FDA Issues Draft “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”


On January 13, 2014, the Food and Drug Administration (“FDA”) issued its draft “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (the “Guidance”). Although it contains nonbinding recommendations, this long-awaited draft Guidance provides pharmaceutical drug and biologics manufacturers with the FDA’s current thinking on how to fulfill their post-marketing regulatory requirements for submission of “interactive promotional media” as it relates to their FDA-approved products. [Read more...]

Make Your First Step into Social the Right One


Social media and the pharmaceutical and biotechnology industries are not known to be comfortable bed fellows.
 
According to a report released by the IMS Institute for Healthcare Informatics, only half of the top 50 pharmaceutical companies worldwide actively participate in social media on Facebook, Twitter or YouTube. And only 10 of these companies utilize all three of these major social networking services for healthcare topics, and then mainly as a unilateral broadcasting channel to physicians and patients, rather than fostering interactions or discussions.
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New Rules for Navigating the Blogosphere and Twitterverse: FDA’s Draft Guidance on Submissions of Interactive Promotional Media

On Tuesday, 14 January, the FDA issued a long-awaited guidance addressing use of social media and other “interactive promotional media” in the marketing of medical products. Although the focus of the guidance relates to when such activity constitutes “labeling” under the Food, Drug, and Cosmetic Act (FDCA) and how pharmaceutical and biotech companies can meet regulatory requirements for submission of these communications to the agency, the guidance also provides important insight into the agency’s view of these marketing avenues generally.
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