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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

Published online by Cambridge University Press:  06 January 2021

David Orentlicher
David Orentlicher*
Affiliation:
University of Iowa College of Law, Hall Center for Law and Health, Indiana University School of Law-Indianapolis
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Extract

Historically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. Thus, for example, when considering a constitutional challenge to mandatory smallpox immunization in Jacobson v. Massachusetts, the Supreme Court employed its highly deferential, rational basis review rather than the stricter level of scrutiny that it normally employs when individuals assert interests in bodily integrity. Similarly, Congress and the Food and Drug Administration (FDA) have imposed greater restrictions on the speech of pharmaceutical companies than have been considered acceptable for speech in other commercial settings.

In recent years, however, it appears that a trend is developing toward applying the same level of constitutional scrutiny to health regulation. In Abigail Alliance, a three-judge panel in the U.S. Court of Appeals for the D.C. Circuit overrode FDA regulations to recognize a constitutional right of access for patients to experimental chemotherapy.

Type
Article
Information
American Journal of Law & Medicine , Volume 37 , Issue 2-3 , June 2011 , pp. 299 - 314
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2011

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References

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 See id. at 1171, 1296.

7 Jacobson v. Massachusetts, 197 U.S. 11 (1905).

8 Id. at 22.

9 Id. at 24.

10 Id. at 27.

11 Id. at 28.

12 Id. at 31.

13 Id. at 26, 29.

14 See id. at 26 (“There are manifold restraints to which every person is necessarily subject for the common good . . . . This court has more than once recognized . . . that ‘persons’ . . . are subjected to all kinds of restraints and burdens in order to secure the general comfort, health, and prosperity of the state . . . .”).

15 Union Pac. Ry. Co. v. Botsford, 141 U.S. 250, 251 (1891).

16 People v. Adams, 597 N.E.2d 574, 579 (Ill. 1992).

17 Id. at 586.

18 Id. at 577.

19 Whalen v. Roe, 429 U.S. 589 (1977).

20 Id. at 591.

21 Id. at 597.

22 Abigail II, 445 F.3d 470, 472 (D.C. Cir. 2006), rev’d en banc, 495 F.3d 695 (D.C. Cir. 2007).

23 21 C.F.R. §§ 312.21(a)-(c) (2010); see also Abigail II, 445 F.3d at 473 (“The FDA has promulgated regulations that require three phases of government testing on humans before investigational new drugs can receive FDA approval.”).

24 21 C.F.R. § 312.34 (2010); 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.”).

25 See Abigail II, 445 F.3d at 473-74.

26 Id. at 471.

27 Id.

28 Abigail Alliance for Better Access to Dev. Drugs v. von Eschenbach (Abigail III), 495 F.3d 695, 700 (D.C. Cir. 2007) (en banc).

29 Id.

30 Id.

31 Abigail II, 445 F.3d at 486.

32 Id.

33 Abigail III, 495 F.3d at 728.

34 Western States, 535 U.S. 357, 360 (2002).

35 See id. at 360-63.

36 Id. at 360.

37 Id. at 361.

38 Id. at 377.

39 See supra note 24 and accompanying text.

40 Western States, 535 U.S. at 362.

41 Id. at 362-64.

42 Id. at 364-65.

43 Id. at 372.

44 Id.

45 Id. at 367-68.

46 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).

47 IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010), cert. granted, 131 S. Ct. 857 (2011) (No. 10-779).

48 Hall, Ralph F. & Sobotka, Elizabeth S., 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).Google ScholarPubMed

49 Id. at 4-5.

50 Id. at 4.

51 Id.

52 Id. at 6.

53 Id.

54 Id. at 6-8.

55 Id. at 5-6.

56 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”), vacated as moot sub nom. Wash. Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000).

57 Id. at 56-57.

58 Id.

59 See, e.g., id. at 72.

60 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.”).

61 Id. at 335-36.

62 Id. at 336.

63 This would be akin to a limitation on the amount of compounding that pharmacists could undertake. See supra text accompanying note 44.

64 See Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001).

65 See 44 Liquormart v. Rhode Island, 517 U.S. 484 (1996).

66 See Bates v. State Bar of Ariz., 433 U.S. 350 (1977).

67 Western States, 535 U.S. 357 (2002).

68 See, e.g., Wash. Legal Found. v. Henney, 202 F.3d 331, 335-36 (D.C. Cir. 2000); Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 71-72 (D.D.C. 1998); see also Hall & Sobotka, supra note 48, at 13.

69 Western States, 535 U.S. at 367 (citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 66 (1980)).

70 Id.

71 Sch. Bd. of Nassau Cnty., Fla. v. Arline, 480 U.S. 273 (1987).

72 Id. at 276.

73 Id.

74 Id. at 287 n.16. Since the case was decided under the Rehabilitation Act, its holding applies to private recipients of federal funding. And since the case’s reasoning was incorporated into the Americans with Disabilities Act, it applies as well to all private operators of public accommodations. Hubbard, Ann, Understanding and Implementing the ADA’s Direct Threat Defense, 95 Nw. U. L. Rev. 1279, 1297-1305 (2001).Google Scholar

75 Arline, 480 U.S. at 287-88.

76 Cf. Gerwin, Leslie E., Planning for Pandemic: A New Model for Governing Public Health Emergencies, 37 Am. J.L. & Med. 128, 132-33 (2011)Google ScholarPubMed (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).

77 See Jacobson v. Massachusetts, 197 U.S. 11, 25-28 (1905).

78 Id. at 27 (quoting Mass. Rev. Laws ch. 75, § 137 (1902)).

79 See id.

80 See Western States, 535 U.S. 357, 374, 377 (2002).

81 Id. at 360; see also Food and Drug Administration Modernization Act of 1997 § 127(a), 21 U.S.C. § 353a (2006).

82 See Western States at 362-63.

83 Petition for Writ of Certiorari at 71a, Western States, 535 U.S. 357 (2002) (No. 01-344) (Appendix D of the Petition).

84 Grutter v. Bollinger, 539 U.S. 306, 328 (2003).

85 Orentlicher, David, Prescription Data Mining and the Protection of Patients’ Interests, 38 J.L. Med. & Ethics 74, 74 (2010).CrossRefGoogle ScholarPubMed

86 See id. at 74-75.

87 See id. at 75.

88 Id.

89 Id.

90 See id. at 75-76.

91 See id. at 75.

92 N.H. Rev. Stat. Ann. § 318:47-f (2010).

93 18 Vt. Stat. Ann. § 4631(d) (2010).

94 Orentlicher, supra note 85, at 78; see also Me. Rev. Stat. tit. 22, §§ 1711-E(2) to (2-A) (2010).

95 See IMS Health Inc. v. Ayotte, 550 F.3d 42, 64 (1st Cir. 2008).

96 See IMS Health Inc. v. Mills, 616 F.3d 7, 32 (1st Cir. 2010).

97 See IMS Health Inc. v. Sorrell, 630 F.3d 263, 282 (2d Cir. 2010), cert. granted, 131 S. Ct. 857 (2011) (No. 10-779).

98 Order Granting Petition for Writ of Certiorari, Sorrell v. IMS Health Inc., 131 S. Ct. 857 (2011).

99 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).

100 See Orentlicher, supra note 85, at 80.

101 See id.

102 See IMS Health Inc. v. Ayotte, 550 F.3d 42, 52-53 (1st Cir. 2008).

103 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), 2011 WL 771329 at *10-20.

104 Id. at *14, *18-20, *32-33.

105 See Orentlicher, supra note 85, at 75-76.

106 Hall, Mark A., Law, Medicine, and Trust, 55 Stan. L. Rev. 463, 470-71 (2002).CrossRefGoogle ScholarPubMed

107 Orentlicher, David, Health Care Reform and the Patient-Physician Relationship, 5 Health Matrix 141, 147-48 (1995).Google ScholarPubMed

108 Id.

109 Id.

110 Id.

111 And in fact, federal law prohibits most such “self-referrals” by physicians. Hall, Bobinski & Orentlicher, supra note 5, at 1372-73.

112 Volokh, Eugene, 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).CrossRefGoogle Scholar

113 Restatement (Second) of Agency § 388 cmt. c (2010). See also Hafemeister, Thomas L. and Bryan, Sarah P., Beware Those Bearing Gifts: Physicians’ Fiduciary Duty to Avoid Pharmaceutical Marketing, 57 Kan. L. Rev. 491, 519-32 (2009)Google Scholar (discussing the physician’s fiduciary duty to patients in the context of drug company marketing efforts).

114 Restatement (Second) of Agency § 388 cmt. c (2010); 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).

115 Model Rules of Prof’l Conduct R. 1.8(b) (2011).

116 N.H. Rev. Stat. Ann. § 318:47-f (2010).

117 See Hall, Mark A. & Schneider, Carl E., Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 Mich. L. Rev. 643, 682 (2008)Google ScholarPubMed (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.”).

118 See Orentlicher, supra note 85, at 76-77.

119 I am grateful to Professor Kevin Outterson for this point. See also Hall, Bobinski & Orentlicher, supra note 5, at 1373.

120 Richards, Neil M., Reconciling Data Privacy and the First Amendment, 52 UCLA L. Rev. 1149, 1173-74 (2005).Google Scholar

121 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 566 (1980).

122 See, e.g., id. at 568; IMS Health Inc. v. Sorrell, 630 F.3d 263, 266 (2d Cir. 2010), cert. granted, 131 S. Ct. 857 (2011) (No. 10-779).

123 See, e.g., Sorrell, 630 F.3d at 275-76; IMS Health v. Ayotte, 490 F. Supp. 2d 163, 178, 183 (D.N.H. 2007), rev’d, 550 F.3d 42 (1st Cir. 2008).

124 See, e.g., Sorrell, 630 F.3d at 275-76; Ayotte, 490 F. Supp. 2d at 180-82.

125 See, e.g., Sorrell, 630 F.3d at 279-82; Ayotte, 490 F. Supp. 2d, at 181-83.