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Legal Experts Say FDA Is Making Off-Label Promotion Tougher, Rather Than Easier

Yesterday, Medical Marketing and Media published an analysis in its e-newsletterpills.jpeg focusing on the FDA’s new draft guidance on off-label promotion.  The article was interesting because it suggests that the proposed regulations make off-label promotion harder rather than easier.  In addition, the FDA is already following the guidance, even though it is not in final form.  According to the article:

“Sales reps could be effectively barred from circulating journal article reprints discussing off-label uses under FDA's draft guidance on ‘good reprint practices,’ and the agency considers the policy to be effective already, even in its draft form.”

Most importantly, the FDA is helping to clarify a raft of regulations developed by OIG that made pharma companies very uncertain about where they stood.  With the new guidance, the FDA is trying to take get ahead of the off-label regulatory race.

While the debate over this guidance is certainly interesting, there needs to be a similar effort focusing on off-label promotion in the context of online marketing.  Within pharmaceutical companies there is a big debate about what is permissible – and not – on the Web (especially as it relates to social media).  Right now, the focus is on context – i.e., is my promotional message off-label if it appears near content we don’t control?  

This is a tough question to answer.  Unfortunately, the FDA has yet to comprehensively address it. 


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