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You Can't Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban

Published online by Cambridge University Press:  06 January 2021

Lia Mulligan
Lia Mulligan*
Affiliation:
Boston University School of Law, Hofstra University
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Extract

In one year, you will watch roughly sixteen hours of pharmaceutical advertisements. Sometime during those sixteen hours, you may recognize in yourself the symptoms portrayed in the advertisements. You may even wonder whether you would benefit from a particular drug. But will you visit your doctor with the fear that you may be suffering from a previously undiagnosed disease? Will you encourage your doctor to prescribe the medication you saw in the advertisements? Will your insurance cover the costs of your medication? More importantly, will you even need the medication at all?

The trend in the pharmaceutical industry to increase yearly spending on direct-to-consumer pharmaceutical advertising (DTCA) seems almost disrespectful considering the magnitude of the healthcare crisis in which the United States is currently embroiled. This notion is inflamed when accounting for the fact that (arguably) one of the biggest problems in our healthcare system is the amount of money spent on healthcare each year.

Type
Article
Information
American Journal of Law & Medicine , Volume 37 , Issue 2-3 , June 2011 , pp. 444 - 467
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2011

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References

1 See Frosch, Dominick L. et al., Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising, 5 Annals Fam. Med. 6, 6 (2007).CrossRefGoogle ScholarPubMed

2 The pharmaceutical industry as a whole spent $4.7 billion on DTCA in 2008, up from $4.2 billion in 2005. Cong. Budget Office, Promotional Spending for Prescription Drugs 2 (2009), available at http://cbo.gov/ftpdocs/105xx/doc10522/12-02-DrugPromo_Brief.pdf [hereinafter CBO Report]; Shuchman, Miriam, Drug Risks and Free Speech—Can Congress Ban Consumer Drug Ads?, 356 New Eng. J. Med. 2236, 2237 (2007).CrossRefGoogle ScholarPubMed

3 130 S. Ct. 876 (2010).

4 Humphreys, Gary, Direct-to-Consumer Advertising Under Fire, 87 Bull. World Health Org. 576, 576 (2009)Google Scholar (Switz.), available at http://www.who.int/bulletin/volumes/87/8/09-040809/en/index.html.

5 Susan Thaul, Cong. Research Serv., R40590, Direct-to-Consumer Advertising of Prescription Drugs 8-14 (2009), available at http://opencrs.com/document/R40590 [hereinafter CRS Report].

6 Id. at 9.

7 Pub. L. No. 75-717, 52 Stat. 1040 (1938).

8 CRS Report, supra note 5, at 8-9.

9 Kefauver-Harris Amendment, Pub. L. No. 87-781, 76 Stat. 780 (1962); CRS Report, supra note 5, at 8-9.

10 CRS Report, supra note 5, at 9.

11 Id.

12 Rosenthal, Meredith B. et al., Promotion of Prescription Drugs to Consumers, 346 New Eng. J. Med. 498, 500 fig.1 (2002).CrossRefGoogle Scholar

13 See CRS Report, supra note 5, at 10. Following this FDA guidance, overall spending on DTCA increased dramatically, from about $1 billion in 1997 to approximately $2.5 billion in 2000, and eventually to over $4.7 billion in 2007. Id. at 7 tbl.1; Rosenthal et al., supra note 12, at 500 tbl.1.

14 FDA, U.S. Dep’t of Health & Human Servs., Guidance for Industry: Consumer-Directed Broadcast Advertisements, Draft Guidance 1-3 (1999), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070065.pdf. The four options listed to fulfill this requirement were: listing a toll-free telephone number, a website, a publication carrying the print advertisement, or to suggest that viewers talk to their doctor about the advertised product. Id. at 2-3.

15 FDA, U.S. Dep’t of Health & Human Servs., Guidance for Industry Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements, Draft Guidance (2004), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm069984.pdf.

16 See id. at 2.

17 Id.

18 Id. at 5-6. Pharmaceutical companies were given three options by which to satisfy these requirements: they could (1) print the product’s entire approved patient label; (2) print only the product’s risk information as it is written on the approved patient label; or (3) rewrite the risk information from the product’s approved physician label in a way that consumers would be able to comprehend. Id. at 3-6.

19 Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110–85, 121 Stat. 823 [hereinafter FDAAA] (codified as amended in scattered sections of 21 U.S.C.).

20 See id. § 901(d)(2), 121 Stat. 823, 939-40. Though drug companies are not required to submit their ads for pre-market review or approval, they must submit their advertisements upon their publication in print or through broadcast media. Despite the authority to require pre-market review, the Secretary was not given the authority to direct or require changes to advertisements, except where the advertisements would otherwise be false or misleading about safety or risk information. Id.

21 Id. § 104, 121 Stat. 823, 832.

22 Id.

23 Id. § 901(d)(4), 121 Stat. 823, 941; see also CRS Report, supra note 5, at 14.

24 FDAAA § 104, 121 Stat. 823, 838-39.

25 CRS Report, supra note 5, at 13.

26 See FDAAA § 901(d)(4), 121 Stat. 940-41. All dissemination of the same or similar violative advertisement prior to notification of violation is considered to be one violation. Every day that a violative advertisement is released to the public, through any media, counts as one violation, regardless of how many times that advertisement is released throughout that day. Id.

27 Id. § 104, 121 Stat. 823, 942.

28 Id.

29 See CRS Report, supra note 5, at 18. The FDA also has approximately fifty staff members assigned to monitor the side effects of approved drugs and disseminate information of newly approved drugs to the public. Id.

30 Prescription Drugs: Trends in FDA’s Oversight of Direct-to-Consumer Advertising: Hearing Before Subcomm. on Oversight and Investigations, Comm. on Energy and Commerce, H.R., 110th Cong. 7 (2008) (statement of Marcia Crosse, Director, Health Care). In 2007, the FDA received an estimated 21,000 DTC advertisements upon their publication (as required by law), and the number appears to be steadily increasing each year. Id.

31 In 2008, Pharmaceutical Researchers and Manufacturers of America (PhRMA) members were estimated to have made approximately $189 billion in domestic sales of pharmaceuticals and medicines. CBO Report, supra note 2, at 2. That same year, pharmaceutical companies spent an estimated total of $20.5 billion on all pharmaceutical advertising, with an estimated $4.7 billion spent on DTCA alone. Id.

32 The FDA issues several warning letters to pharmaceutical companies each month whose advertisements have already spread throughout the media and are deemed misleading or untruthful. See FDA, Warning Letters, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm (last visited Mar. 17, 2011).

33 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc. (Virginia Pharmacy Bd.), 425 U.S. 748 (1976). Justice Stevens abstained. Id. at 773.

34 “What is at issue is whether a State may completely suppress the dissemination of concededly truthful information about entirely lawful activity, fearful of that information’s effect upon its disseminators and its recipients. Reserving other questions, we conclude that the answer to this one is in the negative.” Id.

35 Id.

36 See id. at 771.

37 Id.

38 Id. at 771 n.24.

39 Id. What if pharmaceutical companies were required to include retail price information on the “average” prescription in all of their advertisements? This question will not be answered here, but it is interesting nonetheless.

40 Id. at 772 (emphasis added). This further implies that the doctrine of prior restraint is not applicable in commercial speech cases, and therefore will not be analyzed in this paper.

41 Va. Pharmacy Bd., 425 U.S. at 781 (Rehnquist, C.J., dissenting).

42 Id. at 788.

43 Id. at 790.

44 447 U.S. 557 (1980).

45 Id. at 566.

46 Id. at 561-62.

47 See id. at 562.

48 Id.

49 “The Constitution therefore accords a lesser protection to commercial speech than to other constitutionally guaranteed expression. The protection available for particular commercial expression turns on the nature both of the expression and of the governmental interests served by its regulation.” Id. at 562-63 (citing Ohralik v. Ohio State Bar Ass’n, 436 U.S. 447, 456-57 (1978)).

50 Id. at 563 (emphasis added) (citing Friedman v. Rogers, 440 U.S. 1, 13, 15-16 (1979); Ohralik, 436 U.S. at 464-65).

51 See id.; Virginia Pharmacy Bd., 425 U.S. 748 (1976).

52 See Central Hudson, 447 U.S. at 561.

53 Id. at 566 n.9.

54 Id.

55 See id. at 583–606.

56 Id. at 584.

57 See Ashcroft v. ACLU, 542 U.S. 656 (2004) (statutes that restrict the fundamental right to free speech must pass strict scrutiny review); Hunt v. Cromartie, 526 U.S. 541 (1999) (instances of racial gerrymandering must be evaluated under strict scrutiny); Adarand Constructors, Inc. v. Pena, 515 U.S. 200, 235 (1995) (all racial classifications imposed by the government must pass strict scrutiny review, i.e., they “must serve a compelling governmental interest, and must be narrowly tailored to further that interest”); Roe v. Wade, 410 U.S. 113 (1973) (statutes that infringe on the right to privacy must pass strict scrutiny review).

58 517 U.S. 484 (1996).

59 Id. at 501.

60 Id.

61 Id. at 502.

62 Id. at 504.

63 Id. at 505.

64 Id. at 507. This alternative (price regulation) would not be available in the context of a DTCA ban because the prices of pharmaceuticals are not set or regulated by the government.

65 Kathleen M. Sullivan, Cheap Spirits, Cigarettes, and Free Speech: The Implications of 44 Liquormart, 1996 Sup. Ct. Rev. 123.

66 Id. at 148 (citation omitted).

67 521 U.S. 457 (1997).

68 Id. at 477.

69 Id. at 476.

70 Recall Chief Justice Rehnquist’s insistence that the regulation at issue in Central Hudson was economic in nature, thus requiring a greater level of deference to Congress. See supra text accompanying note 56.

71 527 U.S. 173 (1999).

72 Id. at 184.

73 Id. at 195; id. at 196 (Rehnquist, C.J., concurring); id. at 197 (Thomas, J., concurring).

74 Id. at 185-89 (majority opinion). The Court ended the Central Hudson inquiry at that point, and ultimately struck down the statute because of other structural flaws. Id. at 190.

75 533 U.S. 525 (2001).

76 Id. at 554-55.

77 Id. at 555.

78 Id. (quoting Fla. Bar v. Went For It, Inc., 515 U.S. 618, 628 (1995)).

79 Id. at 561, 567.

80 Opinion Announced at 7:43, Lorillard Tobacco v. Reilly, 5334.5.525 (No. 00-596), available at http://www.oyez.org/cases/2000-2009/2000/2000_00_596/opinion (last accessed Apr. 3, 2011).

81 535 U.S. 357 (2002).

82 Id. at 366 (alteration in original) (quoting Va. Pharmacy Bd., 425 U.S. at 765).

83 Id. at 367 (citing Edenfield v. Fane, 507 U.S. 761, 767 (1993)).

84 See Va. Pharmacy Bd., 425 U.S. at 771 n.24.

85 See W. States, 535 U.S. at 368.

86 Id. at 371.

87 Id. at 371-73.

88 Id. at 358.

89 Under this standard, the state must show that the statute at issue is “substantially related” to important governmental objectives. See Kimel v. Fla. Bd. of Regents, 528 U.S. 62 (2000); Miss. Univ. for Women v. Hogan, 458 U.S. 718 (1982); Craig v. Boren, 429 U.S. 190 (1976).

90 See cases cited supra note 57.

91 See W. States, 535 U.S. at 367.

92 Id. at 374.

93 Id. at 366 (emphasis added) (citing W. States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001)).

94 Id. at 378-79 (Breyer, J., dissenting). Chief Justice Rehnquist and Justices Ginsburg and Stevens joined in the dissent. Id. at 378.

95 See id. at 380.

96 Id. at 382.

97 Id.

98 Id. at 383 (emphasis added) (citing Nat’l Inst. for Health Care Mgmt., Factors Affecting the Growth of Prescription Drug Expenditures iii (1999); Francesca Lunzer Kritz, Ask Your Doctor About . . . Which of the Many Advertised Allergy Drugs Are Right for You?, Wash. Post, June 6, 2000, at 9).

99 Id. (citing Year Two: A National Survey of Consumer Reactions to Direct-to-Consumer Advertising of Prescription Drugs, Prevention Mag., no. 10, 1999 at 32; Henry J. Kaiser Family Found., Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising 3 (2001)).

100 See id. Though this reasoning is fitting for a discussion about the dangers of off-label marketing specifically, it certainly informs the discussion of DTCA as a whole since arguably some DTCA contains off-label promotion.

101 See id. at 384 (citing Rosenthal et al., supra note 12).

102 Id. at 384-85 (emphasis added).

103 Id. at 387.

104 Id. at 388-89.

105 See discussion infra Part IV.C.

106 Id.

107 See Paul, David P. et al., Primary Care Physicians’ Attitudes Toward Direct-to-Consumer Advertising of Prescription Drugs: Still Crazy After All These Years, 19 J. Consumer Marketing 564, 570 (2002)CrossRefGoogle Scholar (U.K.).

108 IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2007).

109 See id. at 45-46.

110 Id. at 51.

111 Id. at 55.

112 Id. at 44-45.

113 IMS Health Inc. v. Sorrell, 631 F. Supp. 2d 434 (D. Vt. 2009) (quoting Ayotte, 550 F.3d at 55). This decision was reversed by the Second Circuit, and is currently on cert to the United States Supreme Court. IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010), cert. granted, 131 S. Ct. 857 (U.S. Jan. 7, 2011) (No. 10-779).

114 Sorrell, 631 F. Supp. 2d at 449-50 (footnote and citation omitted).

115 IMS Health v. Mills, 616 F.3d 7 (1st Cir. 2010).

116 See id. at 13.

117 Id. at 22.

118 See supra text accompanying note 56.

119 See W. States, 535 U.S. at 382-84 (Breyer, J., dissenting).

120 Paul et al., supra note 107. The study surveyed 125 internal medicine, family, or general practice physicians from across the United States who saw an average of 354 patients each month. Id. at 569.

121 Id. at 570.

122 Id.

123 Id. at 571.

124 Park, Jin S. & Grow, Jean M., The Social Reality of Depression: DTC Advertising of Antidepressants and Perceptions of the Prevalence and Lifetime Risk of Depression, 79 J. Bus. Ethics 379, 379 (2008).CrossRefGoogle Scholar

125 See id.; see also Frosch et al., supra note 1, at 6; Alix Timko, C. & Chowansky, Amy, Direct-to-Consumer Advertising of Psychotropic Medication and Prescription Authority for Psychologists, 39 Prof. Psychol.: Research & Practice 512, 512 (2008).CrossRefGoogle Scholar

126 See Park & Grow, supra note 124, at 380 (citing Carl Elliott, Better Than Well: American Medicine Meets the American Dream (2003)); see also Timko & Chowansky, supra note 125, at 516 (citing Moynihan, Ray et al., Selling Sickness: The Pharmaceutical Industry and Disease Mongering, 324 Brit. Med. J. 886, 886 (2002)CrossRefGoogle ScholarPubMed).

127 Park & Grow, supra note 124.

128 Id. at 385-86.

129 Id. at 386.

130 See Frosch et al., supra note 1, at 6.

131 Id. at 9 tbl.2.

132 Id. at 10.

133 See Davis, Joel, The Effect of Qualifying Language on Perceptions of Drug Appeal, Drug Experience, and Estimates of Side-Effect Incidence in DTC Advertising, 12 J. Health Comm. 607, 607 (2007)CrossRefGoogle ScholarPubMed (U.K.).

134 Id. at 610.

135 See id. at 618-19.

136 See Park & Grow, supra note 124, at 388-89.

137 See supra Part II.

138 Va. Pharmacy Bd., 425 U.S. at 772.

139 Id. at 771.

140 130 S. Ct. 876 (2010).

141 Id. at 891.

142 Id. at 917.

143 Id. at 898.

144 See id. Chief Justice Roberts and Justices Alito, Kennedy, Scalia, and Thomas expressed opinions that reflected this idea; Justices Stevens, Ginsburg, Breyer, and Sotomayor dissented from this idea. Justice Kagan (then Solicitor General for the Department of Justice) represented the Federal Election Commission in this case, and later replaced Justice Breyer on the bench.

145 See id. at 917 (Roberts, C.J. & Alito, J., concurring).