
57. Mark A. Hall, Law, Medicine, and Trust, 55 Stan. L. Rev. 463, 470-71 (2002).
58. David Orentlicher, Health Care Reform and the Patient-Physician Relationship, 5 Health Matrix 141, 147-48 (1995).
59. Eugene Volokh, Freedom of Speech and Information Privacy: The Troubling Implications of a Right to Stop People from Speaking About You, 52 Stan. L. Rev. 1049, 1057- 58 (2000).
60. Restatement (Second) of Agency § 388 cmt. c (2010).
61. See also Thomas L. Hafemeister and Sarah P. Bryan, Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing, 57 Kan. L. Rev. 491, 519-32 (2009) (discussing the physician's fiduciary duty to patients in the context of drug company marketing efforts).
62. Restatement (Second) of Agency § 388 cmt. c (2010).
63. Geoffrey C. Hazard & W. William Hodes, The Law of Lawyering: A Handbook on The Model Rules of Professional Conduct § 12.7, at 12-22 (Supp. 2004).
64. Model Rules of Prof'l Conduct R. 1.8(b) (2011).
65. N.H. Rev. Stat. Ann. § 318:47-f (2010).
66. See Mark A. Hall & Carl E. Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 Mich. L. Rev. 643, 682 (2008) (footnotes omitted) ("[D]rug companies are not fiduciaries but sell wares like any merchant. Second, drug prices are readily stated and readily disclosed before purchase, so that, unlike hospital prices, pharmaceutical prices reflect what many informed purchasers will pay in arm's length transactions.").
67. Neil M. Richards, Reconciling Data Privacy and the First Amendment, 52 UCLA L. Rev. 1149, 1173-74 (2005).
68. Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980).
69. IMS Health Inc. v. Sorrell, 630 F.3d 263, 266 (2d Cir. 2010).
70. cert, granted, 131 S. Ct. 857 (2011) (No. 10-779).
71. See, e.g., Sorrell, 630 F.3d at 275-76.
72. IMS Health v. Ayotte, 490 F. Supp. 2d 163, 178, 183 (D.N.H. 2007).
73. rev'd, 550 F.3d 42 (1st Cir. 2008).
74. See, e.g., Sorrell, 630 F.3d at 275-76.
75. Ayotte, 490 F. Supp. 2d at 180-82.
76. See, e.g., Sorrell, 630 F.3d at 279-82.
77. Ayotte, 490 F. Supp. 2d, at 181-83.