It’s been nearly five years since drug makers and other in the industry were promised FDA-approved guidelines as a part of the Prescription Drug User Free Act (section 1121.) For many drug companies, the lack of guidelines has hindered their marketing outreach due to fear that any participation in social media (or online advertising for that matter) could result in fines or penalties based on unclear policy and regulation.  This week, the FDA released a 10-page document that outlined the first in what promised to be more concise guidelines for the industry, which are due in July of this year as a part of the 2012 FDA Safety and Innovation Act (FDASIA) which requires the agency to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products” that it regulates.  The bulk of the drafted guidelines still focuses on the POSTmarketing requirements that have long been in question with regard to social media and online advertising.  Continue reading→