Vol. 15, Issue No. 5: December 2016 – EXECUTIVE SUMMARY Patients with Chronic Conditions Are OK With Off-Label Drug Promotion If FDA Allows It, Will Pharma Do It?
The FDA recently held a Part 15 hearing on regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”

In the notice for this meeting, FDA posed several questions for which it is seeking input at the hearing and afterward. Among these were two questions regarding off-label promotion targeted to patient and consumer audiences.

Results from three different surveys were presented at the hearing on November 9, 2016. Each survey addressed off-label direct-to-consumer (DTC) promotion of drugs by the pharmaceutical industry.

This article summarizes the results of these surveys.

Topics (partial list):

  • What Do Industry Insiders Think?
  • Does FDA Need Help?
  • A Mute Point If Payers Not On Board
  • inVibe Survey of Patients
  • Consumer Reports Survey
  • Will Pharma Do It?
  • Submit Your Comments

Download the full article (PDF file) here:

Industry vs. FDA Regarding DTC Animation Study Claims It’s Unnecessary & Unscientific
On February 23, 2016, FDA announced that it proposed to study “Animation in Direct-to-Consumer Advertising” (read “
Cute & Creepy DTC Drug Ad Mascots“).

AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals and other industry stakeholders have submitted comments to the FDA regarding this study.

This article summarizes several of these comments and FDA’s responses to them.

Topics (partial list):

  • Why Now?
  • No Practical Utility
  • Animation is Protected Speech
  • Eeriness of Certain Types of Animation
  • The Uncanny Valley Theory
  • What’s Animation Good For?
  • Another FDA Study: Character-Space-Limited Online Prescription Drug Communications

Download the full article (PDF file) here:

Pharma on Instagram How Top Drug Companies Use It Today & May Use It Tomorrow
Pharma on InstagramInstagram may become the social medium of choice for pharma marketers now that it has been purchased by Facebook and has added several new features that allow marketers to potentially thwart FDA regulations. These new features include Stories, disappearing video, and ephemeral messages.

This article reviews these new features and how they may be used by pharma marketers. Included is a review of Big Pharma Instagram accounts.

Topics (partial list):

  • Instagram vs. Facebook Demographics
  • Instagram Stories
  • Disappearing Videos and Ephemeral Messages
  • Verified Accounts
  • Comments Blocked?
  • A Gallery of Pharma Instagram Accounts

Download the full article (PDF file) here: