The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it. However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications.
Connecting with Patients, Overcoming Uncertainty
September 2007 A white paper on Managing the Risks and Regulatory Issues Associated with Successful Pharmaceutical Social Media Monitoring and Marketing
In the absence of FDA guidance on marketing in blogs, social networks and other social media forms, drug firms' marketing, compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This paper provides a framework to clarify and mitigate the risks of a range of social media initiatives.
3 Part I: Social Media, Healthcare and the Pharmaceutical IndustryThe Internet's influence on healthcare providers, patients and drug firms has grown dramatically in the past decade. Social media's impact will grow as patients become more assertive in their healthcare decisions. Who should read this section: those new to social media communications.
7 Part II: An Overview of the Legal and Regulatory Environment for Direct-to-Consumer Promotion A few key principles underlie the FDA's regulatory approach to pharmaceutical marketing. Incorporating them into social media initiatives will decrease the potential for unwanted FDA scrutiny. Who should read this section: those with limited knowledge of current FDA regulations or seeking a "refresher" course.
17 Part III: Social Media Marketing: A Strategic Regulatory Framework The authors propose a framework that will help drug firms discuss, evaluate and minimize potential compliance risks associated with social media monitoring and marketing. Who should read this section: marketers, regulatory compliance and legal professionals involved in social media monitoring and marketing programs.
Tables
. Table 1: Four Types of Social Media Content Creators Impact Pharmaceutical Companies................................................................................................................ 5 . Table 2: Selected Requirements for Contents of Print and Broadcast Product Claim Advertisements .......................................................................................... 11
. Table 3: Common Examples of How Pharmaceutical Companies Have Complied With FDA Regulations ..................................................................... 15
. Tables 4-7: Evaluation of Risks Associated with Social Media Activities ............. 20 About
TNS Media Intelligence/Cymfony Cymfony, a division of TNS Media Intelligence, tells brands and companies what people are saying about them whether the people are bloggers, traditional journalists or even influential consumers. By sifting and interpreting the millions of voices at the intersection of traditional and social media, Cymfony delivers consumer insights that help companies identify the people, keep on top of the issues and respond to the trends impacting their business - at the speed of the market. For more information visit www.cymfony.com or contact Jeff Barovich at either 617-673-6051 or jbarovich@cymfony.com.
Envision Solutions, LLC Envision Solutions, LLC is a full-service healthcare marketing communications consulting firm. The company provides innovative products and services to not-for-profit and for-profit organizations. Envision Solutions core competencies are in the areas of analysis, strategic and tactical recommendation development, training and content development. Please visit www.envisionsolutionsnow.com for more information about the firm or contact Fard Johnmar at either 212-501-6101 or info@envisionsolutionsnow.com
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