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Nearly everything we do at Sanofi US, including engaging with each of you through our social media channels, is governed by rules and regulations. I asked Allison Gassaro, Associate Vice President and Associate General Counsel for Sanofi US Legal, to shed light on some of the legal requirements Sanofi US abides by and how it impacts the way we engage with the diabetes online community.

Q: Will you start by telling us about yourself, your team and what you’re responsible for?

A: I have been with Sanofi US for just over 10 years, providing legal counsel for the North America Pharmaceuticals group, including coordinating with our Social Media Task Force. I am a team of one with support provided by the department’s two specialists who split their time among the attorneys in our group. Together, we are responsible for legal support of General Therapeutics, US Biosurgery and Cardiovascular Business Units. We also provide legal support to the Digital Center of Excellence, which is how I became involved in social media.

Q: In 2010, you helped start the Social Media Task Force at Sanofi US. Can you share the purpose of the Task Force and your specific role?

A: The purpose of the Task Force is to serve as a cross-functional group tasked with developing guidelines for participation in social media. This includes providing guidance and input for our existing channels as well as potential participation in new social media platforms and tactics. My specific role is legal counsel to the Task Force. I provide input on various legal issues and implications and collaborate with Regulatory Affairs to ensure we meet regulations set forth by the FDA.

Q: Since you mentioned Regulatory Affairs, are there rules from a legal perspective that mirror those previously shared by Mark Gaydos, Vice President Regulatory Affairs Marketed Products, that pharmaceutical companies must follow?

A: To a large extent, many of the regulatory issues are in fact legal issues, in the fact that these laws implement regulations we must follow. In addition to FDA rules and regulations, there are other general legal concerns with original content that we create and publish and user-generated content associated with participating in social media. They include:

• Federal Trade Commission rules regarding bloggers and the use of testimonials and endorsements
• Potential liability issues including copyright and trademark infringement
• Defamation and false information
• Privacy issues

Other issues include the concern for engaging in the practice of medicine, employment issues, online contracting issues, brand protection, e-discovery, and the list, trust me, goes on and on.

Q: In your opinion, what legal issue impacts the ability for Sanofi US to engage through social channels the most?

A: Likely FDA rules and regulations, including pharmacovigilance requirements which involve monitoring and reporting adverse events, including side-effects that might arise from the use of a product.

Q: Does the lack of specific FDA social media guidelines present an additional legal challenge when it comes to engaging online?

A: It can be viewed as a both a challenge and an opportunity. The challenge lies in the fact that there is little on-point and the current rules and regulations were drafted without social media in mind. At the same time, I see it as an opportunity to be involved at the start and to try to help shape regulators’ views and perceptions about social media and influence the drafting of practical guidance documents and regulations.

We hope that the diabetes community understands that we are figuring this out as we go. The answer as to how or when we engage isn’t always readily available or clear because the law tends to lag behind technology. Social media does present a great chance to connect and provide information, but we have to ensure that we stay within the existing rules and regulations used to govern.

I really appreciate Allison’s comment about social media being an opportunity, not just a challenge from her legal perspective. It gives me hope that we’re making progress and the future is bright. Thanks to Allison for taking the time to share this information with our readers.

All the best,

Laura K.

This entry was posted on Monday, June 25th, 2012 at 5:00 am and is filed under General, Services. You can skip to the end and leave a response. Pinging is currently not allowed.