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US Direct-To-Consumer (DTC) Advertising in Pharmaceuticals Industry
Date:11/8/2011

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Advertisement 38

Vioxx' DTC Advertising Lands Merck into A Legal Tangle 39

Merck Settles Cases Against Vioxx Ad Campaign 39

Botox's Reminder Ads Highlight Regulatory Loopholes 39

Takeda's Disease-Awareness Ads for Gout - Clear and Crisp 40

AstraZeneca's Seroquel XR Ad Lacks the Fizz 40

Lunesta Ad Campaign - A Major Success 41

Gardasil DTC Ad Campaigns - Best Ads, Low Returns 41

7. ISSUES AND CHALLENGES IN DTC ADVERTISING 42

Impact of DTC Advertising on Clinical Care 42

DTCA Offers Valuable Medical Information to Public 42

Effect of DTC on Patient-Physician Communication Remains

Ambiguous 42

Appropriate Candidate Selection - A Key Requirement for DTC 43

DTC Spending Leads to Increase in Drug Prices - A False Notion 43

Table 8: Top Five Selling Drugs in the US and their DTC

Spending: 2007 43

Incremental Revenues Drive DTC Ad Spend 44

Potential Market and Competition, and Not DTC, Determine Drug

Prices 44

DTC Spillover into Canada - A Menace to Regulatory Regime 44

8. REGULATORY LANDSCAPE 45

US Regulations on DTC 45

FDA Categorization of DTC Pharmaceutical Advertising 45

A Historical Perspective of DTC Regulations 45

FDA Guidelines on DTC Print Advertisement of Drugs 46

FDA Guidelines on DTC Broadcast Advertisement of Drugs 46

Distinction Between FDA Regulations on DTC Drug and Device

Advertising 46

FDA's 1997-2004 Review on DTC Leads to Mixed Conclusions 47

Major Historical Developments in the US Legislations and

Regulations on Pharmaceutical Marketing and Advertising 48

FDA Proposes New Rules on Interpretation of Regulations on

Broadcast Ads 49

PhRMA Guiding Principles on DTC Advertising 49

Salient Guidelines for DTC Advertising Delineated by PhRMA 50

PhRMA's Revised Guidelines Invokes Mixed Responses 51

FDA
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