Social media isn't going away, so what does a biotech brand manager need to know to get FDA approval? You already know. Proceed accordingly.
Americans look to online and offline sources to obtain their healthcare information. The Pew Internet/California HealthCare Foundation found that 61% of Americans turn to the Internet first when seeking health-related information. Yet, the pharmaceutical and medical device industries have been slow to establish a social media presence, perhaps because of minimal guidance from the FDA.
According to Jeremy Green, MD, PhD, and Aaron Kesselheim, MD, JD, MPH, in their recent article, Pharma Marketing and the New Social Media, published in The New England Journal of Medicine, it is unclear how to provide fair balance in the dynamic and expanding matrix of networked media—not to mention in a 140-character Twitter post or the limited space available in banner ads.
For static websites and some banner ads, companies have been using a “one-click rule,” ensuring that risk information was no farther away than a single tap of the finger. Industry expectations are that the FDA will issue guidance documents in 2011 to explain how the agency feels about this practice. Until then, you will continue to see usage of the one-click rule.
Another important consideration is that once a promotional message enters the social media space, the pharma company loses control over the content. Speakers at a recent social media conference felt that once a promotional message enters cyberspace, the FDA can't hold companies accountable for any misrepresentation of risks made by bloggers, posters, and Twitter users.
Tom Abrams, Director of DDMAC, and staff members have said that DDMAC reviews the message and not the medium. If you follow that thought, then biotech brand managers shouldn't wait to get into social media before they know the rules. Biotech brand managers know the rules. They are the same rules as for print, TV, and radio. Just add digital to the mix. DDMAC wants physicians and consumers to receive balanced information, or the good and the bad with equal emphasis.
When the FDA finally issues new guidance, there will probably be an explosion of marketing in online social media, as there was in print media in the 1980s and broadcast media in the 1990s.
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