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Vol. 13, Issue No. 8: September 2014 - EXECUTIVE SUMMARY

Online e-Patient & Celebrity Patient Video Testimonials
Anecdotal Experience Marketing

Watch VideoPharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. This article asks the question: Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects?

Topics include (partial list):
  • Real Stories from Real Moms & Daughters
  • Symptoms & Undocumented Anecdotal Evidence
  • The Selling of ADHD and Ethics of Disease Awareness Advertising
  • Persuasive Celebrity Patient Video Testimonials
  • Overstating Efficacy
  • Declaration of Health Data Rights
Download the full text PDF file here:

More FDA Guidance on Distribution of Reprints
Presenting "New Risk Information" About Drugs

Benes-v-Speech TiltedFDA has long grappled with the thorny issue of the distribution of off-label drug information to physicians by the pharmaceutical industry and has published several draft, final, and revised final guidances related to that issue. The pharma industry and its allies have challenged the FDA's policies at every stage and fought legal battles in court to defend the right to distribute off-label, but scientifically sound drug information to physicians.

On June 6, 2014, FDA issued a THIRD guidance document regarding reprint distribution by pharmaceutic companies: "Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices." This new document describes FDA's recommendations for distributing reprints that convey "new risk information" for approved drugs.

Topics include (partial list):
  • Some Off-Label Litigation History
  • A String of Off-Label Guidances
  • WLF vs FDA
  • Criteria of Approved Off-Label Studies
  • Sidney Wolfe Cries Foul!
Download the full text PDF file here:

Drug Industry Rips Into FDA Over Social Media Guidelines
A Summary of Industry Comments Regarding Twitter & Google Adwords

Pharma Rips FDA a New OneEver since the epic #FAIL of FDA's July 10, 2014 webinar, which attempted to explain the agency's June 2014 social media guidelines, FDA has been the butt of jokes on pundit blogs (e.g., Pharma Marketing Blog) and also behind "closed doors" at industry conferences. In particular, the agency was criticized for not being technically savvy enough to understand the nuances of social media and search engine advertising.

Now, the industry's door is open thanks to comments recently submitted to the docket by industry groups and made public by the FDA. It's always interesting and educational to read these comments.

This article summarizes some of the main points made by PhRMA, Washington Legal Foundation (WLF), BIO, Medical Information Working Group (MIWG), Patient, Consumer, and Public Health Coalition, and several pharmaceutical companies, regarding FDA's Draft Guidance on using Internet and social media platforms with character space limitations.

Topics include (partial list):
  • FDA is Inconsistent, Says PhRMA
  • What's Good for the Goose (FDA) Should Be Good for the Gander (Pharma)
  • Fist Amendment Issues
  • FDA Rules are Anti-"Patient-Centric"
  • PhRMA Recommends the "One-Click Rule"
  • FDA's Poorly Defined New Media Landscape
Download the full text PDF file here:

Vol 13, #8 Contents

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