1 Darren Rovel, The Burden of Pitching Pills, ESPN (Nov. 19, 2004), http://www.espn.com/espn/sportsbusiness/news/story?id=1927023 [https://perma.cc/B39S-AMDN]. “In April [2015], Bruce Jenner spoke about her transformation to being a woman.” Ravi Somaiya, Caitlyn Jenner, Formerly Bruce, Introduces Herself in Vanity Fair, N.Y. Times (June 1, 2015), https://www.nytimes.com/2015/06/02/business/media/jenner-reveals-new-name-in-vanity-fair-article.html [https://perma.cc/GLF8-E86D].

2 Rovel, supra note 1.

3 Other such popular pharmaceutical/celebrity teams of the past and present include: Chris Bosh, Arnold Palmer, Brian Vickers, and Kevin Nealon with Bayer/Johnson & Johnson (Xarelto, an anticoagulant); Mike Ditka with Merck (Zocor, lipid-lowering agent); Sally Field with Roche/GlaxoSmithKline (Boniva, an osteoporosis treatment); Larry the Cable Guy with Proctor & Gamble (Prilosec, a heartburn treatment); and Brooke Shields with Allergan (Latisse, an eyelash-growth treatment). See 50 Celebrity Healthcare Endorsements, Med. Mktg. & Media (Feb. 9, 2016), http://www.mmm-online.com/campaigns/50-celebrity-healthcare-endorsements/article/471671/ [https://perma.cc/T65T-T8VD].

4 The other being New Zealand. See Every-Palmer, Susanna, Rishi Duggal & David B Menkes, Direct-to-Consumer Advertising of Prescription Medication in New Zealand, 127 N.Z. Med. J. 102, 103 (2014)Google ScholarPubMed (“Such industry funded ‘health information’ campaigns have been banned in almost all industrialized countries since the 1940s. New Zealand and the United States are lonely exceptions.”).

5 Ray Moynihan, The Intangible Magic of Celebrity Marketing, 1 PLoS Med. 102 (Nov. 30, 2004).

6 See Learning About Side Effects, Food & Drug Admin., https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm196029.htm [https://perma.cc/AD9W-MC77] (last visited Feb. 18, 2017) (“Side effects can vary from minor problems like a runny nose to life-threatening events, such as an increased risk of a heart attack.”); see also Susan Farrell, Harmful Effects of Supplements Can Send You to the Emergency Department, Harv. Health Blog (Oct. 15, 2015, 10:04 AM), http://www.health.harvard.edu/blog/harmful-effects-of-supplements-can-send-you-to-the-emergency-department-201510158434 [https://perma.cc/P3W2-8FKK] (“They can also cause unwanted effects, such as elevated blood pressure, racing or irregular heartbeat, headache, dizziness, or digestive symptoms.”).

7 Memorandum of Understanding Between the Fed. Trade Comm’n and the Food and Drug Admin., MOU 225-71-8003 (1971), http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm [https://perma.cc/L7B8-C955].

8 Id.

9 Donohue, Julie, A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection, 84 Milbank Q. 659, 662 (2006)CrossRefGoogle ScholarPubMed.

10 Id. at 660 (“[T]he pharmaceutical industry … for decades had focused its promotional efforts solely on physicians ….”).

11 Id. at 675.

12 Id. See also FDA, Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg. 36,677, 36,677 (Sept. 9, 1985) (describing the events leading up to moratorium, including newspaper print advertising of a drug to treat herpes).

13 Id.

14 Id.

15 Id.

16 Kerry Segrave, Endorsements in Advertising: A Social History 150-51 (2005).

17 >Claudia H. Deutsch, The Brouhaha Over Drug Ads, N.Y. Times (May 14, 1989), http://www.nytimes.com/1989/05/14/business/the-brouhaha-over-drug-ads.html?pagewanted=all.

18 Bruce Ingersoll, Advertising: Prescriptions Touted by Stars are Investigated, Wall St. J., Sept. 17, 1991, at B1.

19 Segrave, supra note 16, at 150; Michael Wilke, FDA Gives OK for Claritin to Use Celebrity Endorser: DTC Ads Starring Lunden are Latest Step into Mainstream, AdvertisingAge (July 13, 1998), http://adage.com/article/news/fda-claritin-celebrity-endorser-dtc-drug-ads-starring-lunden-latest-step-mainstream/65151/ [https://perma.cc/3YHT-YL5A].

20 Segrave, supra note 16, at 151.

21 Siva K. Balasubramanian, Beyond Advertising and Publicity: Hybrid Messages and Public Policy Issues, 23 J. Advert. 29, 33 (Dec. 1994).

22 Actual amounts received by specific individuals are confidential, however. Moynihan, supra note 5, at 103 (Nov. 30, 2004). This estimate is also a decade old. The numbers are sure to have risen since, but due to confidentiality of such agreements, current estimates are speculative.

23 See examples, supra note 3.

24 See infra Part IV. B. for a further discussion of the implications of this phenomenon.

25 See Moynihan, supra note 5.

26 For example, when Kelsey Grammer and his wife promoted awareness of IBS, viewers thought they were speaking for an independent organization, when their speaking fees were actually being paid by GlaxoSmithKline immediately prior to bringing an IBS treatment drug onto the market. See infra Part IV. B.

27 See Megan Thielking, Celebrity Selfies, Lax Regulations Drive Booming Supplement Industry, Stat (Nov. 16, 2015), https://www.statnews.com/2015/11/16/celebrity-selfies-lax-regulations-drive-booming-supplement-industry/. [https://perma.cc/X65W-GXTE].

28 See Megan Thielking, Unregulated Supplements Send Thousands to Hospital Each Year, Bos. Globe (Oct. 14, 2015), https://www.bostonglobe.com/metro/2015/10/14/diet-pills-and-other-unregulated-supplements-send-thousands-hospital-each-year/7HG6mwrdujYCB7ZMo5RHuM/story.html. [https://perma.cc/VEF7-SL25]

29 Guides Concerning Use of Endorsements and Testimonials in Advertising, 16 C.F.R. § 255.1 (2016) (“Endorsements must reflect the honest opinions, findings, beliefs or experience of the endorser” and “[w]hen the advertisement represents that the endorser uses the endorsed product, the endorser must have been a bona fide user of it at the time the endorsement was given.”).

30 Only two of six celebrities responded to the inquiry. Celebrity Endorsements: Who’s Selling What: Don’t Be Starstruck by Supplements, Consumer Rep. (Mar. 2012), available at http://www.consumerreports.org/cro/magazine/2012/03/celebrity-endorsements-who-s-selling-what/index.htm. [https://perma.cc/MWE8-SK9H].

31 Id.

32 Id.

33 In exchange for 50 Cent’s endorsement for Vitamin Water, he received a minority ownership in Glaceau, the company that produced the product. When Glaceau was sold to Coca-Cola, 50 Cent received about $100 million. Andrew Barker, Branded Within an Inch of Their Lives, 319 Variety 67, 68 (Apr. 16, 2013), http://variety.com/2013/music/features/endorsement-deals-1200334594/.

34 See supra note 27.

35 See supra note 28.

36 Id.

37 See supra notes 18-26.

38 Jen Christensen & Jacque Wilson, Congressional Hearing Investigates Dr. Oz ‘Miracle’ Weight Loss Claims, CNN (June 19, 2014), http://www.cnn.com/2014/06/17/health/senate-grills-dr-oz/ [https://perma.cc/A2LP-R2FJ].

39 See, e.g., Steven Ross Pomeroy, Dr. Oz Has Found 16 Weight Loss ‘Miracles.’ So Why Is There Still an Obesity Epidemic?, Forbes (Jan. 10, 2014), http://www.forbes.com/sites/rosspomeroy/2014/01/10/dr-ozhas-found-16-weight-loss-miracles-so-why-is-there-still-an-obesity-epidemic/#632e8605445b.

40 Id.

41 See Christensen & Wilson, supra note 38 (“A 1998 study of 135 participants found Garcinia cambogia did not significantly help people lose weight any more than a placebo. But a 2013 meta-analysis of Garcinia cambogia studies hedged on the supplement's ineffectiveness, saying its weight loss benefits ‘remain to be proven in larger-scale and longer-term clinical trials.’ Whether it helps people lose weight or not, the Garcinia cambogia does not seem to be unsafe to use, some other studies say.”).

42 Angela Haupt & Deborah Kotz, The Dangers of Kardashian-Endorsed QuickTrim, U.S. News (Mar. 5, 2012), http://health.usnews.com/health-news/diet-fitness/articles/2012/03/05/the-dangers-of-kardashian-endorsed-quicktrim-2 [https://perma.cc/PW7M-ESCQ].

43 Id. A physician’s analysis of some of the QuickTrim products – “Burn & Cleanse 14 Day Diet System,” “Fast Cleanse,” and “Sugar & Carb Cheater” – notes problems including that the labeling does not indicate the levels of caffeine in the products or the presence of laxatives at the levels causing diarrhea and dehydration, and that the labeling overall is making claims that give people false hope. Id.

44 FDA, Memorandum of Understanding Between the Federal Trade Commission and the Food & Drug Administration, MOU 225-71-8003 (1971), http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm [https://perma.cc/9NQD-XQNG]. [EN – Can this be supra to note 7??]

45 Id.

46 Id.

47 See supra notes 44-46 and accompanying text.

48 See, e.g., Kordel v. United States, 335 U.S. 345, 351 (1948) (“Every labeling is in a sense an advertisement.”).

49 Kim Schmid, Gray Zone Between FDA and FTC Neutraceutical Regulation, Law360 (Aug. 13, 2013), http://www.law360.com/articles/464369/gray-zone-between-fda-and-ftc-nutraceutical-regulation.

50 Warning Letter from FDA to Phusion Projects, Inc. (Nov. 17, 2010), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm234023.htm [https://perma.cc/H6SM-YK66]. The FDA further stated that under the conditions of use, caffeine was not GRAS, and thus the beverage was adulterated in violation of the FDCA. Id.

51 Letter from FTC Bureau of Consumer Protection Division of Advertising Practices to Andrew J. Strenio, Re: Notice of Potentially Illegal Marketing of Caffeinated Alcohol Products (Nov. 17, 2010), https://www.ftc.gov/sites/default/files/documents/public_statements/potentially-illegal-marketing-caffeinated-alcohol-products/phusionletter.pdf [https://perma.cc/DZ2U-HH2K].

52 Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(m) (2012).

53 See Kordel v. United States, 335 U.S. 345, 348-50 (1948) (holding that a mailed pamphlet about a drug constituted “labeling” even though the pamphlet did not accompany the drug, persuaded by the fact that the pamphlet and the product had a “common origin and a common destination”).

54 Wilson v. Frito-Lay North America, Inc., 961 F.Supp.2d 1134, 1143 (N.D. Cal. 2013) (holding that a website printed on a Frito-Lay chip package was not labeling, in part because the website was as general link, and not placed near the nutritional values, for example, which might intimate the website was attempting to supplement the printed label).

55 See About Us, BioMedBalance.com, http://biomedbalance.com/home/about-us [https://perma.cc/5EJC-RZXP].

56 FDA Warning Letter to Raymond W. Szeto, President of NutriResearch, Inc. (Nov. 15, 2016), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529991.htm [https://perma.cc/JLA7-3HA7].

57 Id.

58 It is important to note that even though the guidelines themselves are non-binding, the FDA uses guidelines as a basis for some of its warning letters, and the industry typically use the guidelines to dictate companies’ behavior. See generally, “Even the FDA is Keeping Up With the Kardashians,” Law360 (Aug. 20, 2015), https://www.law360.com/articles/692798/even-the-fda-is-keeping-up-with-the-kardashians [https://perma.cc/3HT3-8YHS].

59 Food, Drug, and Cosmetics Act, 21 U.S.C. §§ 331, 393 (2016).

60 Id.

61 See Part III, supra.

62 Segrave, supra note 16, at 146-58.

63 Id.

64 Prescription-drug Advertisements, 21 CFR § 202.1 (2016).

65 21 CFR § 202.1(a)-(e).

66 21 CFR § 202.1(e)(3)(i).

67 Letter from Robert Dean, Div. Dir., Office of Prescription Drug Promotion, to Eric Gervais, Exec. Vice President, Duchesnay, Inc. (Aug. 7, 2015) [hereinafter Duchesnay Warning Letter], http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf [https://perma.cc/M5JE-ERT6].

68 Id.

69 Id. Such incomplete information renders the drug misbranded in accordance with 21 U.S.C. §§ 321(n), 331(a), 352(a), 352(n).

70 Id. (“DICLEGIS is contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation, as well as in women who are taking monoamine oxidase inhibitors (MAOIs). The PI for DICLEGIS includes Warnings and Precautions regarding activities requiring mental alertness and concomitant medical conditions. In addition, the most common adverse reaction reported with DICLEGIS was somnolence.”).

71 Diclegis Corrective Ad, Kim Kardashian West (@kimkardashian), Instagram (Aug. 30, 2015), https://www.instagram.com/p/7B07j_uSww/ [https://perma.cc/REE6-7B8P].

72 FDA notes that while the link was included, such inclusion “[did] not mitigate the misleading omission of risk information.” Duchesnay Warning Letter, supra note 67. The negative treatment of external links (or the “one click rule”) for providing consumers with risk information is consistent with current FDA Guidance on the issue. See FDA, Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices: Draft Guidance 9 (proposed June 2014) [hereinafter FDA, Character Space Limitations Guidance], http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401087.pdf (indicating that at a minimum, the most serious risks associated with a drug should be conveyed alongside the cited benefits, and a link may be included to provide further risk information).

73 See, e.g., FDA, Character Space Limitations Guidance, supra note 72.

74 See discussion infra notes 90-97 and accompanying text.

75 See, e.g., FDA, Guidance for Industry: Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program: Draft Guidance 1 (proposed Mar. 2012) [hereinafter FDA, Pre-Dissemination Review Program Guidance], http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295554.pdf (including the disclaimer, “This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance….”).

76 FDA, Search for FDA Guidance Documents, FDA.gov, https://www.fda.gov/RegulatoryInformation/Guidances/ucm2005656.htm#about [https://perma.cc/QVG4-B5B4] (last updated Feb. 18, 2017) (filter results using “Advertising” subject field).

77 The first guidance relating to advertising was released in November 1997, but focused solely on scientific and educational activities. Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074, 64,093 (Dec. 3, 1997). In this guidance, the FDA notes that it will not seek to enforce scientific and educational activities if they are wholly separate and not influenced by the supporting company. Id. at 64,096.

78 FDA, Guidance for Industry: Consumer-Directed Broadcast Advertisements (Aug. 1999), https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125064.pdf.

79 Id.

80 Food, Drug, and Cosmetic Act, 21 U.S.C. § 352(n) (2012); 21 C.F.R. § 202.1(e)(1) (2016).

81 FDA, Consumer-Directed Broadcast Advertisements, supra note 78, at 2-3. The Q&A document states that the best practice is to include all four resources for consumers in the advertisements so they can use the one that is best for them.

82 FDA, Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion (proposed May 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf.

83 Id. at 5.

84 See Haupt & Kotz, supra note 42 and accompanying text.

85 FDCA, 21 U.S.C. § 353(c) (2012). FDA, Pre-Dissemination Review Program Guidance, supra note 75.

86 21 U.S.C. § 353c(a).

87 21 U.S.C. § 353c(c); FDA, Pre-Dissemination Review Program Guidance, supra note 75 (the statute does allow the FDA to require a specific risk disclosure if the advertisement is false and misleading without such disclosure).

88 Id.

89 Id. at 2.

90 This suggestion would more likely come to fruition if lobbying efforts could encourage Congress to amend the FDCA for purposes of allowing the FDA to require pre-review of certain Internet advertisements. FDA should be able to prevent misleading ads from ever being posted in the first place, as the Diclegis controversy demonstrates.

91 Mark Hughes, The Millennial Trends That Are Killing Cable, Forbes (Mar. 21, 2015), http://www.forbes.com/sites/markhughes/2015/03/21/the-millennial-trends-that-are-killing-cable.

92 See Stephanie M. Lee, Big Pharma is Coming for Your Facebook and Twitter Feeds, BuzzFeed (Dec. 21, 2016, 12:02 PM), https://www.buzzfeed.com/stephaniemlee/pharma-social-media [https://perma.cc/WJC8-5LMC].

93 FDA, Character Space Limitations Guidance, supra note 72.

94 Id.; FDA, Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (proposed June 2014) [hereinafter FDA, Correcting Third-Party Misinformation], http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf.

95 FDA, Correcting Third-Party Misinformation, supra note 94, at 2-3 (also noting that some cases may be easier for the manufacturer to respond to third-party misinformation and not as easy in other cases).

96 Id.

97 See FDA, Character Space Limitations Guidance, supra note 77, at 4.

98 I suspect the latter.

99 See supra notes 44-46 and accompanying text.

100 FTC Bureau of Consumer Prot., Dietary Supplements: An Advertising Guide for Industry 3 (2001), https://www.ftc.gov/system/files/documents/plain-language/bus09-dietary-supplements-advertising-guide-industry.pdf (evidentiary standards are provided throughout the guide).

101 See id. at 18 (explaining that it is also not sufficient that the statement be the endorser’s own opinion – the statement must be substantiated with evidence).

102 See, for example, the Kylie Jenner Lip Challenge that led many teenage girls to attempt to plump up their lips like Kylie’s by sucking the air out of a shot glass. Unfortunately, that friction often caused the glass to break, leading to thousands of injuries, many requiring stitches. Justin Wm. Moyer, Kylie Jenner Lip Challenge: The Dangers of “Plumping that Pout”, Wash. Post (Apr. 21, 2015), https://www.washingtonpost.com/news/morning-mix/wp/2015/04/21/kylie-jenner-challenge-the-dangers-ofplumping-that-pout/?utm_term=.f68ba731b90e [https://perma.cc/LJV3-MUFX].

103 See Katie Couric Effect discussed infra at notes 151-53 and accompanying text.

104 FTC, Guides Concerning the Use of Endorsements and Testimonials in Advertising, 16 C.F.R. § 255.0 (2016).

105 16 C.F.R. §§ 255.1(a)-(b) (2016).

106 16 C.F.R. § 255.5, ex. 3.

107 Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011).

108 Id. at 558-60 (allowing an exception if physicians gave consent). It is common practice for pharmaceutical companies to use prescriber-specific data for purposes of directing their marketing. See id. at 558. For example, a drug manufacturer may market their drug X more vigorously to Dr. A, who has been prescribing their competitor’s drug at a higher rate than drug X.

109 Id. at 557.

110 The Court offered less-restrictive alternatives, such as merely limiting physicians from meeting with manufacturers who use physician-identifying information in their usual marketing practices. Id. at 576-77.

111 United States v. Caronia, 703 F.3d 149, 168-69 (2d Cir. 2012).

112 Id. at 152. The FDCA outlines various ways in which a drug may be misbranded. A drug is misbranded if its label does not bear “adequate directions for use.” Food, Drug, and Cosmetic Act § 502(f), 21 U.S.C. § 352(f) (2012). The FDA interprets this section to mean that off-label marketing of a drug constitutes misbranding because the off-label promotion fails to provide “adequate directions for use.” See FDA, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices: Guidance for Industry, (proposed Jan. 2009) (also recognizing that truthful and non-misleading scientific information regarding off-label uses provides value to public health in general, as well as to health care professionals).

113 Caronia, 703 F.3d at 155-56.

114 Id. at 156-57. Carnoia was recorded saying “It’s a very safe drug,” and citing that the drug could be used for unapproved indications such as insomnia, fibromyalgia, and Parkinson’s. Id. He also promoted the drug as being safe for use in children under sixteen, though the FDA had not approved such use. Id.

115 Id. at 152.

116 Id. at 168-69.

117 See Sorrell v. IMS Health, 131 S. Ct. 2653 (2011); Caronia 703 F.3d; Amarin Pharma v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

118 FDA, Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices (Feb. 2014)

119 Id. at 6-7.

120 Id. at 7-17.

121 Id. at 3-4.

122 Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

123 Id. at 219. Vascepa is a triglyceride-lowering drug approved for one use (patients with triglyceride levels above 500 mg/dL of blood) by the FDA, but widely and lawfully prescribed off-label by physicians. Id. at 198.

124 Id. at 209.

125 Id. at 212.

126 Id. at 226 (“Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”).

127 Deborah Mazer & Gregory Curfman, FDA Sanctions Off-Label Drug Promotion, Health Affairs Blog (July 19, 2016), http://healthaffairs.org/blog/2016/07/19/fda-sanctions-off-label-drug-promotion/ [https://perma.cc/2FAZ-7V9H].

128 Id.

129 Katie Thomas, F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use, N.Y. Times (Mar. 8, 2016), http://www.nytimes.com/2016/03/09/business/fda-deal-allows-amarin-to-promote-drug-for-off-label-use.html [https://perma.cc/7GL2-X2KS] (citing Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group in Washington).

130 See Dana A. Elfin, FDA Settlement with Amarin May Limit Impact on Policy, Bloomberg BNA (Mar. 10, 2016), https://www.bna.com/fda-settlement-amarin-n57982068383/ [https://perma.cc/S2X8-E7JA] (quoting Richard A. Samp, chief counsel of the Washington Legal Foundation, “Indeed, [the FDA] is settling precisely because it doesn’t want to alter its stance….”).

131 King & Spaulding, Client Alert: Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case, at 4 (Mar. 9, 2016), http://www.kslaw.com/library/publication/ca030916.pdf [https://perma.cc/6L28-E9PT]. King & Spaulding also interprets another settlement between the FDA and Pacira Pharmaceuticals as an indication that the FDA must begin re-evaluating its position on off-label promotions, with the hope that the FDA will loosen its restrictions on such marketing. Id. at 5-6. For a more in depth look at the FDA/Pacira settlement, see Ropes & Gray, Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA (Dec. 16, 2015), https://www.ropesgray.com/newsroom/alerts/2015/December/Ropes-Gray-Advises-Pacira-Pharmaceuticalsin-Reaching-Landmark-Settlement-Agreement-with-FDA.aspx [https://perma.cc/LS6Q-7QZU].

132 FDA, Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments, 81 Fed. Reg. 60,299 (Sept. 1, 2016) (to be codified at 21 C.F.R. pt. 15). At the time of the writing of this paper, the hearing transcript was unavailable.

133 Id.

134 Amarin, 119 F. Supp. 3d at 228.

135 Duchesnay Warning Letter, supra note 67.

136 See Promotional Material associated with Duchesnay Warning Letter (2015) [hereinafter Promotional Material], http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457965.pdf.

137 All information was taken on October 28, 2016 from the front page of each of her public social media profiles on the respective websites.

138 Promotional Material, supra note 136.

139 See image located in David Lennarz, FDA Issues Warning Letter Due to Celebrity Endorsement, Registrar Corp. (Aug. 13, 2015), http://fda-news.registrarcorp.com/2015/08/fda-warning-celebrity-endorsement/ [https://perma.cc/N8TX-3RPZ].

140 See flawlessfashionstore, Comment to kimkardashian, Instagram, http://fda-news.registrarcorp.com/wp-content/uploads/2015/08/Kardashian-Diclegis.jpg [https://perma.cc/79TU-UH9V].

141 Ashlee Kieler, After FDA Warning, Kim Kardashian Posts Corrected Endorsement of Morning Sickness, Consumerist (Aug. 31, 2015), https://consumerist.com/2015/08/31/after-fda-warning-kimkardashian-posts-corrected-endorsement-of-morning-sickness-pill/ [https://perma.cc/3UXD-GP67]. See also supra note 71 and accompanying text.

142 Kieler, supra note 141.

143 See, e.g., supra notes 94-95 and accompanying text (describing restrictions on use of social media platforms with character limitations for drug promotional purposes).

144 Warning Letter from FDA to AMARC Enterprises, Inc., FDA, (Dec. 11, 2012), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm340266.htm [https://perma.cc/LSH7-H2E3].

145 Id.

146 See Warning Letter from FDA to AMARC Enterprises, Inc., supra note 144.

147 See supra notes 21-24 and accompanying text.

148 Roche was the only company to spend more on R&D. Ana Swanson, Big Pharmaceutical Companies are Spending Far More on Marketing than on Research, Wash. Post (Feb. 11, 2015), https://www.washingtonpost.com/news/wonk/wp/2015/02/11/big-pharmaceutical-companies-are-spending-far-more-on-marketing-than-research/?utm_term=.8302f15cbb2c [https://perma.cc/T22X-7K6G].

149 American Medical Association, AMA Calls for Ban on DTC Ads of Prescription Drugs and Medical Devices, Am. Med. Ass’n (Nov. 17, 2015), https://www.ama-assn.org/content/ama-calls-ban-direct-consumer-advertising-prescription-drugs-and-medical-devices [https://perma.cc/DJX5-KJ6F].

150 On average, generic drugs are 80-85% less costly than brand name drugs. FDA, Facts About Generic Drugs, (last updated June 28, 2016), http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm [https://perma.cc/J9JA-BYRX].

151 Chris Elkins, Celebrities Team with Big Pharma to Promote Drugs, Disease Awareness, Drug Watch (Nov. 9, 2015), https://www.drugwatch.com/2015/11/09/celebrity-and-big-pharma-drug-promotion/ [https://perma.cc/3ZY3-ADSZ]. Couric’s husband died of colon cancer, sparking her interest in increasing awareness of the disease.

152 Id.

153 Cram, Peter et al., The Impact of a Celebrity Promotional Campaign on the Use of Colon Cancer Screening: The Katie Couric Effect, 163 Arch Intern. Med. 1601, 1603-04 (2003)CrossRefGoogle ScholarPubMed.

154 Id. at 1601, 1604.

155 Anita Elberse, Risks and Rewards of Celebrity Endorsements, CNN (Dec. 16, 2009), http://www.cnn.com/2009/OPINION/12/16/elberse.athlete.endorsements.tiger.wods/ [https://perma.cc/B9EV-EV3H].

156 Marian Wang, For Years, Drug Company Paid Top Athletes to Attract Doctors, ProPublica (Nov. 19, 2010), https://www.propublica.org/blog/item/for-years-drug-company-paid-top-athletes-to-attract-doctors [https://perma.cc/A65G-QH3D] (athletes were paid between $8,000 and $35,000 per appearance).