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Over the past few months, we’ve shared information about who we are as a company, a few of my personal observations from the DOC, and some helpful resources we have found. Behind each post is a team dedicated to ensuring we comply with applicable regulations (a big thanks to them). Given that I had little to no knowledge about pharmaceutical regulations when I joined sanofi-aventis U.S., I thought this might be an appropriate time to introduce Mark Gaydos, Acting Head of U.S. Regulatory Affairs Marketed Products, to give you a glimpse into the pharmaceutical industry and the rules that come along with it. Here’s what he had to say…

Q: Mark, can you tell us a little about yourself and your role at sanofi-aventis U.S.?

A: First off, thanks Laura for setting up this interview. For a little bit about me, I’ve been at sanofi-aventis U.S. since early 2004, and I’m currently the acting head of the U.S. Regulatory group. My core responsibility is to ensure that our company complies with the Food and Drug Administration’s (FDA’s) regulations related to drugs and medical devices. This includes regulations regarding the marketing of pharmaceuticals directly to consumers.

I have also taken an active role in helping to develop guidelines for sanofi-aventis’ participation in social media channels, where my primary objective has been to determine how we will comply with applicable rules and regulations while having meaningful conversations with our patients and other customers. Social media has opened new doors for how we, as a company, can communicate and we want to embrace it in a responsible manner. The “Discuss Diabetes” blog is one example of an innovative approach to customer engagement, one that will give us opportunities to learn from people living with diabetes and ideally improve our offerings for them. We know it’s important to better understand our customers and the community’s needs, so the work the Diabetes Division is doing is a big step forward for us.

Q: In a nutshell, what are a few general rules pharmaceutical companies need to follow in order to comply with FDA regulations?

A: For those who aren’t aware, the pharmaceutical industry is regulated by the United States Food and Drug Administration. The FDA has long-established regulations specific to pharmaceutical company communications related to its products. They have also issued guidance on complying with those regulations.

Content is considered “promotional” when it contains the brand name of a product, or otherwise identifies a specific product, and other information about diseases or conditions the product is used to treat. In such cases, a pharmaceutical company must present a balanced presentation of the benefits and risks associated with that drug. This is commonly called “fair balance,” which ensures an accurate and fair assessment of the risks, as well as the benefits of the treatment. Among other basic requirements are that a company may only promote FDA-approved uses of its products and that company statements about its products must be accurate and not false or misleading. These elements do not apply to company communications that do not identify its products, such as strictly disease-oriented materials.

Q: How do you see Discuss Diabetes as a way to help connect with the diabetes community, while ensuring regulatory compliance?

A: You can probably speak to the “connecting” part a little better than I can, Laura; but, the intent of “Discuss Diabetes” is to provide a lot more than just information about our treatments — it’s about how we, as a company, take a more comprehensive approach to understanding the needs of people living with diabetes, such as the condition’s impact on lifestyle modification, etc. Since all content needs to be evaluated by our Review Committee, one of the big differences is time. Sometimes it takes us a few days before we can approve a particular comment, post a response or publish a post. It may seem a little slow, when compared to the instant gratification that generally accompanies social media, but this review process allows us to be certain we are complying with existing regulations. If any promotional content is shared, we are required to submit that to the FDA, which can also add extra time. I know social media can move faster than the speed of light; but, as a company in this regulated industry, we have to be sure we’re meeting FDA requirements, while also acting as rapidly as possible to meet the requests and needs of the community.

Q: There have been a lot of discussions about the anticipated FDA Guidelines on social media. Why are they so important?

A: The FDA is working on a number of guidance documents that will address specific aspects of the pharmaceutical industry’s participation in social media. Although overarching regulations exist, they were written decades before the advent of the Internet and social media. Existing regulations and guidance are more geared toward traditional channels such as television and print. Nonetheless, the basic principles of balance, accuracy, and promotion of FDA-approved uses, still apply as I described earlier. Once the FDA issues its initial social media guidance, we will evaluate it and determine how it might affect our own engagement. And you will have the opportunity to let the diabetes community know how, if at all, it impacts our ability to engage with them going forward.

Laura: Yes, I will. And thanks, Mark, for taking the time to speak with me. I know there are plenty of folks that do not understand why it can be challenging for pharmaceuticals to engage in social media, so I hope this interview helps provide some context behind our rules of engagement.

If you have any additional questions for Mark, please let us know. We would love to hear from you.

Best,
Laura

This entry was posted on Monday, March 28th, 2011 at 5:05 am and is filed under General. You can skip to the end and leave a response. Pinging is currently not allowed.