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Dii POV: FDA Off-Label Guidance


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In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.

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Dii POV: FDA Off-Label Guidance

  1. 1. Highlights FDA Guidance: Responding to The FDA has issued key requests for off-label information considerations for Carlen Lesser, Digital Integration & Innovation responding to unsolicited off- Contributors: Nina Baliga, Sara Collis, Rebecca Johnson and Lian Han label requests for drug information Summary In late December 2011, the United States Food and Drug Administration (FDA) released a guidance document addressing how In its guidance, the FDA the pharmaceutical industry can, and should, respond to requests outlines the difference made about off-label drug usage. The document, titled Guidance for between solicited and Industry Responding to Unsolicited Requests for Off-Label Information unsolicited, public and About Prescription Drugs and Medical Devices, walks readers through private requests for the appropriate responses. The guidance differentiates between information unsolicited and solicited, public and private requests; cites examples of off-label requests; and nods towards consumer and industry usage In general, the FDA warns that of social media tactics. In the FDA’s usual manner, the document is all responses must provide not concrete, is not comprehensive of all situations and marketing medical, non-promotional, mediums and is open to interpretation. However, more so than in on-label product information previous guidance documentation, here the FDA has provided more specific examples and “for instances.” The FDA emphasizes that In general, and not surprisingly, the FDA warns that all responses, private responses that in no private or public, to unsolicited or solicited requests, must provide way promote off-label use of accurate and only medically based, on-label, product information. products are the most They also stress that responses should come from medical experts, compliant way to respond to rather than sales representatives, and should be based on pre- an off-label request approved language, important safety information and prescribing information. The FDA stresses that these responses should be The document provides provided in private, rather than in a public forum. guidance-specific examples and situations that Key Information pharmaceutical companies The FDA has carefully given its official definition of “unsolicited”: can use to craft their "Unsolicited requests are those initiated by those persons or entities that are completely independent of the relevant firm."(page 4, lines response strategy 109-110). This definition is very important, as later examples in the guidance clearly show that this also means that companies must be The examples refer to Web careful to in no way invite off-label requests by means of a “share properties (both company your story” type of campaign or Web functionality. If this were to owned and 3rd party), social happen, the requests would no longer be considered unsolicited. networking and in-person requests
  2. 2. The FDA states that unsolicited requests are those prompted by an entity that is “completely independent ofthe relevant firm,” which includes pharmaceutical companies, medical groups, healthcare organizations andthe like, while solicited requests are those “prompted by the manufacturer or representative.“ A publicrequest is one made in a public forum and not necessarily directed toward the manufacturer or other medicalstaff; while a private request is one made directly to the manufacturer in a public setting.When it comes to the core issue the guidance document truly focuses on, it is fairly straight forward. Per long-standing regulation, pharmaceutical companies still may not offer up or promote off-label uses of approvedprescription products or medical devices. This new guidance does, however, provide the industry with theways in which to respond to unsolicited questions about off-label uses. Where this gets interesting is that anunsolicited request can be one that is directly sent to a pharmaceutical company or posted on a third-partypublic forum. Until now, there was no legal way for a pharma company to respond on these public forums.Public vs. PrivateThe definitions of public and private requests are fairly straightforward, but it is the manner in which pharmacompanies respond to requests that needs to be carefully considered. In all cases, companies must ensurethat their responses in no way promote off-label use of a product. The responses, regardless of whether therequest was public or private, must be private in nature and include standard response information like thepackage insert. Responses must also prominently display safety information, be scientific in nature, comefrom medical personnel, and include a complete list of references for all information (page 9, lines 300-321).A big part of the FDA’s recent guidance is an emphasis on responding to unsolicited requests through private,one-on-one channels (page 7, lines 237-238). In an age when websites and social media platforms allow forcomments and requests via usernames, abbreviations and the like, finding the contact information necessaryto facilitate private communications may prove complex for pharmaceutical companies. Many directmessaging features require one to be logged into the site, and would then require the approvedrepresentative of the pharmaceutical or medical device manufacturer to have an official account on thewebsite in question. This opens an entirely new issue around whether or not pharma companies should haveaccounts on social networking sites, or if individual representatives should create accounts used for thispurpose – an issue well beyond the scope of this document or the FDA’s guidance.In terms of the level of effort the FDA expects from pharmaceutical companies in pursuing and seeking out theinformation necessary for private communications, one can look to the FDA’s guidance in following up onadverse event comments and messages. If the requester does not provide contact information, or is not easilyaccessible through their profile, or if the platform does not permit private communications, then thepharmaceutical company cannot respond to the request per the FDA’s recent direction. This guidance appliesto unsolicited, product-specific, off-label requests that are made either through a non-public forum or publicforum and necessitate a follow-up with off-label information.Use Cases to ConsiderWhile the FDA has provided many excellent examples of applications to digital, there are some additional use-cases we believe must be considered. RTCRM Proprietary Page 2
  3. 3.  Share Your Story Campaigns: The FDA does reference issues around the “share your story” type of campaign on page 5, example 8. This example reinforces that these types of campaigns need to continue to carefully stay within approved label indications, and whatever is posted to the Internet in response to the “share your story” call-to-action is considered a “solicited request.” On-Site Search Results: On-site search is an area that the FDA did not address, and is one that we feel should be reviewed by individual companies in light of this guidance. It is clear from the guidance that companies cannot publicly post off-label information on medical information sites or any other websites. Where firms may accidentally run afoul of the guidance is in the way search may be implemented on medical information or multi-product websites. If a user includes a product name as part of an on-site search, the results should not include any content that suggests an off-label use. We believe this would be considered a solicited request, and therefore the search results are considered promotional. To avoid articles appearing that would suggest off-label usage, firms should begin reviewing their internal search indexes and implement negative tags that exclude possible off-label results appearing on brand-name searches. On-site search should also clearly label whether searches are done for all the words in the query or any word in the query. Here the issue might be that a user searches for both the brand and an off-label use. If the search results are not properly coded, then simply returning results could make it appear that the firm is promoting off-label use of a product. Frequently Asked Questions: While it may seem rational or tempting, the FDA makes it clear that unsolicited off-label requests must be responded to only in private communications. Because of this, no matter how frequently a question is asked, if it is off-label, it should never be included in Frequently Asked Questions—type features. Newly Approved Indications: As prescription drugs go through their product lifecycles, some drugs will see previously off-label uses become approved indications. The FDA discusses some of the challenges online forums may represent on page 10 of the guidance, however the recently released FDA guidance doesn’t provide specific examples or guidance on off-label requests becoming on-label requests in the future. What the pharmaceutical industry can infer from the FDA’s guidance is that the decision to respond to off-label, unsolicited requests and the timing of said response rests solely with pharmaceutical companies. This means that pharmaceutical companies are able to respond to or follow up on past off-label requests detailing new information on that request now being on-label. For drugs that are expected to receive multiple indications or potentially be used off-label until those indications are approved, pharmaceutical companies should keep track of unsolicited off-label requests because in the future these requests may become on-label and could be a key source of communicating and selling in a drug’s new indication and use. But we recommend caution and careful review before responding to these types of “requests.” RTCRM Proprietary Page 3
  4. 4. ConclusionAll in all, this new guidance is not the groundbreaking social media guidance that some have made itout to be. It is groundbreaking in terms of companies being able to respond to unsolicited off-labelrequest and does provide some additional clarity around social media engagement, but it is notcomprehensive of social media platforms, technologies and marketing strategies. As always, marketersshould firmly stick to approved indications and always provide fair balance and required safetyinformation along with any response. For medical information teams, this new guidance does providean avenue to better serve the public and answer consumers’ and healthcare professionals’ questions.Companies should examine existing networks and Web properties to ensure they are compliant withthese recommendations. Begin by reviewing internal site search and introducing a more concisetagging structure that will guarantee off-topic or off-label content will not show up through internalsite searches. Additionally, make sure that existing protocol for answering consumer and HCPquestions through Web channels does not link to or allude to any off-label information. Due to thevariability of individual web properties, begin your review process by consulting the Use Cases toConsider Section above for examples of guidance compliance.About the Digital Integration and Innovation Team The RTCRM Digital Integration and Innovation team is tasked with keeping track and making sense of the ever changing digital world. It’s our job to understand the nuances of how and why different types of people usetechnology and what that tells us about them. More importantly, it’s our job to help our clients applythis knowledge to better communicate with their customers. We help clients translate business goalsinto marketing campaigns that build relationships with customers. In the 21st century, understandinghow and why someone uses technology is as important as understanding where they live, what genderthey are, and how old they are. That’s where we come in. From ensuring that digital behavior isconsidered in the research phase, to tactical plans that align digital, print and broadcast tactics, wework with clients and internal partners to make sure it all works.It’s not about what’s cool. It’s about what works.About RTCRMRTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketingagency based in Washington, D.C., in the heart of Georgetown, with an additional office in New York.RTCRM boasts more than 40 years’ worth of innovative, targeted solutions that grow its clients’ brandsand help them forge lasting, valuable relationships with their customers. What distinguishes RTCRM isits unique ability to analyze data and research on both a rational and emotional level. RTCRM’s clientsinclude major brands in the telecom, technology, pharmaceutical, and other business sectors such asAARP, BlackRock, Eli Lilly, and Novo Nordisk.To learn more about RTCRM, please visit or follow the Twitter feed @rtcrm. RTCRM Proprietary Page 4