Wednesday, August 20, 2014

FDA Issues Guidance for Drug & Device
Companies’ Social Media Interactions

In June, the U.S. Food and Drug Administration issued two draft guidance documents for the pharmaceutical and medical device industries related to social media. The guidance is part of an asserted effort by FDA to provide more clarity regarding how drug and device manufacturers may appropriately communicate through Internet platforms.

The first document, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, addresses advertising and promotional communications concerning prescription drugs and medical devices on sites where character space is limited, such as Twitter and sponsored search engine results. The guidance specifies, among other things, that each “tweet” must include both benefits and risks of the promoted drug and should include a hyperlink to a more comprehensive list of risks and side effects.

The other draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, addresses how manufacturers may correct certain misinformation posted by independent third parties and in chat rooms. As long as the information appears on a site not controlled by the company, FDA does not mandate that a company correct the misinformation. If, however, the company chooses to correct the misinformation, they must follow certain protocol as outlined in the guidance.

Manufacturers may submit comments regarding the draft guidance documents to FDA until September 16, 2014. While the guidance is solely issued for pharmaceutical and medical device companies, all providers must use caution when using social media to promote their services, practice group, a certain procedure, etc. In 2013, the Kentucky Board of Medical Licensure adopted the Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice that was issued by the Federation of State Medical Boards. See more on the adoption here.

The unintended consequences of social media can lead to real consequences, as even seemingly innocent and inconspicuous postings and interactions can result in costly and serious repercussions. Inappropriate postings or patient-physician communications can lead to violations of HIPAA and the Kentucky Medical Practice Act, licensing violations, or even fraud and abuse charges (i.e., physicians pay money to third parties to promote their services through online media platforms). The FDA guidance, even if not binding on a particular health care profession, is still informative and can serve as a great reference tool in policymaking.

Molly Nicol Lewis
mlewis@mmlk.com
McBrayer, McGinnis, Leslie & Kirkland, PLLC
Lexington, Kentucky

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