Posted by & filed under Life Sciences.

According to the new FDA Guidance on Postmarketing Submissions, organizations are responsible for reporting on comments made by employees and agents on social media sites about the organization’s products.

Agent = “anyone acting on behalf of the firm.”

It’s great that the industry does not have to report on “promotional” comments made by non-agent users, however, how can you track all of the comments made about your product by your employees and agents without creating a significant workload?

  1. Train ALL of your agents on your social media policy. All of them. Not sure if someone is an agent? There is definitely brevity to the guidance, however, an agent would include your agencies, Opinion Leaders, speakers, bloggers, influencers and other advocates over which you have “influence.” Still not sure? Remain conservative until you can get clarification.
  2. Monitor public social media sites, and all sites for which you have responsibility (see draft guidance), for ALL references to your product names. Ensure your monitoring software can alert you to infractions in multiple policies and regulations. In other words, there are currently products available that can monitor, capture, analyze, alert and archive – a new solution for this purpose alone is not necessary.
  3. Make reasonable efforts to identify employee and agent posts about your products. Ensure you are not overstepping your bounds in regard to employee privacy. Make sure your policies are clear, and obtain necessary approval in advance.
  4. Don’t forget: you still want to evaluate the data you collect for Adverse Events (link to policy) Anti-Kick Back (link to policy), HIPAA (link to policy), adherence to endorsements governed by the FTC*, and others.
  5. Report. Once you have the information an audit trail can help demonstrate risks identified and mitigation steps.

Essentially, organizations have been providing social media risk management and compliance services to other industries for years. However, the next generation technologies are more flexible and able to accommodate policies and platforms with ease. OpenQ has been providing social interaction risk mitigation to companies in BioPharma/Medical Device & Healthcare industries since 2005. Our Social SafeGuard solution allows you to meet the needs for this, and dozens of other regulations & policies with ease. Consider SafeGuard your “anti-virus” solution for social media risk identification and mitigation.

* Under this law, organizations are required to make “reasonable efforts” to know what is being said about their brand. Visual endorsement disclosures require attention to prominence, presentation, placement and proximity and may be subject to other industry-specific laws and regulations.  Lastly, “companies should require—and vigilantly monitor and enforce—that all endorsers honor their obligation to properly disclose any incentives they receive to promote the company’s products or services….the company’s internal personnel, but that of outside agencies hired by the company as well.”[ii]  Company policy should disclose requirements for endorsements by employees and contractors.

[ii] “Navigating Social Media Legal Risks: Safeguarding your Business,” p 49.  (Robert McHale, 2012)

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