On June 17, 2014, the Food and Drug Administration (FDA) released two additional draft guidances that put greater definition around how pharmaceutical and medical device companies can use social media. The first guidance focuses on using social media platforms with space limitations, such as Twitter. The second deals with how to correct third-party misinformation about prescription drugs and medical devices.
The long-awaited draft guidances are consistent with the FDA’s previous statements and enforcement actions that set out a conservative and limited role for product sponsors. It does appear, however, that the FDA is willing to give companies more freedom than might be expected to correct inaccurate information about their products that appears on the web.
Although the documents tackle different topics, Thomas Abrams, the director of the FDA’s Office of Prescription Drug Promotion, sees them as having a common goal. In a blog posted on “FDA Voice,” Mr. Abrams says the documents both “strive to ensure that the information provided by drug and device companies is accurate and will help patients make well-informed decisions in consultation with their healthcare providers.”
The Growing Need for Clear Direction
Few would argue that there has been a pressing need for guidance around social media use. A survey for the CDC shows that 59% of physicians use social media sites—and a Pew Research Center study reveals that 80% of adults who use the Internet have looked online for health information, a quarter for reviews of specific drugs and treatments. Yet an IMS Health study announced early this year that just 23 of the top 50 global pharmaceutical companies make regular use of social media. In addition, Tufts University research shows that just one in five companies uses social media to engage with patients.
The lack of clear guidance has contributed greatly to the industry’s reticence to use social media. Abrams acknowledged on his blog that companies have been seeking greater clarity, saying “We developed these new guidances, in part, to respond to requests for best practices from companies and other stakeholders.”
Greater Certainty around Engagement—but Strict Limits Remain
The guidances provide drug and device manufacturers with more certainty about the rules governing their engagements in web and social media communications. They continue, however, to reinforce the FDA’s very strict limits on those vehicles. Overall, the guidances:
- Confirm that FDA insists that social media communications be complete and balanced within the initial message (i.e., the tweet).
- Make it clear that it may be impossible for some products and services to use certain social media and Internet contexts—particularly those with limited character counts—and still meet the FDA’s requirements.
- Clarify when the FDA will hold a company responsible for Internet and social media content and when it will not.
- Allow companies to host un-moderated discussions on controlled web sites without being accountable for all that is said.
- Give permission and pathways for companies to correct misinformation on independent sites—but do not require that they create comprehensive programs or monitor all web sites or even all discussions on the sites they choose to correct.
Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
Click here to access the full guidance.
The draft guidance on platforms with character space limitations covers current platforms, such as Twitter and sponsored links, as well as future platforms that may impose similar limitations. Its focus is on “the communication of benefit and risk information on Internet/social media platforms with character space limitations.…”
The central theme is fair balance—ensuring that any communication conveys both benefit and risk information in a balanced fashion. In its language, the guidance clearly drives home the need to achieve fair balance within a single communication:
- “FDA acknowledges that Internet/social media platforms associated with character space limitations may pose challenges for firms in providing a balanced presentation of both risks and benefits of medical products.”
- “If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message….”
- “[I]f a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.”
Following is a summary of the key requirements set forth in the FDA guidance:
- Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
- Benefit information should be accompanied by risk information within each individual character-space-limited communication.
- If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, the firm should reconsider using that platform for the intended promotional message.
- The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product. For a prescription human drug, the most serious risks would generally include all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling (the PI).
- A mechanism, such as a hyperlink, should also be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product. Firms may include supplemental hyperlinks (e.g., to a product home page, a PI or a brief summary) either within the character-space-limited communication itself or on the landing page of risk information. FDA recommends, however, that a direct hyperlink to a landing page that is devoted exclusively to comprehensive risk information about the product be initially included within the original character-space-limited communication.
- The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
Click here to access the full guidance.
The draft guidance on correcting third-party misinformation states that companies “should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media or other technological venues (Internet/social media)….” For the guidance to apply, the misinformation must be within content generated by a third party, regardless of where it appears. In other words, even comments on the company’s own web site, if posted by an independent third party, are covered by the guidance.
Following is a summary of key requirements set forth in the FDA guidance:
- Misinformation is defined as positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular way. FDA has determined it may benefit the public health for firms to correct misinformation about their products (including, for example, situations in which a firm is aware of misinformation that may be dangerous or harmful to the public health).
- This draft guidance does not apply when a firm is responsible for the product communication that contains misinformation. A firm is responsible for communications that are owned, controlled, created, influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm. A firm is therefore responsible for communications on the Internet and Internet-based platforms, such as social media, made by its employees or any agents acting on its behalf to promote its product. These communications must comply with any applicable regulatory requirements.
- Firms are generally not responsible for third-party user generated content (UGC) about their products when the UGC is truly independent of the firm (e.g., is not produced by, or on behalf of, or prompted by the firm in any particular way) regardless of whether the firm owns or operates the platform on which the communication appears. If the firm owns or operates the platform or created or initiated the forum on which the UGC appears, the firm should include an overarching clear and conspicuous statement that the firm did not create or control the UGC. (It is permissible, however, to monitor the forum for profanity and obscenity without triggering responsibility for its content.)
- A firm may choose to provide appropriate truthful and non-misleading corrective information. Alternatively, it may provide a reputable source from which to obtain the correct information, such as the firm’s contact information.
The draft guidance sets out specific requirements for corrective information, including:
- The corrective information must either:
- Be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum), or
- Reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum’s operator or author).
- The corrective information must disclose that the person providing it is affiliated with the firm that manufactures, packs or distributes the product.
- If a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum. A firm should, however:
- Clearly identify the misinformation it is correcting,
- Define the portion of the forum it is correcting, and
- Correct all the misinformation that appears in that clearly defined portion.
- If a firm chooses to correct misinformation, it may do so by correcting misinformation directly on the forum. Alternatively, the firm may provide the corrective information to the independent author for the author to incorporate. The firm may request that the author remove the misinformation or allow comments to be posted. The firm also may request that the site administrator remove the misinformation or allow comments to be posted.
- FDA will not hold a firm accountable for an independent third party’s subsequent actions or lack of action.
The draft guidance suggests that firms keep records of their efforts to correct misinformation. The records should include:
- The content in the misinformation.
- The date it was posted or located.
- The forum to which it was posted.
- The corrective information provided.
- The date the corrected information was provided.
To Be Continued…
The draft guidances are the latest in a series. The agency is planning to continue refining and expanding its guidance around social media and Internet communications. As Abrams says in concluding his blog, “FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency’s current thinking. We do all this work with the best interests of patients in mind.”