Digitas Health Online Sharing: What Pharma CAN Do
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Digitas Health Online Sharing: What Pharma CAN Do

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FDA‟s recent enforcement action citing Novartis for inappropriate use of the Facebook® Share feature on its Tasigna (nilotinib) website (www.us.tasigna.com) provided welcome clarification on some ...

FDA‟s recent enforcement action citing Novartis for inappropriate use of the Facebook® Share feature on its Tasigna (nilotinib) website (www.us.tasigna.com) provided welcome clarification on some issues surrounding the use of social media by pharmaceutical companies — and reinforced Digitas Health‟s view that it is entirely practicable for pharmaceutical companies to enable sharing on their websites to help advance the public health by making information about the safe and effective use of prescription medications available to a wider audience.
This analysis examines some of the most popular sharing technologies — including URL shorteners — and provides specific recommendations on how they can be used compliantly.

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Digitas Health Online Sharing: What Pharma CAN Do Digitas Health Online Sharing: What Pharma CAN Do Document Transcript

  • Digitas Health POV Online Sharing: What Pharma CAN Do UPDATED: August 17, 2010 Analysts: Dale Cooke, VP/Director, Regulatory Review Chris Everly, Director, Search Engine Optimization EXECUTIVE SUMMARY FDA‟s recent enforcement action citing Novartis for inappropriate use of the Facebook® Share feature on its Tasigna (nilotinib) website (www.us.tasigna.com) provided welcome clarification on some issues surrounding the use of social media by pharmaceutical companies — and reinforced Digitas Health‟s view that it is entirely practicable for pharmaceutical companies to enable sharing on their websites to help advance the public health by making information about the safe and effective use of prescription medications available to a wider audience. This analysis examines some of the most popular sharing technologies — including URL shorteners — and provides specific recommendations on how they can be used compliantly. BACKGROUND On August 3, 2010, FDA‟s Division of Drug Marketing Advertising and Communications (DDMAC) posted to the FDA website an untitled letter that had been sent to Novartis Pharmaceuticals on July 29, 2010, regarding its use of the Facebook Share tool on the US website for Tasigna (nilotinib) (www.us.tasigna.com).1 Based on the promotional materials posted with the letter, it appears that the Tasigna website featured a button that enabled users to “share” on their personal Facebook page an image, a description of a webpage, the webpage title, and a link to the webpage — all content created by Novartis. When a webpage link is shared via Facebook Share, the content that is used for the link is pulled in various ways. By default, Facebook will pull the browser bar title tag as the title of the shared content. Facebook will also pull the description from the metadata description tag. However, the site owner has the option of including coding to instruct Facebook to pull instead from a custom title and description, independent of the browser bar title and metadata description. The Essential Feature of a Social Media Sharing Tool The central functionality shared by all social media sharing tools is that they enable users to broadcast content to others in their “social graph” (followers). This can be done either via posting the content to a location (such as a Facebook Wall or Delicious.com page) that followers monitor or by sending out the content to users via email, text message, etc. RELEVANT FACTS FDA enforcement letters provide a detailed description of the facts related to the promotional material and its use in addition to the description of the infractions. The Division of Drug Marketing Advertising and Communications (DDMAC) takes great care to explain which features of a communication incurred the violation. Careful reading of these letters also reveals exactly which aspects of a communication did NOT incur violations, and therefore, could be inferred, as permissible. 100 East Penn Square | Philadelphia, PA 19107 © 2010 Digitas Health phone (215) 545-4444 | fax (215) 545-4440 | digitashealth.com
  • In the case of the use of Facebook Share, DDMAC explicitly noted the following features of the “widget”2: 1. “Clicking on the widget takes users to a separate webpage with Novartis-created content about Tasigna.” 2. “Users may add additional comments, which are displayed separately” 3. “[U]sers cannot edit the original text, URL or graphics for Tasigna created by Novartis”3 4. “Clicking on the „share‟ option allows users to post the shared content for Tasigna on their Facebook profile walls and to share this same information with other Facebook users” 5. “The shared content … may also be sent separately as a message” At no point does DDMAC assert that any of these features, per se, constitute a violation.4 Historically, if DDMAC had found any of these features inherently violative, then this letter would have been the vehicle to indicate that view and provide the relevant statutory or regulatory basis for the violation. Instead, DDMAC used this description of the functionality of the Facebook Share feature to provide background for noting that the message communicated in this manner — not the medium — was inappropriate. Pharmaceutical marketers and regulatory professionals who may have previously harbored doubts about the regulatory status of sharing functionality should breathe somewhat easier following this enforcement action, which largely dispels any dubious tinge that may have hovered over this basic social-media functionality. THE VIOLATIONS At the same time, DDMAC‟s letter to Novartis clearly drew a bright line around the kinds of messages that can be communicated via this functionality. In particular, DDMAC held that: 1. Messages must provide risk information (though exactly how much is not defined) at the same time and in the same manner as the benefit information.5 The so-called “one-click rule,” (which never, in fact, existed) seems truly to be dead.6 2. Presentation of indication must be accurate and complete, regardless of space limitations. 3. When pharmaceutical companies make material available for sharing, the information made available for sharing must be submitted to FDA under cover of Form 2253.7 DDMAC found Novartis in violation for failure to comply with these long-established principles.8 ADDITIONAL APPLICABLE CONSTRAINTS In addition to the action taken by DDMAC in the July 29, 2010, letter to Novartis, DDMAC has previously enunciated several principles that apply to social media communications. Use of Brand Name DDMAC has noted on several occasions that the presence of the brand name in a URL constitutes a mention of the drug.9 Consequently, any social media tool that shares the full URL for a Brand.com website will require the presence of the generic product name. Black-Box Drugs Drugs featuring so-called “boxed” warnings (21 CFR 201.100(f) and 202.1(e)(2)(i)) are prohibited from engaging in reminder advertising. Reminder ads, by definition, include the name of the drug (including both brand name and generic) but nothing that provides additional information about the drug or its use. August 17, 2010 Online Sharing: What Pharma CAN Do Page 2 of 6
  • FITTING COMPLIANT MESSAGES INTO SPACE-CONSTRAINED SOCIAL MEDIA FORMATS Most social media sharing tools set limits on the amount of content that is shared, effectively making it impossible to provide a full product-promotion message, which must include: 1. The brand and generic name of the drug 2. The complete indication 3. Risk information sufficient to meet the fair balance requirement 4. Adequate provision of the full prescribing information For example, Facebook‟s Share function displays up to 100 characters of a webpage‟s title and 121 characters of text from the page‟s metadata description (or copy on the webpage if no metadata description is provided).10 To put these limitations in context, Tasigna‟s brand and generic name have 19 characters, and the first indication alone in Tasigna‟s current PI has 390 characters11 — nearly twice as many characters, by themselves (i.e., without considering what degree of risk information would be considered “material” and therefore mandatory) as the Facebook Share feature permits. As noted in our previous communication about this enforcement action12, when it is not possible to present a full product-promotion communication, there remain two options for pharma marketers: 1. Reminder Messages A reminder ad is defined in 21 CFR 201.100(f), and 202.1(e)(2)(i) as an ad (or related promotional item) “which calls attention to the name of the drug product but does not include indications or dosage recommendations…” Such advertisements “shall contain only the proprietary name of the drug product, if any [and] the established [i.e., generic] name of the drug product …” Importantly, both 21 CFR 201.100(f) and 202.1(e)(2)(i) note that “[r]eminder labeling…is not permitted for a prescription drug product whose labeling contains a boxed warning….” Nothing in the letter for Tasigna (which is a black-box drug) indicates that DDMAC intends to create an exemption for black-box drugs to make use of reminder advertising via sharing functionality. Also as noted above, DDMAC has clearly indicated that the inclusion of the brand name in the URL (but nowhere else) constitutes a mention of the drug that requires inclusion of the generic name. This requirement applies to reminder advertising as well as standard product promotions. 2. “Help-Seeking” Messages The other alternative to a full product-promotion message is to omit the name or any definite description of a drug. As defined on DDMAC‟s website, “Help-seeking ads describe a disease or condition but do not recommend or suggest a specific drug treatment.” 13 Any mention, either explicitly or implicitly, of a specific product in what is intended to be a help-seeking communication converts that communication into a product-specific promotion, and DDMAC has repeatedly made it clear that such communications require risk information.14 August 17, 2010 Online Sharing: What Pharma CAN Do Page 3 of 6
  • URL Shorteners With the proliferation of sharing — especially the sharing of website links via text message and other space- constrained vehicles — a new category of service has emerged. Called URL shorteners, these services (e.g., TinyURL, bit.ly, and Twurl) append a short, random string of characters to a brief root URL. That new URL when pasted into a web browser‟s address bar or clicked on re-directs users to the original URL.15 For example, bit.ly converts the Scribd.com page for one of the authors of this POV from http://www.scribd.com/dale_cooke to http://bit.ly/9skHKH The saving in character count depends on the original URL‟s length. That savings is in itself significant in the context of social media sharing. In addition though, and more germane to the focus of this POV, the process of converting a URL obscures any information about a brand from the original URL in the resulting random string of characters. Applying such technology to a shared message would convert the following, violative communication: This website has valuable information about treatments for Disease X http://www.Brand.com/CureForDiseaseX (105 characters)16 to the non-violative: This website has valuable information about treatments for Disease X http://bit.ly/9skHKH (89 characters) The converted message seems to qualify as a help-seeking advertisement, and help-seeking advertisements do NOT require the provision of risk information for a drug because no drug is mentioned. The chart below summarizes the information-sharing parameters for the most popular social platforms.17 Content Pulled Can the pulled Can the pulled Automatically Can Use URL content be content be edited Uses URL Page Metadata Shortening? controlled by by the user before URL Shortening? Title Description pharma? posting? Facebook X X X No Yes Yes Yes18 Delicious X X No Yes Yes Yes Digg X X X No Yes Yes Yes Twitter X X Yes* Yes Yes Yes * Refers to new “official” Tweet button from Twitter. Note that while all of these sharing tools offer the option of using URL shorteners, only some do so automatically. August 17, 2010 Online Sharing: What Pharma CAN Do Page 4 of 6
  • RECOMMENDATIONS 1. Pharmaceutical marketers who choose to implement sharing functionality for drugs with boxed warnings should ensure that they make use of the URL shortener to remain compliant. 2. For drugs that do not feature a boxed warning, companies should ensure that they either comply with the reminder-advertising requirements or use a URL shortener in conjunction with a help-seeking message. These recommendations are summarized in the following chart: Reminder Message Help-Seeking Message Using a URL No URL Using a URL No URL Shortener Shortener Shortener Shortener Not Not Not Black-box Drugs PERMISSIBLE Permissible Permissible Permissible Non-Black-box Not PERMISSIBLE PERMISSIBLE PERMISSIBLE Drugs Permissible Disclaimers This report is a publication of Digitas Health and is intended to provide information on recent FDA developments. This report should not be construed as legal advice or an opinion on specific situations. REFERENCES 1. The letter to Novartis was accessed on August 4, 2010 from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPhar maceuticalCompanies/ucm197224.htm 2. MACMIS #18870, page 2. 3. The FDA asserts this in the letter to Novartis, but in extensive testing and examination by experts on Facebook APIs, Digitas Health has NOT been able to find any way to prevent the content from being edited. Digitas Health believes that the sharing feature as implemented on Tasigna‟s website did permit users to edit the shared content. The ability to edit the content pulled from a webpage is not obvious because there is no instruction telling users that they can do so, but it is nonetheless available. 4. Since the FDA ignored all content generated by users as comments and limited its enforcement action to the content that Novartis generated, in the analysis that follows, Digitas Health assumes that DDMAC's primary consideration was whether the pharmaceutical company was responsible for the content. In our opinion, in the eyes of the FDA, a pharmaceutical company is responsible for all the content it creates but only the content it creates regardless of whether that content is later modified. 5. See Digitas Health Regulatory Alert: FDA‟s First Facebook Enforcement Action, published August 5, 2010. Last accessed August 10, 2010 from http://www.scribd.com/doc/35466006/Digitas-Health-Facebook-Regulatory-Alert-20100805 6. Mary Sullivan, Director, Advertising and Promotion, Drug Regulatory Affairs with Boehringer Ingelheim delivered a presentation at the Social Media Tools conference on June 22, 2010, that suggested an origin of the urban myth that providing risk information one click away from the benefit information sufficed to meet the fair balance requirement. She found a citation in Docket No. 2003 N-0344 submitted in response to Request for Comments: Consumer-Directed Promotion by Federal Trade Commission that suggested something very similar to the one-click rule. Regardless of its origins, the “one-click rule” was never a rule, and FDA has consistently maintained in numerous enforcement actions going back at least to the letter sent to Novartis Pharmaceuticals for Internet banner ads promoting Diovan (valsartan) Tablets, dated August 28, 2008, MACMIS ID # 16734 that risk information must be presented in the same place as the benefit information, and that the fair balance requirement is not met by providing risk information one click away from the benefit information. 7. In the case of subpart H products, such as Tasigna, materials must also be submitted 30 days prior to use. 8. Note that there was an additional violation, but that violation was agnostic of media. Consequently, we ignore it in this discussion. For a more thorough discussion, see Digitas Health Regulatory Alert: FDA‟s First Facebook Enforcement Action, published August 5, 2010. Last accessed August 10, 2010 from http://www.scribd.com/doc/35466006/Digitas-Health-Facebook-Regulatory-Alert-20100805 9. See, for example, the March 26, 2009, letters sent to Merck & Co. for Januvia (sitagliptin) MACMIS# 17312; Bayer for Levitra (vardenafil HCl) MACMIS# 17307; Boehringer Ingelheim for Flomax (tamsulosin hydrochloride) MACMIS# 17308; Biogen Idec for TYSABRI (natalizumab) MACMIS# 17314; Genentech August 17, 2010 Online Sharing: What Pharma CAN Do Page 5 of 6
  • for Xolair (Omalizumab) MACMIS# 17309; GlaxoSmithKline for Avodart (dutasteride) MACMIS# 17317; Johnson & Johnson for Prezista (darunavir ) MACMIS# 17310; Novartis for Femara (letrozole tablets) MACMIS# 17313. Last accessed June 18, 2010, from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPhar maceuticalCompanies/ucm055773.htm 10. For the character limits used by Facebook‟s Share feature, see http://www.whoisgregg.com/blog/2009/05/optimizing-for-facebook-share- preview.html Accessed August 5, 2010. 11. Prescribing Information, Tasigna (nolitinib), Novartis Pharma Stein AG, Revised June 2010. 12. See Digitas Health Regulatory Alert: FDA‟s First Facebook Enforcement Action, published August 5, 2010. Last accessed August 10, 2010 from http://www.scribd.com/doc/35466006/Digitas-Health-Facebook-Regulatory-Alert-20100805 13. From FDA‟s website: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072077.htm#help_seeking, accessed on June 9, 2009. 14. See Digitas Health Regulatory Alert: Unbranded Promotions Targeted by FDA Enforcement Actions, published May 5, 2010. Last accessed August 10, 2010 from http://www.scribd.com/doc/34283554/Regulatory-Alert-Unbranded-Enforcement-Digitas-Health-May-2010 15. For additional information about URL shorteners, see http://en.wikipedia.org/wiki/URL_shortening Last accessed August 10, 2010. While the following discussion focuses exclusively on URL shorteners because of their prominence in social media, URL shorteners are only one method of implementing a URL re-direct. Only one DDMAC enforcement action has addressed the use of URL re-directs, and that enforcement action appears to validate the use of re-directs in general because the use of the re-direct was mentioned but was NOT indicated by DDMAC to be a violation. See the letter sent on April 15, 2010, to GlaxSmithKline for Arzerra™ (ofatumumab) Injection, for intravenous infusion MACMIS# 18191. Last accessed April 21, 2010 from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPha rmaceuticalCompanies/ucm197224.htm 16. This would be violative because it includes the brand name (in the full URL) and information about the disease without full indication and without any risk information. 17. In determining which sharing services to review, Digitas Health took into consideration the most popular services according to one of the most prominent sharing aggregating tools. See http://addthis.com/services Last accessed on August 11, 2010. Note that MySpace was omitted from this review because recent usage has declined dramatically, and its demographics do not appear to be as relevant to pharmaceutical marketers. See http://www.quantcast.com/myspace.com for additional information about MySpace's demographics. Last accessed on August 11, 2010. 18. Note again that according to the FDA's enforcement action, it is NOT possible to edit the content pulled via Facebook Share, but Digitas Health has been unable to recreate that. August 17, 2010 Online Sharing: What Pharma CAN Do Page 6 of 6