Vol. 15, Issue No. 2: March 2016 – EXECUTIVE SUMMARY

TV DTC Advertising Is Not Dead Yet! But Lawmakers, Politicians, & FDA are Aiming for the Head
It's Alive!It doesn’t take a genius to realize that when FDA approves more drugs for marketing, more marketing happens. That may be just one reason why spending on direct-to-consumer (DTC) advertising in the U.S. totaled $5.2 billion in 2015 compared to $4.3 billion in 2014 — a 15% increase.

Meanwhile, there have been calls for a total ban of DTC advertising and presidential candidates and lawmakers are calling for the elimination of tax deductions for DTC advertising. And the FDA is planning a bevy of studies, which may lead to new guidelines.

Topics (partial list):

  • Figure: DTC Ad Spend v. Drug Approvals
  • Harvoni Case Study
  • Figure: Top 10 Advertised Drugs in 2015
  • Reports of TV’s Death are Greatly Exaggerated
  • CBS Is the Favorite DTC TV Network
  • Figure: TV Ad Spend by Top 20 Drugs in 2015 by Network
  • Is TV DTC Advertising Effective?
  • FDA Plans More DTC Studies
  • Consider a Partial DTC Ban

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Cute & Creepy DTC Drug Ad Mascots FDA Wants to Study How They Influence Consumers
Drug Ad Mascots“Advertisers use many techniques to increase consumer interest in their ads, including the use of animated spokes-characters [aka “mascots”],” notes the FDA in its Federal Register announcement. “It is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk, or otherwise hinders comprehension of drug risks and benefits,” added the FDA.

Brand name drug mascots not only appear in TV and print ads, they also are plastered all over patient education brochures and other marketing pieces that pharma sales reps hand out to physicians in their offices, as well as in booths at medical conventions, websites, and wherever else there are eyeballs!

This article features our all-time favorite drug ad mascots.

Featured Mascots (partial list):

  • Annoying Myrbetriq bladder character!
  • Detrol bathroom lady
  • Vesicare’s pipe people
  • Xifaxan’s Gutsy “bubble guy”
  • Mr. Mucus
  • Lamisil’s Digger the dermatophyte
  • “Sal” & “Marty” fish
  • Many more!

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Brave New World of Off-Label Marketing After the Fire Comes the Flood
Fire, Then FloodFDA’s authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court, FDA suffered another setback when it settled a case with Pacira Pharmaceuticals. In both cases, the plaintiffs argued that off-label marketing was protected free speech as long as the information was truthful and not misleading. While the FDA still insists it has the ultimate authority to decide what is and is not truthful, other entities have claimed a stake in the debate.

This article summarizes various scenarios for how the FDA, courts, and independent 3rd-parties may influence off-label drug promotion in the future.

Topics (partial list):

  • Avoiding Off-Label Chaos
  • External Entity Review
  • Judicial Off-Label Activism
  • Crying Fire!
  • Figure: Drug ADEs and Off-Label vs. On-Label Prescribing
  • The Coming Flood

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