Medical Device Companies' Concerns About Social Media Remain Justified

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Consumers increasingly rely on the Internet and social media outlets such as Facebook, Twitter and Wikipedia for health information. In 2009 alone, more than 80 million consumers, about 35 percent of all U.S. adults, used social media for health and medical purposes. And a whopping 8 in 10 Internet users, or 61 percent of U.S. adults, have researched online for health and medical information. Despite consumers' growing dependence on this medium for health information, the Food and Drug Administration (FDA) has not yet issued definitive regulations or guidelines addressing drug and device manufacturers' use of social media to market their products. For this reason, medical device companies understandably have been reluctant to use social media to provide even the most basic information about FDA-regulated products for fear of criminal investigations, government fines and civil lawsuits.

The industry's reluctance appears to be well founded as demonstrated by the FDA's most recent enforcement action concerning promotional materials. On August 4, 2010, the FDA's marketing regulatory arm, the Division of Drug Marketing, Advertising, and Communications (DDMAC), posted to the FDA website a notice of violation letter ("untitled letter") to a major pharmaceutical company. The letter accuses the company of using the popular social networking site, Facebook, to improperly promote its leukemia drug. According to the letter, the company's U.S. website contains a "Facebook Share" widget that allows Facebook users to share company generated information with other Facebook users (i.e., "shared content").

The "Facebook Share" widget is a clickable button placed by the company on the webpage for the leukemia drug. Visitors are able to share the webpage by clicking the button, which generates shared content - a link and brief description of the webpage for the drug - to be shared with the Facebook user's friends. For example, shared content from a "Facebook Share" widget from one of the consumer WebPages for the drug makes a claim that it is a "next-generation treatment for Ph+ Chronic Myeloid Leukemia in adult patients in chronic or accelerated phase who are resistant to Gleevec."

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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