FDA’s Draft Guidance – Exploring the impact on compliance and operations


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This session, "FDA's Draft Guidance - Exploring the impact on compliance and operations" was presented at the 10th Annual Pharmaceutical Compliance Congress, hosted by CBI.

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FDA’s Draft Guidance – Exploring the impact on compliance and operations

  1. 1. FDA’s Draft Guidance on Off-Label Marketing:Impacts for Social Media Workshop C January 29, 2013
  2. 2. Agenda• Introduction• FDA’s Draft Guidance: Background & Key Takeaways• Industry’s Response: Benchmarks• Internet Monitoring• Pfizer: Examples from Actual Experience• Q&A 1
  3. 3. FDA’s Draft Guidance on Off-Label Marketing: Impacts for Social Media FDA’s Draft Guidance:Background & Key Takeaways
  4. 4. Background• In November 2009, the FDA held a public meeting on addressing new media in life sciences marketing. o The new guidelines were narrowly focused to responding to off-label requests, and they had limited applicability.• The FDA acknowledged the importance of emerging electronic media, but the new guidance not a comprehensive policy on its use. Instead, the policy provided companies with a set of general guidelines regarding: o Unsolicited Requests: initiated by a person independent of the relevant firm (HCPs, HCOs, patients). o Non-Public Unsolicited Requests: directed privately to the firm via one-on-one communication. o Public Unsolicited Requests: via public forum directed to the firm or larger forum. o Solicited Requests: prompted in any way by a manufacturer or its representatives. 3
  5. 5. Key TakeawaysTakeaway #1: Requests For InformationRequests for information must be unsolicited.• Requests for off-label information that are prompted by a manufacturer or its representatives are considered to be solicited requests.• The following are specific examples of solicited requests: o When a representative of a company , such as a medical science liaison or a paid speaker, presents on the off-label uses of a product at a promotional event and attendees subsequently submit requests for information. o A firm encourages users to post videos on personal uses of its product on a third party website (such as YouTube) and an individual requests information based on this information. o A firm releases the results of a study on a blogging site (such as twitter) and suggests that an off- label use of the product is effective and safe. 4
  6. 6. Key Takeaways Takeaway # 2: Responding To RequestsResponses should be handled discreetly.• Requests for off-label information, whether sent publically (via website) or privately (via e-mail), should be triaged privately by the company via one-on-one communication.• Details of the communication should be documented, saved, and achieved for records retention purposes. Records of the request should include (but are not limited to): o Identifying characteristics of the requestor such as the name, address, and affiliation of the requestor o Documentation of the information provided to the requestor o Follow-up questions or further inquiry from the requestor 5
  7. 7. Key TakeawaysTakeaway # 3: Characteristics of ResponsesIt is important that responses are accurate, truthful, tailored, and not misleading:• Responses should be produced by medical sciences liaisons (MSLs), who have been trained on how to tailor responses. Responses should not be generated by sales or marketing representatives.• Responses should be clear, concise, and tailored to specifically and accurately address the question asked.Responses to Requests should contain the following information:• An obvious reference to the request being off-label stating that the FDA has not approved the product as a safe and effective means for the uses addressed in provided answers• A clear reference to the indications for which the FDA has approved the product for safe and effective use• A link to the URL describing the product’s label information• Contact Information for the Medical Affairs department• Disclosure of the responders affiliation within the company 6
  8. 8. Key Takeaways Takeaway # 4: Nature of RequestsResponses can only be given to requests that are specific to a company’s product.• Responses are only acceptable if the original request details a specific named product in the company.• Questions related to a competitor’s product cannot be answered. o Acceptable Request : “Can xxx drug be used to lower blood pressure?” o Unacceptable Request: “What drugs can be used to lower blood pressure?” 7
  9. 9. FDA’s Draft Guidance on Off-Label Marketing: Impacts for Social MediaIndustry’s Response: Benchmarks
  10. 10. Industry’s Response Monitoring Social Media Sites• Educate employees on social media, and what the Company’s social media objectives, metrics, and policies are.• Develop policies for Social Media engagements (i.e.: How will the Company triage unsolicited requests, negative information, or adverse event reports?) o Create “what if” scenarios for discussion with legal and compliance• Develop clear guidelines for responses, adverse event reporting, and employee conduct on company sponsored and non-sponsored sites.• Limit or prohibit off-label communications via any social media: o Monitor medical content on sponsored or supported web sites o Ensure that Legal and Regulatory teams review and approve all content that is placed on company sponsored or supported sites 9
  11. 11. Industry’s Response Conduct Research and Review of Current Best Practices• Though no strict laws currently exist, companies can be proactive about Social Media Monitoring practices by:• Researching libraries of past campaigns that are FDA compliant. o Examples can be found at: www.doseofdigital.com/healthcare-pharma-social-media.• Reviewing recent FDA warning letters available on www.fda.gov and participating in regular FDA-hosted online reviews of enforcement actions. 10
  12. 12. FDA’s Draft Guidance on Off-Label Marketing:Impacts for Social Media Internet Monitoring
  13. 13. Internet MonitoringProcess: Discovery & Analyzing• Subject Matter Experts and Internet Intelligence Experts can be leveraged to help facilitate the monitoring process.• Internet Monitoring has two basic processes: o Discovery: the process of identifying/finding content on the Internet o Analyzing: the process of obtaining content from a predefined source and identifying significance.• Once content has been ‘discovered,” it can then be ‘analyzed’ if necessary.• Advanced image tracking can be used to ‘discover’ Internet based content relating to branded products.• Cached content can then be de-compartmentalized by the use of categorizing filters, clustering engines and analytic tools. 12
  14. 14. Social MediaSEC focus on Social Media use• The SEC’s focus on social media has revolved around: o Retention of Social Media documents, comments, etc. o Company policies and procedures concerning the use of Social Media o Third party use of Social Media and how it relates to a firm o Supervision of employees’ personal use of Social Media o Disciplinary actions for inappropriate use of Social Media• Everyone acting on behalf of the company is held to the same standards as the company and the company will be held responsible, even if the agent fails to conform to company policies.• Social media should be treated as any other marketing channel: Ensure that the firm’s Web site provides a rich user experience, is fully functional across a variety of browsers, loads quickly, includes a ‘Share’ functionality, and is optimized for mobile devices. 13
  15. 15. Challenges of Internet Monitoring• Consumers are increasingly using the Web to search for medical information; therefore companies have to adapt to handle new forums for requests and how best to triage these requests.• Questions asked in a third-party forum might not necessarily be directed at the company (traditional requests are specifically directed at the company).• Posting an online response to an off-label question publically disseminates information to everyone (i.e. persons who have not requested it).• Permanent nature of digital content can render responses outdated especially if new risk information becomes available. 14
  16. 16. Challenges of Internet MonitoringConsiderations• Promotional Review Process – companies must consider how, when, and what to review o Developing or modifying existing policies around social media (i.e., guidelines, training) o Insuring application of FDA rules to social media o Insuring that safety information travels with efficacy claims o FDA Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion (May 2009) o Recent Warning Letters• Submission of social media materials under Form 2253 o What is the date of first use? o Application to user-generated content? 15
  17. 17. Challenges of Internet MonitoringThe How, What, and Who of Monitoring• How will the Company monitor for adverse events, off-label issues, and risk management issues (i.e., abuse of product)? o Will this apply to branded and unbranded sites, as well as sponsored and third-party sites? o Who is responsible for this process? o Resources Impacts – time, effort, personnel, vendors o Training on AE reporting- are the 4 criteria met to trigger reporting? (patient identifiable, reporter identifiable, specific drug involved, AE or fatal outcome)• What is in scope for the monitoring program? o Will there be 24/7 monitoring of branded and unbranded sites where product is mentioned (blogs, chatrooms, etc.)?• Who is using this media? Is there use by: o Company personnel- communicating with “friends” or “fans” o Company Vendors 16
  18. 18. FDA’s Draft Guidance on Off-Label Marketing:Impacts for Social MediaFocus on Social Media
  19. 19. A Brief History of the Internet, Social Media,and the FDA• 1994: Netscape launches its first web-browser• 1995: Yahoo! is founded• 1996: Google is foundedFDA holds a public hearing on Internet use by life sciences and healthcare companies• 1997: America Online launches instant messaging (AIM)• 2001: Wikipedia launches• 2003: Myspace is founded Note: Product names, logos, brands, and other• 2004: Facebook launches (first Harvard-only) trademarks featured or referred to within this• 2005: YouTube launches presentation are the property of their respective trademark holders• 2006: Facebook is opened to all users over 13 with an email address• 2006: Twitter launches (140 character tweets)• 2007: iPhone debuts• 2008: Facebook exceeds 100 million usersFDA issues warning letter re: YouTube video• 2009: FDA issues 14 untitled letters re: sponsored linksFDA holds a 2-day public hearing on promotion of FDA-regulated medical products using the Internet andsocial media• 2010: FDA issues untitled letter re: Facebook share widget• 2011: FDA issues draft guidance on unsolicited request. 18
  20. 20. 2009 Public Meeting and Docket• 2-day public hearing on promotion of FDA-regulated medical products using the Internet and social media• Focused on five questions: 1. For what online communications are manufacturers accountable? 2. How can manufacturers fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) when using Internet and social media tools that have space limitations or allow for real-time communications (e.g., microblogs, mobile technology)? 3. What parameters should apply to the posting of corrective information on websites controlled by third parties? 4. When is the use of links appropriate? 5. How should the collection and processing of adverse event reporting on the Internet be handled by manufacturers? 19
  21. 21. Letter re: Facebook Share Widget* * Product names, logos, brands, and other trademarks featured or referred to within this presentation are the property of their respective trademark holders. 20
  22. 22. Letter re: Facebook Share Widget* * Product names, logos, brands, and other trademarks featured or referred to within this presentation are the property of their respective trademark holders. 21
  23. 23. Responding to Unsolicited Requests AboutPrescription Drugs and Medical Devices• “This draft guidance is the first of multiple draft guidances the Agency plans to publish that address questions and issues relating to emerging electronic media.”• “This draft guidance updates and clarifies FDA’s policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.”• What is an “unsolicited request?” o Initiated by people/entities that are completely independent of the relevant firm o Not prompted in “any way” by a manufacturer or its representatives 22
  24. 24. Draft Guidance ContinuedWhat Is A “Solicited Request?” • Videos posted on YouTube in response to manufacturer encouraging users to share their stories about their uses of the drug, which may result in video postings about an off-label use of its products: “If the firm’s initial request for posting of videos results in any question about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the products’ off-label use, these questions would be considered solicited requests.” • A firm sends out information to bloggers or online consumer reviewers and encourages them to write about an off-label use and this then prompts a discussion about that off-label use, any requests inquiring about that off-label use as a result of these blogs would be considered solicited. • Comments and requests received in response to a tweet announcing study results suggesting that an off-label use is safe and effective. 23
  25. 25. Draft Guidance ContinuedWhat Is A “Solicited Request?” • Requests resulting from website that enables users to read prepared standard responses using prefixed pull-down menus, including any standard response related to off-label uses. “Moreover, if this website makes it possible to use search terms to generate standard responses that go beyond the scope of the product information being requested, including off-label information, resulting requests for and responses to such a search would be considered solicited requests.”“[S]olicited requests may be considered evidence of a firm’s intent that a drug or medicaldevice be used for a use other than that specifically approved or cleared by FDA.” 24
  26. 26. FDA’s Draft Guidance on Off-Label Marketing:Impacts for Social Media Q&A
  27. 27. Contact Information• Mark DeWyngaert, Managing Director at Huron Consulting Group Email: mdewyngaert@huronconsultinggroup.com Phone: (o): 646-277-8817; (c): 203-253-6203• Bernard D’Avella, Manager at Huron Consulting Group Email: bdavella@huronconsultinggroup.com Phone: (o): 646-520-0133; (c): 973-309-2426• Kelly Falconer Goldberg, Senior Corporate Counsel at Pfizer Email: kelly.f.goldberg@pfizer.com Phone: (o): 212-733-4330 26
  28. 28. FDA’s Draft Guidance on Off-Label Marketing:Impacts for Social Media Appendix
  29. 29. Draft Guidance ContinuedWhat Is A “Solicited Request?”• Irrespective of whether the request is public or private, the substantive response should be in a private, one-on-one communication• Response should be tailored to the question asked• Response should be truthful, non-misleading, accurate, and balanced• Response should be scientific in nature• Response should be generated by medical/scientific personnel, independent from sales/marketing• Response should be accompanied by: o Copy of the FDA-approved labeling o A prominent statement that FDA has not approved the product as safe/effective for the use discussed o A prominent statement of the approved indication o Important safety information o Complete list of references 28
  30. 30. Draft Guidance ContinuedPublic Unsolicited Requests• A firm should respond only when the request specifically pertains to its own named product• The public response should be limited to providing the firm’s contact information and should not include any off-label information o Convey that the question pertains to an unapproved use and state that the individual can contact the company for more information o Provide specific contact information for the individual to follow-up• If the individual follows-up, response should follow the rules above• Response should disclose that the author is affiliated with the firm• Public response should not be promotional in nature/tone o Should include a direct link to the FDA-approved labeling o Should not include links to any other information (product websites, firm websites, third- party websites) 29