You can't say that on television: Constitutional analysis of a direct-to-consumer pharmaceutical advertising ban

American Journal of Law and Medicine

Volumn 37, Issue 2-3, 2011, Pages 444-467

  Mulligan, Lia ^a  

^a BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; ARTICLE; DRUG INDUSTRY; HUMAN; LEGAL ASPECT; TELEVISION; UNITED STATES;

ADVERTISING AS TOPIC; DRUG INDUSTRY; HUMANS; TELEVISION; UNITED STATES;

EID: 80051853777     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885881103700210     Document Type: Article

References (57)

1. See Dominick L. Frosch et al., Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising, 5 Annals Fam. Med. 6, 6 (2007).
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/ l05xx/docl0522/12-02-5rugPromo-Brief.pdf [hereinafter CBO Report].
3. Miriam Shuchman, Drug Risks and Free Speech-Can Congress Ban Consumer Drug Ads?, 356 New Eng. J. Med. 2236, 2237 (2007).
4. 130 S. Ct. 876 (2010).
5. Gary Humphreys, Direct-to-Consumer Advertising Under Fire, 87 Bull. World Health Org. 576, 576 (2009) (Switz.), available at http://www.who.int/bulletin/ volumes/87/8/09-040809/en/index.html.
6. Susan Thaul, Cong. Research Serv., R40590, Direct-to-Consumer Advertising of Prescription Drugs 8-14 (2009), available at http://openers.com/document/ R40590 [hereinafter CRS Report].
7. Pub. L. No. 75-717, 52 Stat. 1040 (1938).
8. Kefauver-Harris Amendment, Pub. L. No. 87-781, 76 Stat. 780 (1962).
9. Meredith B. Rosenthal et al., Promotion of Prescription Drugs to Consumers, 346 New Eng. J. Med. 498, 500 fig.l (2002).
10. FDA, U.S. Dep't of Health & Human Servs., Guidance for Industry: Consumer-Directed Broadcast Advertisements, Draft Guidance 1-3 (1999), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070065.pdf.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.
11. 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.
12. 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.).
13. 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).
14. 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).
15. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc. ( Virginia Pharmacy Bd.), 425 U.S. 748 (1976). Justice Stevens abstained.
16. Va. Pharmacy Bd., 425 U.S. at 781 (Rehnquist, C.J., dissenting).
17. "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)).
18. Id. at 563 (emphasis added) (citing Friedman v. Rogers, 440 U.S. 1, 13, 15-16 (1979); Ohralik, 436 U.S. at 464-65).
19. Virginia Pharmacy Bd., 425 U.S. 748 (1976).
20. See Central Hudson, 447 U.S. at 561.
21. See Ashcroft v. ACLU, 542 U.S. 656 (2004) (statutes that restrict the fundamental right to free speech must pass strict scrutiny review).
22. Hunt v. Cromartie, 526 U.S. 541 (1999) (instances of racial gerrymandering must be evaluated under strict scrutiny).
23. 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").
24. Roe v. Wade, 410 U.S. 113 (1973) (statutes that infringe on the right to privacy must pass strict scrutiny review).
25. Kathleen M. Sullivan, Cheap Spirits, Cigarettes, and Free Speech: The Implications of 44 Liquormart, 1996 Sup. Ct. Rev. 123.
26. 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.
27. 71527 U.S. 173 (1999).
28. 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.
29. 533 U.S. 525 (2001).
30. Id. (quoting Fla. Bar v. Went For It, Inc., 515 U.S. 618, 628 (1995)).
31. 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).
32. 535 U.S. 357(2002).
33. Id. at 366 (alteration in original) (quoting Va. Pharmacy Bd., 425 U.S. at 765).
34. Id. at 367 (citing Edenfield v. Fane, 507 U.S. 761, 767 (1993)).
35. See Va. Pharmacy Bd., 425 U.S. at 771 n.24.
36. See W. States, 535 U.S. at 368.
37. Under this standard, the state must show that the statute at issue is "substantially related" to important governmental objectives. See Kimel v. Fia. Bd. of Regents, 528 U.S. 62 (2000).
38. Miss. Univ. for Women v. Hogan, 458 U.S. 718 (1982).
39. Craig v. Boren, 429 U.S. 190 (1976).
40. Id. at 366 (emphasis added) (citing W. States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001)).
41. Id. at 378-79 (Breyer, J., dissenting). Chief Justice Rehnquist and Justices Ginsburg and Stevens joined in the dissent.
42. Id. at 383 (emphasis added) (citing Nat'l Inst, for Health Care Mgmt., Factors Affecting the Growth of Prescription Drug Expenditures iii (1999).
43. 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).
44. 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.
45. Henry J. Kaiser Family Found., Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising 3 (2001)).
46. See David P. Paul 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) (U.K.).
47. IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2007).
48. 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.
49. IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010), .
50. Cert. granted, 131 S. Ct. 857 (U.S. Jan. 7, 2011) (No. 10-779).
51. Sorrell, 631 F. Supp. 2d at 449-50 (footnote and citation omitted).
52. IMS Health v. Mills, 616 F.3d 7 (1st Cir. 2010).
53. Jin S. Park & Jean M. Grow, 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).
54. C. Alix Timko & Amy Chowansky, Direct-to-Consumer Advertising of Psychotropic Medication and Prescription Authority for Psychologists, 39 Prof. Psychol.: Research & Practice 512, 512 (2008).
55. citing Ray Moynihan et al., Selling Sickness: The Pharmaceutical Industry and Disease Mongering, 324 Brit. Med. J. 886, 886 (2002).
56. See Joel Davis, 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) (U.K.).
57. Va. Pharmacy Bd., 425 U.S. at 772.