Trying to interpret the FDA’s social media guidelines is well – up for interpretation.
However, it does pave the way for correcting the gross inaccurate health information that floods the web everyday. Pharma companies often struggle with misinformation on the web and have been unable to amend or respond to those misnomers and 3rd parties.
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.
For this session we will focus on the misinformation and what a pharma company can do.
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
The draft guidance on correcting third-party misinformation says that companies “should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved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)….”
Here 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.
- The 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).
- Any 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.
Here are the specific requirements for corrective information:
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 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.
I know thats a lot to take in but this is heading in the right direction.
For full guidance documents click here to access.