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FDA releases long-awaited “social media” guidelines

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Last week the FDA released two new draft guidelines. These documents provide directional guidance about pharma’s options to engage with social media and user-generated content. While the FDA offers examples for consideration, marketers will need to evaluate their own tactics and materials on a case-by-case basis. The Insights & Innovation department has reviewed the guidelines and boiled it down to the following highlights:

Guidance A: “Correcting Independent Third-Party Misinformation”

What: In this guidance, the FDA speaks to when and how a pharma company can respond to misinformation about their brand that has been posted by a third party (e.g., patient, doctor, blogger).

Key Takeaway: Though pharma companies aren’t required to respond to misinformation, they can and should. They need to follow risk/benefit guidelines and clearly specify what information they are fixing.

The Details:

1. If a company chooses to respond, responses must be relevant, specific, accurate, and non-promotional

2. Companies must correct a clearly defined portion; correcting the entire forum is not required

3. Within a clearly defined portion, companies must correct both negative and positive misinformation

4. A company can either directly respond to misinformation or reach out to the author outside of the forum for correction

5. Companies are not expected to continue to monitor/respond to responses after correcting misinformation

Guidance B: “Character Space Limitations – Presenting Risk and Benefit Information”

What: In this second guidance, the FDA speaks to how a pharma company can use social media posts/comments/shares/tweets (i.e., shareable content) in a branded environment when there is limited character space. The FDA also suggests guidance for sponsored links such as those on Google where there are also character requirements.

Key Takeaway: Pharma companies can use social media posting and sponsored links, but they need to follow risk/benefit guidelines as they would in any consumer marketing material. While the FDA acknowledges that character limitations make this difficult, they make it clear that their expectations haven’t changed just because it’s social media or because there is limited space. They do try to provide examples of how to work within these confines. Products with long brand names, long generic names, and heavy risk/benefit language will have a hard time using this medium in a branded way. Not too mention, you won’t have any room to say anything compelling.

The Details:

1. Each message or post must contain fair balance

2. Each message or post should contain benefit, risk, and key product information

3. Benefit information should be accurate, non-misleading, and have equal weight compared to the risk information

4. Risk information should include the most serious risks and link to an overview of all risk information

5. The brand name, generic name, and one specific dosage form should be available along with each message or post

As always, we welcome questions and comments, and we are available for briefings and working sessions to discuss these guidelines.

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