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Direct-to-Consumer Prescription Drug Advertising

Published online by Cambridge University Press:  24 February 2021

Tamar V. Terzian
Tamar V. Terzian*
Affiliation:
Cornell University, Boston University School of Law
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Extract

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 25 , Issue 1 , 1999 , pp. 149 - 167
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1999

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References

1 See Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (codified in scattered sections of 21 U.S.C.).

2 See 21 U.S.C. §§ 301-392 (1994).

3 21 C.F.R. § 202.1(e)(1) (1997).

4 See 21 U.S.C. § 352(a) (1994).

5 See Mark E. Boulding, Public Comment Can Shape FDA Guidance on TV Advertising, 7 Legal Opinion Letter, Sept. 12,1997.

6 Direct-to-consumer (DTC) advertising targets its advertising directly to the ultimate consumer, in this case, the patient. See Draft Guidance for the Industry, Consumer-Directed Broadcast Advertisements; Availability, 62 Fed. Reg. 43,171, 43,172 (1997).

7 See Boulding, supra note 5.

8 See id.

9 DTC, though practiced by the prescription drug industry since the early 1980s, became increasingly popular in the 1990s. See 62 Fed. Reg. at 43,172. The Food and Drug Administration (FDA) loosened its regulatory grip in response to growing requests from pharmaceutical manufacturers and some consumer advocacy groups. See PhRMA, Facts & Figures: Direct-to-Consumer Advertising (visited Nov. 14, 1997) <http://www.phrma.org/facts/bkgrndr/advert.html> [hereinafter Facts & Figures].

10 See 62 Fed. Reg. at 43,171.

11 See Guidance for Industry: Consumer-Directed Broadcast Advertisements (visited Jan. 22, 1999) <http://www.fda.gov/cder/guidance/index.htm> [hereinafter Guidance].

12 See id.

13 See id.

14 Commentators have questioned whether the FDA is attempting to evade informal and formal rulemaking requirements by promulgating advisory opinions, interpretive rules and policy statements. Since the proposed Guidance is not part of rulemaking procedure, it can be argued that the FDA is not obligated to promulgate a final guidance. See generally Lars Noah, The FDA ‘s New Policy on Guidelines: Having Your Cake and Eating it Too, 47 CATH. U.L. Rev. 113 (1997).

15 See Greg Borzo, New FDA Rules for Advertising Drugs on TV Raises Questions, Am. Med. NEWS, Sept. 8, 1997, at 3, available in 1997 WL 9149598.

16 See Michael C. Allen, Medicine Goes Madison Avenue: An Evaluation of the Effect of Direct-to-Consumer Pharmaceutical Advertising on the Learned Intermediary Doctrine, 20 Campbell L. Rev. 113,113(1997).

17 See David Woodward, The New Drug Marketing: A Consumer Protection Perspective, 51 FOOD & DRUG L.J. 637, 637 (1996).

18 See Yumiko Ono, Magazines Spar With Television Over Drug Ads, Wall St. J., Oct. 6, 1997, at B6.

19 See Harris Meyer, The Pills That Ate Your Profits, HOSP. & Health Networks, Feb. 5, 1998, at 19,21.

20 See Chemical Market Reporter, Raising the Bar in Direct-to-Consumer Advertising, Chem. Bus. Newsbase, Dec. 11, 1998, available in LEXIS, News Library, TXTNWS File.

21 See Tamar Nordenberg, TV Drug Ads that Make Sense, Consumers’ Research Mag., Mar. 1998, at 28.

22 See id.; see also Milt Freudenheim, Influencing Doctor's Orders: Ads Help Sales of Prescription Drugs, but at What Cost?, N.Y. TIMES, Nov. 16, 1998, at CI.

23 See Andrea Rock, Prescription For Trouble, Money, Apr. 1998, at 114, 117 (noting that the FDA approved 92 new drugs in the last two years).

24 See 21 U.S.C. § 352(n) (1988).

25 See id.

26 See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997) (citing Arthur Hull Hayes, Jr., Commissioner of Food and Drugs, Direct-to-Consumer Advertising of Prescription Drugs: Moratorium (Feb. 17, 1983) (speech)).

27 See id.

28 See Lance S. Gilgore, A Consideration of Direct-to-Consumer Advertising of Prescription Drugs and Potential Legal Problems with the Brief Summary Requirement: Is the FDA ‘s Regulatory Authority Illusory?, 46 FOOD DRUG COSM. L.J. 849, 855 (1991) (citing FDA Statement of Policy: Direct-to-Consumer Advertising of Prescription Drugs, Moratorium, and cover letter (Sept. 2, 1983), at 1).

29 See Jeff Gelles, Prescription-Drug Advertisements Prompt Cheers, Fears: Onslaught of TV Commercials May Nudge People to Go See Their Doctors, or it Might Lead to Abuse, Seattle Times, Sept. 6, 1997, at A2, available in 1997 WL 3251794.

30 See Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg. 36,677 (1985).

31 See Gelles, supra note 29, at A2.

32 See id.

33 See Guidance, supra note 11.

34 See Draft Guidance For Industry; Consumer-Directed Broadcast Advertisements; Availability, 62 Fed. Reg. at 43,171-173; see also Guidance, supra note 11.

35 See 62 Fed. Reg. at 43,172.

36 See Jill Wechsler, Direct-to-Marketers: FDA Talks to the Industry, Pharmaceutical Executive, Dec. 1, 1997, at 52, available in 1997 WL 9141563.

37 See 62 Fed. Reg. at 43,171-173. This provision recognizes the inability of broadcast advertisements to present and effectively communicate the extensive information that would normally be included in a brief summary. See id. at 43,172. The adequate provision procedure tells the viewer to “ask your doctor” for additional information. See Letter from Warren Rumble, Regulatory Review Officer, Food & Drug Administration, on Notice of Violation to Ronald T. Garutti, M.D., Director of Marketed Products Support, Schering Corporation 1 (Aug. 19, 1997) [hereinafter Letter from FDA to Schering].

38 See Guidance, supra note 11.

39 See id.

40 See Wechsler, supra note 36, at 52.

41 See Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314, 24,315 (1997).

42 See id.

43 See DDMA C Calls Merck TV Commercial a ‘Model’ DTC Broadcast Advertisement, FDA Advertising and Promotion Manual (visited Oct. 14, 1998), <http://www.thompson.com/tpg/food/sell/selljulyl.html> [hereinafter DDMAC Calls]. Rezulin's advertisement was cited as one that failed to provide adequately risk information to patients. See Drug Ads Give Us Headaches, Doctors Say, HERALDLlNK (visited Jan. 18, 1999), <http://www.herald.corn:80/usa/digdocs/070265.htm>. The advertisement targeted the Hispanic population and was written in Spanish, however, the warning about liver failure was written in English. See id.

44 See Letter from FDA to Schering, supra note 37; Borzo, supra note 15, at 3.

45 See Borzo, supra note 15, at 3.

46 See id.

47 See id.

48 See id.

49 See id.

50 See id.

51 See id.

52 See id.

53 See id. The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) cited a good advertisement, Merck & Co. Inc.'s Propecia commercial. See DDMAC Calls, supra note 43. The FDA cited it as a model example of a compliant DTC broadcast advertisement. See id.

54 See Borzo, supra note 15, at 3.

55 See id.

56 See id.

57 See, e.g., 21 U.S.C. § 352 (1994).

58 See, e.g., FDA Modernization Act of 1995, H.R. 1742, 104 Cong., 1st Sess. § 502(a) (1995); see also Peter S. Reichertz, Legal Issues Concerning The Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 363 (1996) (citing American Association of Advertising Agencies Inc., Legislative Proposal Submitted to the Honorable Thomas J. Bliley, Chairman, House Commerce Committee (May 30, 1995)); H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1197, 104 Cong., 1st Sess. (1995); S. 1744, 104 Cong., 2d Sess. (1996).

59 See 21 U.S.C. § 352(n). At the time Congress considered enacting section 502(n) of the Kefauver-Harris Drug Amendments of 1962 (Pub. L. No. 87-781, 76 Stat. 780 (1962)), which permitted greater scrutiny concerning drug product promotion and provided that prescription drug advertisements must include a brief summary, DTC advertising of prescription drugs was not a visibly implemented or discussed topic. Therefore, consideration of DTC advertising is absent from legislative history. See Gilgore, supra note 28, at 851.

60 The Federal Trade Commission's (FTC) authority to regulate advertising is derived from section 5 of the Federal Trade Commission Act. See Federal Trade Commission Act, ch. 311, 38 Stat. 717 (1914) (codified at 15 U.S.C. §§ 52-55 (1994)).

61 See Pines, supra note 26, at 65 (discussing each agency's jurisdiction).

62 See James M. Serafino, Developing Standards for Health Claims — The FDA and the FTC, 47 FOOD & DRUG L. J. 335, 335 (1992) (citing Advertising in the ‘90s, Hon. Deborah K. Owen, Commissioner, Federal Trade Commission, Remarks to American Advertising Federation (Mar. 17, 1992)). The FTC has traditionally used FDA expertise in evaluating over-the-counter drug, cosmetic, food and device advertising claims. See Serafino, supra, at 337, 342-43 (citing examples of FTC attempts to harmonize FDA and FTC standards by using FDA determinations in regulating product claims).

63 See Memorandum of Understanding, 36 Fed. Reg. 18,538 (1971).

64 See Serafino, supra note 62, at 350-52 (comparing FDA and FTC standards for substantiating an alleged product claim).

65 See 21 C.F.R. §202.1 (1998).

66 See J. Howard Beales, III, Economic Analysis and the Regulation of Pharmaceutical Advertising, 24 Seton Hall L. Rev. 1370, 1382 (1994).

67 See FDll Views DTC Ads, Drugs on the Internet, Etc., Marketletter, Sept. 22, 1997, available in 1997 WL 11871304 [hereinafter FDLI Views].

68 See Ch. 540, 60 Stat. 427 (1946) (codified in scattered sections of 15 U.S.C.); .see also Pines, supra note 26, at 65.

69 See generally Linda R. Horton & Kathleen E. Hastings, A Plan That Establishes a Framework for Achieving Mutual Recognition of Good Manufacturing Practice Inspections, 53 FOOD & DRUG L.J. 527 (1998) (noting that the FDA regularly performs on-site inspections of production and distribution facilities to ensure compliance with its regulations).

70 See FDLI Views, supra note 67.

71 See Craig A. Marvinney, How Courts Interpret a Manufacturer's Communications to Consumers: The Learned Intermediary Doctrine, Al FOOD & DRUG L.J. 69, 70(1992).

72 See 56 F-D-C REP., (“The Pink Sheet”), Oct. 17, 1994, at 6; see also Med. Marketing & Media, Dec. 1994, at 18.

73 See Marvinney, supra note 71, at 70.

74 See Paul D. Colford, DTC Ads: Just What the Doctor Ordered, 7 Mediaweek 46 (Oct. 20, 1997).

75 See FDLI Views, supra note 67. The evaluation will collect factual and balanced data on the effect of DTC advertising on public health. See id.

76 See David Nagel, Pharmaceutical Advertisers Line Up with New DRTV Commercials, Response TV, Oct. l, 1997, at 14.

77 See id.

78 See Barbara J. Tyler & Robert A. Cooper, Blinded by the Hype: Shifting the Burden When Manufacturers Engage in Direct-to-Consumer Advertising of Prescription Drugs, 21 VT. L. Rev. 1073, 1099(1997).

79 However, demographics affect which consumers will be influenced by DTC advertisements. While the 40-and-older population accounts for $8.40 of every $10 of all prescription drug sales in the United States and are the overwhelming target for DTC advertisements, this demographic group is segmented into categories such as Proactives, Faithful Patients, Optimists and Disillusioned, each group of which is influenced in different ways, if at all, by DTC advertisements. See Carol Morgan & Doron Levy, To Their Health: Pharmaceutical Firms are Increasing Their Use of Direct-to-Consumer Advertising, BRANDWEEK, Jan. 19, 1998, at 30, available in 1998 WL 10236668. Pharmaceutical marketers take this into account when creating their marketing plans. See id.

80 See id.

81 See Allen, supra note 16, at 128.

82 Among the reasons some patients stop taking medication is to avoid certain painful side-effect. See id.

83 See Gelles, supra note 29, at A2.

84 See Debi Reissman, New Drugs and DTC Advertising: Friend or Foe?, 10 Drug Benefit Trends 16 (1998), (visited February 26,1999) <http://www.medscape.com/SCP/DBT/1998/vl0.n06/d4847.reis.html>.

85 See Gelles, supra note 29, at A2.

86 See Tyler & Cooper, supra note 78, at 1082.

87 See id.

88 See id.

89 See Gelles, supra note 29, at A2.

90 See id. (discussing a case of a man suffering from abdominal pain who wanted a prescription ulcer drug, but was actually suffering from a gastric ulcer). However, pharmaceutical companies argue that a drug advertisement can save a patient's life by getting him or her to the doctor's office. See id.

91 See Marjorie Kauffman Sherr & Donna Cutrone Hoffman, Physicians—Gatekeepers to DTC Success, Pharmaceutical Executive, Oct. 1, 1997, at 56, available in 1997 WL 9141553.

92 See id. (stating DTC advertisements are directed toward an audience that generally lacks adequate education about pharmaceuticals and an understanding of the factors involved in a medical decision, thereby creating false expectations).

93 See Colford, supra note 74, at 47.

94 See id. (stating that, in a survey of 5,000 physicians and 5,000 patients, three-quarters of the physicians said patients talked about the contents of DTC advertisements and 88% of those patients asking their physician for a drug did so by brand name).

95 See Elyse Tanouye, Drug Ads Spur Patients to Demand More Prescriptions, Wall St. J., Dec. 22, 1997, at Bl, available in 1997 WL-WSJ 14178341.

96 See id.

97 See id.

98 See id.; see also Gloria Lau, Doc's Just an Employee Now, FORBES, May 18, 1998, at 162, available in 1998 WL 2087040.

99 See Tanouye, supra note 95, at Bl.

100 See Gelles, supra note 29, at A2.

101 See id.

102 See id.

103 See id.

104 See Sherr & Hoffman, supra note 911, at 56 (reporting the results of a study that revealed physician concerns and how pharmaceutical companies can take physician needs into their DTC marketing decisions).

105 See id.

106 See id. (stating DTC advertisements are superficial because they fail to educate patients about ramifications, such as product indications, effectiveness and side-effects).

107 See id. One doctor commented that it is much easier to take care of informed patients who take some responsibility for their health care versus someone who does not want to be informed or to take responsibility. See Joyce Clark Hicks, Healthy Trend?, The news & Observer, Jan. 22, 1998, at El, available in 1998 WL 6123324.

108 See Sherr & Hoffman, supra note 911, at 81. Forty-one percent believe that DTC initiatives generally “both educate and confuse patients in equal doses.” Id.

109 See Tanouye, supra note 955, at Bl.

110 See Sherr & Hoffman, supra note 911, at 56.

111 See Lee Weinblatt, DTC Advertisers—You ‘re Wasting Your Money, Med. Marketing & Media, NOV. 1, 1997, at 46, available in 1997 WL 9909893.

112 See id. (questioning why physicians would change a drug that is working for a patient and also risk getting in trouble with their health maintenance organization (HMO)).

113 See Sherr & Hoffman, supra note 91, at 56. Pharmaceutical sales representatives are currently reluctant to discuss DTC advertising because they may be faced with a negative reaction from physicians. Pharmaceutical companies should develop programs and materials to help their representatives better handle DTC issues with physicians. See id.

114 See Stephen P. Mahinka, et al., Effect of MCOs on Drug Sales, NAT'L L.J., Sept. 15, 1997, at B4.

115 Managed care organizations would rather keep generic drugs on their formularies, as they are much less expensive, and therefore are against DTC advertising. See William G. Castagnoli, The Coming Showdown on DTC; Regulation on Direct-to-Consumer Advertising for Prescription Drugs, Med. Marketing & Media, Sept. 1998, at 40, available in 1998 WL 14841048.

116 One such HMO, Medica Health Plans of Minnesota, recently chose to offer an open-formulary plan because of the increasing number of pharmaceutical products being advertised directly to the public. See Managed Care: Leading Minnesota HMO Opens Formulary for Higher Copayment, 5 HEALTH CARE POL'Y REP. (BNA) 1751, 1782 (Nov. 24, 1997). Medica Health Plans anticipated continued pressure to expand its formulary, even though it believes that the drugs it offered were effective and handled most patients’ needs. See id.

117 See Robert McCarthy, Managed Care Matters—Direct-to-Consumer Ads and Cosmetic Pharmacology, 10 Drug Benefit Trends 18, June 1998 (visited Feb. 26, 1999) <http://www.medscape.com/SCP/DBT1998/vl0.n06/d4253.mcca/d4253.mcca-01.html>.

118 See id.

119 Id . (“My per-member/per-month expense for cholesterol reducers is up 22%, and for proton-pump inhibitors, it's up 26%.) (quoting Otto Wolke, Vice President, Pharmacy Services, Geisinger Health Plan).

120 See id.

121 See id. One pharmaceutical benefit manager executive points out that “if you cover every drug that every patient wants because he's seen it on television, that means diverting resources from areas like, say, immunizations, where you get an amazing cost/benefit pay-back, and where you really do positively impact patient health.” Id. at <http://www.medscape.com/SCP/DBT1998/vl0.n06/d4253.mcca/d4253.mcca-02.html>. Strategies to deal with advertising-stimulated patient demand include: (1) adjusting percentage copays to increase for high-cost drugs of questionable medical necessity; (2) excluding certain drugs altogether, or restricting usage to very precise indications; and (3) implementing “demand-management ‘nurselines’ to get patients the information that might forestall, to some extent, inappropriate consumer expectations.” Id. at <http://www.medscape.com/SCP/DBT1998/vl0.n06/d4253.mcca/d4253.mcca-03.html>.

122 See Gelles, supra note 29, at A2.

123 See Meyer, supra note 19, at 20.

124 See id. at 21. Some of the HMOs facing big losses are Oxford Health Plans, PacifiCare Health Systems, Maxicare and United Healthcare. See id. The cost increases for the HMOs due to pharmaceutical costs range from 10 to 25%. See id.

125 See id.

126 See Wechsler, supra note 36, at 52.

127 See id.

128 See 44 Liquormart v. Rhode Island, 517 U.S. 484, 502 (1996) (protecting commercial speech which is “truthful, [and provides] non-misleading information [to consumers]” from being abridged); see also U.S. CONST, amend. I; Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C.) (1998) (partially holding that government restrictions on pharmaceutical manufacturer promotional activities for off-label uses were more extensive than necessary and would unnecessarily burden an important form of speech).

129 See Gelles, supra note 29, at A2.

130 See Morgan & Levy, supra note 79, at 30. In addition to demographic information, pharmaceutical executives are increasingly knowledgeable about and recognize regional difference (such as the incidence of disease, differences in HMO penetration, styles of physician practice, sales force strength and activity and percentage of insured population) when creating DTC marketing plans. See id.

131 See Yumiko Ono, Drug Marketers Learn to Craft a Slicker Pitch, WALL ST. J., Feb. 11, 1998, at Bl (noting that pharmaceutical manufacturers are learning about DTC advertising without much guidance).

132 Merck's drug Zocor and Schering-Plough's antihistamine Claritin benefited from DTC advertising that was reflected in strong sales growth in the fourth quarter of 1997. See Four Drug Cos. Earnings-2: Merck, Schering-Plough Beat Views, DOW JONES NEWS SERV., Jan. 27, 1998. In addition, a toenail fungus drug, Sporanox, made by Johnson & Johnson, more than doubled doctor visits for toenail fungus since 1993, 39% of which resulted in a prescription for Sporanox. See Tanouye, supra note 95, at Bl.

133 See Wechsler, supra note 36, at 52. If, however, a pharmaceutical company submits a new promotion through the DDMAC's optional preclearance process, objections to an advertisement will be conveyed privately, thus sparing the company from bad publicity. See id.

134 See Milton Liebman, FDA Takes the Mystery Out of TV Ads, Med. Msarketing & Media, Sept. 1, 1997, at 34 (“there may be greater exposure to lawsuits because of the open interpretation of the wording that should be in the advertisement risk message”).

135 See Burton, et al. v. American Home Products Corp., Nos. MDL 1038, l:95-CV-5360, 1:95-CV-5718, I:95-CV-5243, l:95-CV-5229, 1997 U.S. Dist. WL 222926, at *1 (E.D. Tex. Apr. 9, 1997); see also Teresa Moran Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG Cosm. L.J. 829 (1991) (discussing court receptiveness of the advertising exception to the learned intermediary rule).

136 See Joseph G. Blute, Courts Struggle with the Learned Intermediary Rule Exceptions, Prod. Liab. L. & Strategy, May 1997, at 3, 3.

137 See Tyler & Cooper, supra note 78, at 1077.

138 See id. at 1080.

139 See id. at 1081. There have been some recent development concerning the learned intermediary doctrine. In 1997, the American Law Institute (ALI) approved the Restatement Third of Torts: Product Liability. The revised Restatement contains rules that are specifically applicable to pharmaceutical products that suggest that pharmaceutical manufacturers may now have a broader duty to warn consumers directly about these products. While the new Restatement does not eliminate the learned intermediary doctrine, the drafters did try to create an exception related to DTC advertising, but it was not adopted. The final version explains that the ALI “takes no position on the issue and leaves it for developing case law.” Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 GA. L. Rev. 141, 143-44 (1997).

140 See, e.g., Crisostomo v. Stanley, 857 F.2d 1146 (7th Cir. 1988).

141 See id. 1152-53 (“[A] drug manufacturer's … liability turns on whether it sufficiently warned [the prescribing physician] of a drug's dangerous propensities … . [The] drug manufacturer is only liable [to the patient] for failure to warn if it had knowledge or reason to know of the danger that cause the injury”).

142 See Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 301-02 (Okla. 1997) (holding manufacturer liable for the wrongful death action where decedent suffered a nicotine overdose resulting from continued smoking and the overuse of prescription nicotine patches).

143 See id. at 303-04.

144 See Garside v. Osco Drug Inc., 764 F. Supp. 208, 211 n.4 (D. Mass. 1991) (“By advertising directly to the consuming public, the manufacturer bypasses the traditional patient-physician relationship, thus lessening the role of the learned intermediary.”). ALI left this question open in its recently adopted Restatement (3d) of Products Liability. See Bob Van Voris, Drug Ads Could Spell Legal Trouble, NAT'L L.J., July 21, 1997, at Bl, available in WL 7/21/97 NLJ Bl (col. 4).

145 See Van Voris, supra note 144, at Bl. Courts have also concluded that when prescription pharmaceuticals are overpromoted to physicians, physicians tend to overprescribe those drugs. Thus, judges may consider the extent and nature of the impact of advertising in their determination of the adequacy of a pharmaceutical manufacturer's warnings. See Tyler & Cooper, supra note 78, at 1089.

146 See Tyler & Cooper, supra note 78, at 1095.

147 See Facts & Figures: Direct-to-Consumer Advertising, supra note 9.

148 See Beales, supra note 66, at 1374-75.

149 See Inside the Industry: Eli Lilly Issues Direct-to-Consumer Ad Guidelines, Am. Health Line, Mar. 31, 1998, at 9, available in WL 3/31/98 APN-HE 9.

150 Id.

151 Id.

152 The pharmaceutical industry spent $1 billion in 1997 and an estimated $1.4 billion in 1998. See Meyer, supra note 19, at 21; Raising the Bar in Direct-to-Consumer Advertising, supra note 20. The advertising industry does not foresee a decline in pharmaceutical manufacturer spending because manufacturers are profiting from advertisements. See id.

153 See Gelles, supra note 29, at A2.

154 See Sherr & Hoffman, supra note 91, at 56.

155 See Gelles, supra note 29. Estimates show that pharmaceutical manufacturers invested $1.4 billion on DTC advertising in 1998. See Raising the Bar in Direct-to-Consumer Advertising, supra note 20.

156 See Borzo, supra note 15, at 3.

157 See Gelles, supra note 29, at 2.

158 See Borzo, supra note 15, at 3.

159 See Ann Marie Kerwin, Magazines will fight to keep Rx ad bounty: Publishers fear shift of spending to TV under relaxed FDA Regs, ADVERTISING AGE, Sept. 15, 1997, at 8.

160 See id. While magazines have lost some growth to television ads, overall there has been an increase in total spending. See Ann Marie Kerwin, Magazines keep going strong with 3.6% page gain, Advertising Age, Nov. 2, 1998, at 18.

161 See Ono, supra note 18, at B6.

162 See id.

163 See id.

164 See Morgan & Levy, supra note 79, at 30.

165 See Ono, supra note 131, at Bl (discussing NBC's refusal to air a commercial for Muse, a prescription treatment for impotent men, during the 1998 Super Bowl).

166 See Gelles, supra note 29 (“Physicians, pharmacologists and consumer advocates who are critical of the ads say they distort doctor-patient relationships and threaten to lead to increases in the misuse of prescription drugs.”).

167 See Hicks, supra note 107, at El.

168 See Beales, supra note 66, at 1374.

169 See Gelles, supra note 29, at A2.

170 See Michael Jonathan Grinfeld, Ad Campaign Targets Depression, Psychiatric Times, Sept. 1997, (visited Jan. 25, 1999) <http://www.mhsource.com/edu/psytimes/p970901.html>.

171 See Borzo, supra note 15, at 3.

172 Bruce Mirken, A Dangerous Sales Pitch?, SF Bay Guardian: Epicenter (Oct. 23, 1996).

173 See American Medical Association, Principles of Medical Ethics (visited Feb. 10, 1999) <http://www.ama-assn.org/ethic/pome.htm> (stating that physicians have an ethical duty to “deal honestly with patients” and to “respect the law”). When a physician knowingly prescribes a medication without proper consideration for the patient, the physician could be liable on medical malpractice grounds.

174 See US Doctors View DTC Ads for Prescription Drugs, MARKETLETTER, Sept. 1, 1997, available in 1997 WL 11871103 (“Internist and Cardiologist Thomas Lee told the New York Times that when patients come in asking if they should be on a particular medication, they are mildly suspicious that the doctor ‘has blown it’ by not treating them with [that medication].”).

175 See Woodward, supra note 17, at 638.

176 See Borzo, supra note 15, at 3.

177 See id.

178 See id.

179 See id.

180 See Mirken, supra note 172.

181 See Nagel, supra note 76, at 14.

182 See id.

183 See Colford, supra note 74, at 48.

184 See Michael Wilke, Experience Pays as Glaxo Wellcome Wins Over Consumers, Advertising Age, Oct. 20, 1997, at S12. Others believe that one of the purposes of DTC advertisements is to destigmatize certain diseases such as depression. See Grinfeld, supra note 170.

185 See Linda Gorov, AIDS Drug Makers Aim Pitch Right at Patients, BOSTON GLOBE, Oct. 13, 1997, at CI.

186 See Colford, supra note 74, at 48.

187 See Borzo, supra note 15, at 3.

188 See Morgan & Levy, supra note 79, at 30.

189 See Woodward, supra note 17, at 131.

190 See id. at 132.