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http://www.sfubiz.ca/sma/wp-content/uploads/2013/04/DTC-Advertising-EN.sflb_. jpg. http://www.havidol.com/images/content_female.jpg. Direct-to-Consumer Pharmaceutical Marketing. Power Point by Joshua Friesen. http://pharmaregulations.files.wordpress.com/2010/10/wizardofid20522440207231.gif.
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http://www.sfubiz.ca/sma/wp-content/uploads/2013/04/DTC-Advertising-EN.sflb_.jpghttp://www.sfubiz.ca/sma/wp-content/uploads/2013/04/DTC-Advertising-EN.sflb_.jpg http://www.havidol.com/images/content_female.jpg Direct-to-Consumer Pharmaceutical Marketing Power Point by Joshua Friesen http://pharmaregulations.files.wordpress.com/2010/10/wizardofid20522440207231.gif
How can DTCPA be reformed so as to make it a beneficial practice for patients? But why does it need to be reformed? http://lifecarechiropractic.com/blog/wp-content/uploads/2012/09/vioxx-news-risk-of-having-heart-attack.png
FDA • Under staffed • Low funding • Complicated red tape http://www.thedailyrant.us/FDA.gif • FDA Regulation • Not be false or misleading • Present a “fair balance” of information • Include facts • Brief Summary
80 million patients prescribed world wide • $2.5 billion in sales per year • $100 million per year for advertising
>55,000 DEATHS http://www.nature.com/nature/journal/v436/n7050/images/436459a-i2.0.jpg http://www.healthnewsreview.org/wp-content/uploads/2012/02/27176791.jpg $321 million fine $4.85 billion payout to patients http://www.negotiationlawblog.com/uploads/image/vioxx%20settlement%20forum.jpg
Delay Advertising for New Products • Special symbol the first two years a drug is on the market • Delayed advertising until full drug safety profile is complete • Clinical trials are not designed to detect rare adverse effects • Blockbuster sellers are promoted early in their life
Ban Qualifying Language in DTC “Relapanaxis generally very well tolerated. Side effects tend to be mild and often go away in a short time. If side effects do occur they may include: nausea, upset stomach and diarrhea. It is important for you to know that few people were bothered enough by these side effects to stop taking Relapanax.”” “The most common side effects were headache (3%) and stomach ache (2%). Side effects generally did not last for a long time. All side effects disappeared within two weeks. Very few people (1%) stopped taking Relapanax due to these side effects.’’ http://www.hightowerlowdown.org/sites/hightowerlowdown.civicactions.net/files/2012-05_cartoon.jpg
Require Pre-clearance by the FDA • Mandatory preclearance procedure • Pay user fees • Increase resources of FDA • Regulation of online advertising http://stuartbramhall.files.wordpress.com/2014/01/big-pharma.jpg?w=614 • 50% though ads had to be approved by government • 43% though medication had to be completely safe to be advertised • 22% though that drugs known to have serious side effects couldn’t be advertised
Work Cited Davis, Joel. "The Effect of Qualifying Language on Perceptions of Drug Appeal, Drug Experience, and Estimates of Side-Effect Incidence in DTC Advertising." Journal of Health Communications. 12.1 (2007): 607- 622. Web. Johar, Kanika. "An Insider's Perspective: Defense of the Pharmaceutical Industry's MarketingPractices." Albany Law Review. 76.1 (2013): 299- 334. Web. Ventola, Lee. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic." P&T. 36.10 (2011): 669-84. Web.