Vol. 14, Issue No. 2: February 2015 – EXECUTIVE SUMMARY

The Consumer Brief Summary FDA’s New Thinking Regarding Risk Communication
Fair BalanceNew evidence — and comments from the pharma industry — motivated the FDA to issue “revised draft guidance” on February 9, 2015, titled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.”

The new guidelines jettison the “traditional approach” to fulfilling the brief summary requirement and replaces it with what the FDA calls the “Consumer Brief Summary.”

What no one, including the FDA, is talking about, however, is the “fair balance” section of Rx drug ads.

This article summarizes the new guidelines and reviews the need for additional guidelines that specifically address the fair balance section of DTC print ads.

Topics (partial list):

  • Anatomy of a DTC Print Ad
  • Consumer Brief Summary
  • Facts Box
  • What About Fair Balance?
  • Consumer Attitudes Concerning Drug Ads
  • Fair Balance Warning Letters
  • “Reasonable Consumer” & Fair Balance
  • Should Digital Marketers Take Note?

Download the full article (PDF file) here:
www.pharma-mkting.com/news/pmnews1402-article01.pdf The Next FDA Commissioner Will Be… Industry Pundits Think It’s a Shoe-In. Do You?
FDA Commish ContendersIt’s official! Margaret (Peggy) Hamburg, MD, will step down as the commissioner of the U.S. Food and Drug Administration (FDA) this March. She has been on the job since March, 2009.

Since her announcement, there has been much praise and criticism of Hamburg’s job.

Hamburg wasn’t on anybody’s radar when Pharma Marketing News surveyed readers about who the next FDA Commissioner would be back in the fall of 2008. This time, there is only ONE person on the radar of most industry pundits: Robert Califf, M.D., Professor of Cardiology at the Duke University School of Medicine.

In a new survey, Pharma Marketing News asks your opinion about who should be the next FDA commissioner. The survey has been seeded with the candidates mentioned in this article. You can choose one of these or enter your own choice.

Topics (partial list):

  • Praise & Criticism
  • Who’s on the Industry Pundit Radar?
  • Who’s on Your Radar Screen?
  • Take the survey NOW!

Download the full article (PDF file) here:
www.pharma-mkting.com/news/pmnews1402-article02.pdf Patient Centricity, Transparency, & Pharma’s Reputation Getting Beyond Lip Service
Nobody Knows POLs OnlineA recent eyeforpharma “Industry Healthcheck” survey of 1600 pharma executives found that 85% of respondents agreed that patient-centricity is the best route to profitability and a key indicator of reputation among patients, although one respondent said there is a “huge gap and disconnect here between intent and action.”

Another “buzz” word/phrase popular in the pharmaceutical industry these days is “transparency.”

This article discusses real world examples of patient-centricity in pharmaceutical marketing and the need for more transparency in how pharmaceutical companies partner with patients online.

Topics (partial list):

  • Patient Centricity and Profitability
  • Defining Patient Centricity
  • Sanofi’s 3 Pillars of Patient Centricity
  • Transparency: Good in Theory, But Not in Practice
  • Can Big Data Analytics Help Pharma Deliver “Patient-Centric” Services?

Download the full article (PDF file) here: