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Feb29
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Yesterday, Medical Marketing and Media published an analysis in its e-newsletterpills.jpeg focusing on the FDA’s new draft guidance on off-label promotion.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“Sales reps could be effectively barred from circulating journal article reprints discussing off-label uses under FDA's draft guidance on ‘good reprint practices,’ and the agency considers the policy to be effective already, even in its draft form.”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. 

 

Feb21
Would Saving The Banana Give Genetically Modified Foods A Good Name?
The world is gaga over bananas.  Unfortunately, this unassuming, ubiquitous fruit is in extreme danger of going the way of the dodo – at last the variety that is shipped all over the world.  According to scientists, this fruit is... Continue Reading
Feb14
As Clinton Pushes For More Primary Debates, Critical Science Debate Ignored
With presidential hopeful Senator Barack Obama gathering a head of steam after the so-called Potomac Primaries, his rival Senator Hillary Clinton has been pushing for more debates between the two candidates.  Clinton has begun running an advertisement in Wisconsin hitting... Continue Reading
Feb12
Facebook’s Ills Highlight Balancing Act Between Commerce & Community
Yesterday, the New York Times published a story focusing on how hard it is to disengage from Facebook once one becomes a member.  Clearly, the story is having an impact because is currently most e-mailed, and blogged story on the... Continue Reading
Feb 7
Wanted: Public Education Campaign On The Dangers Of Mixing Pills
Yesterday, officials released details about the tragic and untimely death of actor Heath Ledger.  Despite speculation Ledger committed suicide or died from illegal drugs, it was revealed he was felled by a deadly combination of prescription medications.  According to a... Continue Reading
Feb 5
MicroYahoo! Vs, Google: The Implications For Health
The world’s atwitter at the prospect of Microsoft succeeding in its hostile takeover bid for Yahoo!  Since Microsoft announced its intentions last week, people have been wondering whether the deal makes sense.  Some think Microsoft is off its rocker.  In... Continue Reading
Feb 1
Genzyme Highlights Gaucher-Related Charitable Efforts Through Blog
In 2006, I wrote a blog post focusing on why I thought Genzyme should start a blog where it would discuss its charitable efforts related to Cerezyme, its expensive Gaucher treatment.  While I don’t think my post had much to... Continue Reading

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