FDA guidelines and social media for the pharma industry

Rodica Ceslov

Wild Frog Studio

As a follow up to her recent article on the challenges associated with social media use within the pharmaceutical industry, Rodica Ceslov explores the regulatory environment in this area.

The challenge associated with social media and the pharmaceutical industry is how to meet regulatory compliance while utilizing this online tool. This no doubt creates easily accessible and (more importantly) consumer-contributed marketing strategies, possibly broadening a representation of a drug beyond what some governing bodies would find acceptable. There are no published guidelines by the Food and Drug Administration (FDA) with regards to social media, but pharma companies often find themselves interpreting their internal policies based on what is already in place, then hoping a user comment doesn’t violate a code once it drifts out into the ether. Some companies, by sharing information on a certain drug on Facebook, have been cited by the Division of Drug Marketing for violating the FDA regulation on disclosure, making “representations” of what a drug can do but not communicating any risks. On Facebook, companies find themselves trying to guide or control user content so nothing can be considered a regulatory violation (which might defeat the purpose of allowing comments on Facebook, Facebook’s initiative to disallow any disabling of comments furthers a possible problem). A company might also release some marketing material on Facebook or Twitter having met the internal compliance code, only to host non-regulated user content generated by the second1.

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“…pharma companies often find themselves interpreting their internal policies based on what is already in place, then hoping a user comment doesn’t violate a code once it drifts out into the ether.”

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Comment or forum moderation could be a solution, with the goal of making sure everything hosted by the site complies with the regulatory codes in place — guidelines to ensure nothing falls through the cracks for the FDA or some other regulatory body to conceive as violation. It should be noted that any application of the existing regulations is enforced on a case-to-case basis, lacking any consistency, with a lot of companies asking the FDA flat-out for an official social media policy to quell any risks. The spread of viral information in this current era of massive real-time communication has a giant upside for pharmaceutical companies and a mysterious downside, not knowing for sure what could happen and how the regulatory policies in place can be interpreted. As the pharma industry increases their expenditure in social marketing steadily, the need for an updated system of regulation rises at the same time2. Big Pharma, for example, spent $1 billion in online advertisement with no discernible guidelines, and expects to spend even more in the next two years3.

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“The spread of viral information in this current era of massive real-time communication has a giant upside for pharmaceutical companies…”

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A company would like to control what is being said about a new drug, and share little information — a more traditional marketing mentality. To restrict information in this way is to keep communication close and not risk losing intellectual property. Social media does a lot to colorize this relatively lifeless strategy, propagating conversation among real consumers in real-time while also diminishing the cost of reaching consumers using traditional methods. Adverse unregulated reporting or comments are a risk, but the companies that can find a path through these times will no doubt find a lot of success4. Perhaps waiting for a finalized regulation is waiting too long, and to rise among their peers, a company should see this as a period where a their own interpretation of current guidelines will indicate how they will work in the future5.

The current “Guidance for Industry” regarding unsolicited requests for information about drugs by the U.S. Department of Health &amp, Human Services can be found here: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf

References

1. Ally Bershadsky &amp, Anuradha Roy. “Creating Globally Compliant Social Media Programs for Pharmaceutical and Medical Device Companies”. Pharmaceutical Compliance Monitor. 12/20/2011. http://www.pharmacompliancemonitor.com/creating-globally-compliant-social-media-programs-pharmaceutical-medical-device-companies/.

2. Matthew C. Nisbet. “Drug Companies Wait for FDA Guidelines on Social Media Marketing”. Big Think. 11/17/2011. http://bigthink.com/age-of-engagement/drug-companies-wait-for-fda-guidelines-on-social-media-marketing.

3. Rich Thomaselli. “FDA’s Social-Media ‘Guidelines’ Befuddle Big Pharma.” Ad Age Digital. 12/30/2011. http://adage.com/article/digital/fda-s-social-media-guidelines-befuddle-big-pharma/231855/.

4. Daniel Siddle. “What Use Is Social Media to the Pharmaceutical Industry?” Headshift. 6/29/2009. http://www.headshift.com/our-blog/2009/06/29/what-use-is-social-media-to-th/.

5. Rich Thomaselli. “FDA’s Social-Media ‘Guidelines’ Befuddle Big Pharma.” Ad Age Digital. 12/30/2011. http://adage.com/article/digital/fda-s-social-media-guidelines-befuddle-big-pharma/231855/.

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About the author:

Rodica Ceslov is president of Wild Frog Studio, a dynamic full-service firm helping companies create go-to-market strategies and execute product launches for new products, new product line extensions and re-packaging existing products. She has worked for clients in a variety of industries, including: health care, pharmaceutical, technology, real estate, publishing, management consulting, non profit, retail, food, beauty and entertainment.

For more information, go to http://wildfrogstudio.com.

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What use is social media to the pharmaceutical industry?