What You Need to Know to Keep Your Company’s Promotions Out of the Enforcement Spotlight


If you work in the pharmaceutical industry, you know that compliance with FDA rules on promotion is crucial to keeping your business in business. A mere allegation of non-compliance from FDA can have a profound impact on business, both directly (e.g., leading to a drop in sales or stock price) and indirectly (e.g., diverting precious resources to work on a response to the letter). In this article we explore recent FDA enforcement trends related to promotion of pharmaceutical products, and discuss the actions you can take to keep your promotion from getting your company the wrong kind of attention.
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Keeping Your Digital Advertising Compliant


Pharma’s history with digital media compliance is checkered, to say the least.
 
In 2009, the famous FDA paid search (referred to as “sponsored links”) warning letters were sent to 14 pharmaceutical companies. These 14 letters addressed the sponsored links for 48 individual brands and created enormous ripples in the industry.
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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 Although it contains nonbinding recommendations, this long-awaited draft Guidance provides pharmaceutical drug and biologics manufacturers with the FDA’s current thinking on how to fulfill their post-marketing regulatory requirements for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...]