Healthcare Law Blog

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In June, the U.S. Food and Drug Administration issued two draft guidance documents for the pharmaceutical and medical device industries related to social media.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 the 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The other draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, addresses how manufacturers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, the 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Manufacturers may submit comments regarding the draft guidance documents to the FDA until September 16, 2014.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 (“Model Policy”) that was issued by the Federation of State Medical Boards (“FSMB”). 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.

If you are a health care provider and have questions about drafting or implementing social media policies for your health care organization, contact a McBrayer healthcare attorney today.

This article is intended as a summary of federal and state law and does not constitute legal advice.

McBrayer Attorneys Present at NADSA Conference

On October 10, 2013, three McBrayer attorneys spoke at the 2013 National Adult Day Service Association Conference held in Louisville, Kentucky. Lisa English Hinkle, Jaron P. Blandford, and Cynthia L. Effinger presented, " Hot Topics in Employment Law: Social Media; the Intersection of HIPAA and the NLRB; and Everyday Challenges." The seminar discussed several important employment law updates for adult day service providers. You can download a copy of their presentation here: 2013 NADSA Conference.

The Kentucky Board of Medical Licensure Adopts the Model Policy, cont.

Earlier this week, I began the discussion about the Kentucky Board of Medical Licensure adopting the Model Policy. While the Model Policy serves as a cautionary reminder of the hazards of social media, it also emphasizes the “enormous potential” social media has for both physicians and their patients. As telecommuting grows, electronic health records are implemented, and smart phones find their way into more and more physicians’ hands, it is obvious that shying away from technology is no longer an option. Nor should it be, as the use of social media really does have its benefits: reduced costs, improved physician-to-physician sharing and learning opportunities, the crossing of geographic boundaries, and a way to provide important information to the public. More >

The Kentucky Board of Medical Licensure Adopts the Model Policy

Over the summer, the Kentucky Board of Medical Licensure adopted the Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”) that was issued by the Federation of State Medical Boards (“FSMB”). FSMB created their policy in 2012 to help medical boards provide guidance and education about issues related to social media. The FSMB Model Policy followed the American Medical Association’s (“AMA”) 2010 “Professionalism in the Use of Social Media” policy. Both incorporate the same principles, but the FSMB offers more concrete examples of conduct that should be avoided in social media activity. More >