Vol. 15, Issue No. 4: September 2016 – EXECUTIVE SUMMARY

Off-Label DTC Advertising Will FDA Be Forced to Allow It?
In what has been described as a “surprise move” the FDA recently published a Federal Register notice announcing that it will hold a 2-day public hearing November 9-10, 2016, to obtain input on issues related to off-label communications by manufacturers regarding FDA-regulated drugs and medical devices. FDA says it is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/ cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.”

What’s even more surprising is that FDA is asking questions about off-label direct-to-consumer (DTC) and direct-to-patient communications in addition to the typical questions about such promotions directed at physicians.

This article summarizes the First Amendment assault on FDA’s ability to regulate off-label communications.

Topics (partial list):

  • A Brief History of Off-Label Promotion
  • Chart: 25 Years of Pharma Criminal and Civil Penalties
  • First Amendment Challenges
  • Is the Battle Lost?
  • A Slippery Slope
  • Cancer Off-Label DTC May Be First Case?
  • Has It Already Happened?
  • Duke Chimes in on Off-Label Drug Promotion

Download the full article (PDF file) here:

Breakthrough Cancer Therapy DTC Boldly Emphasizing the Positive
As of July 18, 2016, the FDA has approved 46 breakthrough therapy designated products. According to the Friends of Cancer Research, nearly 75% (34) of these are for the treatment of cancer. One of these drugs — Bristol-Myers Squibb’s PD-1 inhibitor Opdivo — has been extensively covered in the media.

A recent NYT OpEd piece, for example, called the TV ads for Opdivo “utterly misleading and exploitive” and said that if BMS really wishes to thank patients who participated in the Opdivo drug trials, it should pull the ads because the drug “doesn’t work”.

This article explores the trend in direct-to-consumer (DTC) ads for “breakthrough” cancer therapies.

Topics (partial list):

  • What FDA Means by “Breakthrough Therapy”
  • Chart: Strong Opdivo Sales, For Now
  • Big, Bold DTC Ad
  • BMS’ View
  • Majority of Physicians Do Not Understand What Level of Evidence Supports FDA’s “Breakthrough” Therapy Designation
  • Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients
  • Impact on Sales
  • The Media’s Role

Download the full article (PDF file) here:

The Dark World of Disease Awareness Ads Pharma Marketers Use Scary Ads to Motivate Consumers
Pharmaguy was quoted in a recent Ad Age story (see
here) about the recent spate of scary drug ads seen on TV and in print.

“A trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine,” said Pharmaguy.

Lately many disease awareness ads have taken a distinctly dark approach and, in some cases, placed blame on parents and grandparents.

This article describes recent dark and ominous “disease awareness” ads, the goal of which is to instill fear in the viewing public and motivate them to see the doctor.

Topics (partial list):

  • Traditional Disease Awareness Marketing
  • No Risk, No Foul?
  • Stealthy Product Promotions
  • Going Dark & Scary
  • Gambling in the Social Media Age
  • Take a Lesson from Mylan
  • Is It Motivational?
  • Fear Sells More Than Logic
  • Slideshare Presentation

Download the full article (PDF file) here: