From Social Media to Soap Operas Exploring New and Novel Advertising and Promotion Tactics

Transcription

1 OFF-LABEL COMMUNICATION CONFERENCE February 28, 2018 From Social Media to Soap Operas Exploring New and Novel Advertising and Promotion Tactics Heather Bañuelos Counsel King & Spalding Gillian M. Russell Counsel King & Spalding

2 Presenters Heather Bañuelos Gillian M. Russell

3 Agenda Recent Developments in Advertising and Promotion FDA and FTC Drugs and devices Novel Marketing Practices 3

4 Current Landscape: Core Areas of Focus DTC False/ Misleading Off- Label Risk Disclosure Pre- Approval Transparency 4

5 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION OFF-LABEL 5

6 OPDP Enforcement: Grinding to a Halt Number of OPDP Enforcement Letters, * *As of 2/25/2018 6

7 Device Ad/Promo Enforcement Letters, January 2012 December

8 Enforcement Letters by Issuing Entity CDRH ORA (Districts/Divisions ) CBER

9 Medical Device Enforcement Letters Common Topics, New intended use General vs. specific indication Unapproved combination use Comparative or clinical claims Unapproved new device Limits of 510(k) exemption exceeded Omission or minimization of risk information Inadequate support for claims Claim of FDA approval for 510(k)-cleared or 510(k)- exempt device Significant Instructions for Use (IFU) or labeling changes 9

10 Device Promotion that Garnered FDA Attention in 2017 Newsworthy topics Zika Virus Health-Chem Diagnostics, LLC (December 7, 2017) Blood lead levels Magellan Diagnostics, Inc. (October 23, 2017) Concussions Dynavision International, LLC (September 5, 2017) SyncThink, Inc. (July 31, 2017) High-risk applications Targeting of radiation therapy QLRAD Netherlands/Hospimed (July 20, 2017) HIV testing (May 18, 2017) Ignoring/Refusing the Agency Pelvic Therapies, Inc. (October 17, 2017) 10

11 2017: First Amendment Activities Memo Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products Draft Guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Questions and Answers Draft Guidance Medical Product Communications That Are Consistent With the FDA- Required Labeling Questions and Answers Regulation Intended Use 11

12 First Amendment Memorandum November 9-10, 2016 Public Hearing Obtain comments on FDA s regulation of... firms communications about unapproved uses of their approved/cleared medical products Memorandum of First Amendment interests and alternatives Designed to address the test for commercial speech restrictions under Central Hudson 12 alternatives considered and rejected by FDA 3 Appendices re FDA authority and harmful offlabel uses 12

13 Expanded Communication Pathways Are Not Off-Label Publications Reprints: Off-Label and Risk Information Communications with Payors - Investigational Medical/Scientific Conference Presentations Responding to Unsolicited Requests HCEI Communications with Payors Support for Independent Scientific/ Educational Activities ClinicalTrials.gov Consistent with Label Communications 13

14 Intended Use Fundamental to FDA s regulation of drugs and medical devices The intended use of a product is the primary basis for determining whether and how a product is regulated by FDA FDA intended use regulations 21 C.F.R (drugs) and (devices) Amended and recently 2015 Proposed Rule (80 Fed. Reg (Sept. 25, 2015)) 2017 Final Rule (82 Fed. Reg (Jan )) Effective date delayed twice, with last effective date March 19, 2018 As of January 2018, effective date is delayed indefinitely (83 Fed. Reg (Jan. 16, 2018)) 14

15 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION DIRECT TO CONSUMER 15

16 SUPER: Weight loss may cause low blood sugar Stop taking CONTRAVE and call a doctor right away if you experience any of these AVO: Other serious side effects include... SUPER: Nausea, constipation, headache, and vomiting occurred in >10% of patients AVO: Do not take with opioids CONTRAVE Untitled Letter (May 2017) 16

17 DTC TV Ad Scrutiny Continues - Examples from

18 OPDP Research: Significant DTC Focus Eye Tracking Study of DTC Prescription Drug Advertisement Viewing Eye tracking technology was used to determine how DTC ads are perceived and to measure impact of distraction References FTC s clear and conspicuous standards and disclosure guidelines to minimize distraction/competing elements Results: Distracting elements during the major statement decreased attention to superimposed risk information, leading to lower retention of risk information Even if risks are presented in audio and text, distracting visuals should be avoided Sullivan HW, et al., Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye-Tracking Study. Journal of Public Policy & Marketing: Fall 2017, Vol. 36, No. 2, pp

19 Lessons Learned: Considerations for DTC TV Ads Do visuals / audio minimize the risks? Upbeat music / happy people / happy scene Are visuals distracting from the risk message? Frequency of scene changes Level of activity, movement and pace Use of supers unrelated to risk message Are visual and audio risk disclosures competing with each other? Expect increased FDA scrutiny of ads for products with serious risks 19

20 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION RISK DISCLOSURE 20

21 Risk Disclosure in DTC Ads 21

22 OPDP Research: Significant DTC Focus Disclosure Regarding Additional Risks in DTC Prescription Drug Ads (Major Statement) Limited risks plus disclosure strategy Severe (life-threatening), serious, and/or actionable risks plus Disclosure to alert consumers of existence of other product risks: This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information. Critical elements Dual modality (audio and visual) for disclosure statement Opening statement to frame risks in major statement Betts KR, et al., Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements. Research in Social and Administrative Pharmacy (2017) 22

23 Risk Disclosure in DTC Broadcast Ads 2017: FDA request for comments on modifying the requirements of the major risk statement in DTC television advertisements Major Statement: Limited risks plus disclosure strategy Severe (life-threatening), serious, or actionable Disclosure to alert consumers of existence of other product risks This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information. 23

24 Risk Disclosure in Consumer Print Ads Revised Draft Guidance February 2015 Brief summary: FDA strongly recommends against... the traditional approach Adequate directions for use: FDA also strongly recommends against providing the full PI (for consumer print promotional labeling) Consumer brief summary Alternative to the risk information in promotional labeling, brief summary in advertising, and full PI 24

25 Risk Disclosure in Consumer Print Ads Language & Readability Consumer-friendly language presented in readable format Content Most serious and most common risks Omit less pertinent information Disclosure statement Format Prescription Drug Facts Box Question & Answer 25

26 OPDP Research: Significant DTC Focus Web and Mobile Technology DTC Content Analysis Descriptive content analysis of DTC prescription drug promotion Branded promotion delivered via mobile platforms Results: persistent lack of fair balance 1 Use of quantitative information on cancer-related branded prescription drug websites Results: Majority of sites included quantitative information 2 Suggest numeric formats as best practices 1 Aikin KJ, et al., Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis. J Med Internet Res 2017;19(7):e225; 2 Sullivan, HW, et al., Quantitative Information on Oncology Prescription Drug Websites. J Canc Educ 2016; DOI /s

27 CONZIP Warning Letter (August 2017) 27

28 Lomaira Warning Letter (December 2017) 28

29 Zolpimist Warning Letter (November 2017) 29

30 Xtampza ER Untitled Letter (February 2018) 30

31 CDER 2018 Guidance Agenda Advertising Updating Promotional Materials to Reflect Labeling Changes to Risk Information 31

32 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION FALSE AND MISLEADING 32

33 Communications with Payors Health Care Economic Information Federal Food, Drug, and Cosmetic Act 502(a) New HCEI Framework Expands HCEI beyond economic analysis FDAMA st Century Cures Act 3037 Includes comparative analyses to another drug or intervention Clarifies covered audience HCEI relates to an approved indication Based on competent and reliable scientific evidence (CARSE) 33

34 Communications with Payors Guidance Health Care Economic Information HCEI Audience Relates to clinical data, inputs, clinical or other assumptions, methods, results and other components underlying or comprising the analysis Variety of formats (e.g., evidence dossier, reprint) Healthcare decision maker Consider HCEI through a deliberative process Appropriate range of knowledge and expertise in... HCEI Relates to the disease or condition, manifestation of the disease or condition, or symptoms associated with the disease or condition in the patient population for which the drug is [approved]. CARSE Generally-accepted scientific standards, appropriate for the information being conveyed, that yield accurate and reliable results. Authoritative bodies standards Context Study Design Methodology Generalizability Limitations Sensitivity Analyses FDA Approved Labeling Financial / Affiliation Bias And more.... Promotional Proactive HCEI is considered promotion Post-marketing reporting via Form FDA

35 Consistent with Label Guidance Consistent Communications Guidance Describes how FDA intends to treat information, including promotional claims, that is: Not contained in FDA-required labeling, but Consistent with FDA-required labeling Information will not alone be considered evidence of a new intended use On Label Out of Label Off Label 35

36 Consistent Communications Guidance: Three-Factor Test How does the out of label information compare to the FDA-required labeling? Indication Patient Population Limitations and Directions for Handling/Use Dosing/Administration Does the out of label information increase health risks relative to information in the FDA-required labeling? Does the FDA-required labeling enable the product to be safely used under conditions suggested by the out of label information? 36

37 Consistent Communications Guidance: Considerations and Examples Truthful and not misleading Scientifically appropriate and statistically sound Contextual information (including disclosures) is critical Comparisons Adverse Reactions Onset of Action Long-term safety/efficacy Patient Subgroups Patient- Reported Effects Convenience Mechanism of Action 37

38 CDER 2018 Guidance and Research Guidance Agenda - Advertising Presenting Quantitative Information in Direct-to- Consumer Promotional Labeling and Advertisements Research in progress Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Advertising 38

39 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION PRE-APPROVAL 39

40 Communications with Payors Guidance Pipeline Communications Safe Harbor Expressly permits pre-approval communications with payors about investigational products Includes investigational drugs and devices Excludes investigational uses of approved products No specific timing Disclosures Investigational status Stage of product development 40

41 Communications with Payors Guidance Pipeline Communications Safe Harbor Scope of Information Proposed Indication Product Information (e.g., drug class, device design) Results of Clinical and Preclinical Studies Pricing Information Anticipated Timeline for Approval/ Clearance Marketing Strategies Patient Support Programs Unbiased, factual, accurate, and nonmisleading and non-promotional 41

42 Untitled Letter to UCLA (December 2017) 42

43 Remoxy Untitled Letter (Sept. 8, 2016) 43

44 Celator Untitled Letter (August 25, 2016) 44

45 RECENT DEVELOPMENTS IN ADVERTISING & PROMOTION TRANSPARENCY 45

46 FTC Focus: Transparency in Advertising It is deceptive to mislead consumers about the commercial nature of content Cannot misleadingly suggest that content is independent, impartial, or from a source other than the sponsoring advertiser If it is an ad, it must be labeled as such Affects consumer interaction with the content and weight and credibility given 46

47 FTC Focus: Influencer Marketing Partnerships with individuals to promote or endorse a product (often through social media) Content intended to be personal and organic Celebrities, pseudo-celebrities, and everyday people or bloggers with significant followings Patient ambassadors / patient opinion leaders Healthcare opinion leaders Physician spokespeople / thought leaders 47

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50 FTC Guidance Updates: Influencer Marketing FTC s Guides Concerning the Use of Endorsements and Testimonials in Advertising (2009) FTC Dot Com Disclosures Guidance (2013) FAQs: The FTC s Endorsement Guides What People Are Asking (Updated 2017) FTC Tweet Chat on Social Media Influencers (September 2017) 50

51 FTC: When in Doubt, Disclose FTC requires disclosure of any material connection between influencer and sponsoring company Cash, in-kind payment, free product, etc. if not reasonably expected Ownership interest Family connections Sweepstakes / contest entries? Charitable donations in exchange for review? 51

52 Disclosures Must be Clear and Conspicuous Use straightforward language Clear: Sponsored, Paid ad, or promotion Vague: Thank you, Partnered, #SP, ambassador Place disclosure where it will be easily seen Platform disclosure tool may be insufficient Ensure prominence (color, font, etc.) Do not bury disclosure in a string of hashtags Disclosure should be placed at the top of the post 52

53 FTC to Crack Down on Paid Celebrity Posts That Aren t Clear Ads August 5, :00 AM EDT We ve been interested in deceptive endorsements for decades and this is a new way in which they are appearing. Michael Ostheimer Deputy, FTC Ad Practices Division If consumers don t read the words, then there is no effective disclosure. If you have seven other hashtags at the end of a tweet and it s mixed up with all these other things, it s easy for consumers to skip over that. The real test is, did consumers read it and comprehend it? e.g., #sp #spon 53

54 After reviewing numerous Instagram posts by celebrities, athletes, and other influencers, Federal Trade Commission staff recently sent out more than 90 letters reminding influencers and marketers that influencers should clearly and conspicuously disclose their relationships to brands when promoting or endorsing products through social media. 54

55 Martin, Cassell, and their company misrepresented that videos of themselves and other influencers gambling on the CSGO Lotto website and their social media posts about the website reflected the independent opinions of impartial users of the service. [I]n truth, Martin and Cassell are owners and officers of the company operating the CSGO Lotto website and the other influencers were paid to promote the website and were prohibited from impugning its reputation. 55

56 Native Advertising Advertising intended to mimic non-advertising content in style and form. Customized / organic to the site Articles, advertorials, white papers, physician webinars / interviews, videos, etc. 56

57 If paid for or written by a device or pharmaceutical manufacturer (or other entity), they would be native ads 57

58 . National retailer Lord & Taylor has agreed to settle Federal Trade Commission charges that it deceived consumers by paying for native advertisements, including a seemingly objective article in the online publication Nylon and a Nylon Instagram post, without disclosing that the posts actually were paid promotions for the company s 2015 Design Lab clothing collection. 58

59 NOVEL MARKETING PRACTICES: SOCIAL MEDIA 59

60 Facebook First on Social Media 80% 70% 60% 50% 40% 30% 20% 10% 0% Facebook YouTube LinkedIn Twitter Instagram Tumblr Source: Cutting Edge Media and Klick Wire (August 2017) 60

61 Including for Branded Content Facebook YouTube Twitter Tumblr Instagram Pinterest Source: 61

62 Facebook: Increase in Full Claim Ads Scrolling ISI Balanced Statement 62

63 Facebook: More Options for Safety Presentation Pinned ISI Links to PI and ISI 63

64 Facebook: Option to Turn off Comments Share is available, but Like and Comment are not 64

65 Facebook Comments: Considerations Resources for real-time monitoring Community Guidelines outlining comment policy Adverse Event (AE) reporting obligations Policy and training on employee social engagement Remember 2014 Zarbee s Warning Letter for Facebook Likes and Comments by the company 65

66 New Presentation Styles: Carousel 66

67 New Presentation Styles: Canvas 67

68 Facebook: Videos Posts Branded Video Unbranded 6-Second Videos Is video the new Facebook image? 68

69 Facebook: Animation / Characters 69

70 Practices Vary by Platform - Primarily corporate / PR communications - Disease awareness infographics - Less branded content than other platforms - Corporate and recruiting videos - Branded content with scrolling ISI: TV commercials, testimonials - Primarily corporate pages for talent acquisition - Increasing Pharma presence (branded and unbranded) - Innovator platforms Some Tumblr and Snapchat use for engagement with younger patient populations 70

71 OTHER NOVEL MARKETING PRACTICES 71

72 Novel Strategy: Reality TV 72

73 Novel Strategy: Soap Opera 73

74 Novel Strategy: Pop Up Shop 74

75 Novel Strategy: Pop Up Shop Source: PSFK 75

76 Novel Strategy: Detailing New Targets Source: Wave 76

77 Novel Strategy: Detailing New Targets Source: Jake Harper/ Side Effects Public Media 77

78 Telemedicine 78

79 Heather Bañuelos Counsel King & Spalding Gillian M. Russell Counsel King & Spalding QUESTIONS?