Vol. 9, No. 2: Feb 2010 – PREVIEW



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An EASY way to submit your comments to FDA about regulation of Internet & Social Media
An EASY way to submit your comments to FDA about regulation of Internet & Social Media

Preliminary results of this survey was presented at the November hearing. Tom Abrams, director of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), expressed thanks for presenting specific solutions that the FDA could consider when it creates new guidelines for the promotion of FDA-regulated products on the Internet and social media sites.

The goal of this survey is to obtain both quantitative and qualitative answers to the questions posed by the FDA. The entire survey responses database, including open-ended comments, will be submitted into the docket when the survey is completed just prior to the February 28, 2010 comment submission deadline. No personal information, however, will be included without your express permission.

Take the survey here.

You will be able to see a summary of up-to-date de-identified results upon completion of the survey.

Article Summaries

Up Front
Waiting for Goduidance

Waiting for GoduidanceIt seems like every pharmaceutical marketer is waiting for guidance from the FDA before they do more online marketing and especially more social media marketing.

It’s like Waiting for Godot — guidance may never come. What then? Or it could come. Then what?

Use of Behavioral Targeting by Pharma MarketersWhen Is It Appropriate?

Behavioral Targeting“The practice of advertising has clearly been revolutionized by the emergence of the Internet. Today, we can match the content of an ad to the interests of the consumer in ways undreamed of just a few short years ago,” said Nancy Hill, President & CEO, 4A’s.

This article summarizes the results of a survey designed to answer the questions:

  • Should the pharmaceutical industry adopt similar self-regulatory principles that were established by media and marketing trade associations to protect consumer privacy when employing behavioral targeting.
  • Should pharma marketers use behavioral targeting at all?
  • If they do use it, when is it appropriate?

Building the “New” Pharma Physician Marketing ModelMedTera’s HC Professional “Life Long Learning” Platform

Building BlocksPhysicians today are likely to receive drug information from a variety of sources and more often than not these sources are accessed via the Internet. Devices such as the iPhone — and soon the iPad — will make it even more convenient for physicians to receive online content.

In this new environment, eMarketing — also called non-personal promotion (NPP) — should be considered a tactic with unique advantages. “Brand teams can and should leverage the speed and efficiency of the ‘e’ channel to improve overall responsiveness and efficiency of their physician marketing programs,” said David S. Duplay, President of MedTera™, an integrated marketing solutions company. “What were now doing at MedTera is building an integrated marketing solutions company dedicated to improving education, promotion and communications in the healthcare, life science and pharmaceutical industry.”

This articles reviews MedTera’s branded integrated physician marketing solutions and a summary of research on how pharma marketing is changing and how brand teams see the mix of marketing tactics changing over the next several years.

Pharma and TwitterA Good Pair for Patient Support?

Twitter Patient SupportTwitter has often been hyped as a great way to support customers. The customers of pharma are physicians and patients. But pharma Twitter accounts offer very little in terms of patient support. Most are designed for corporate communications and unbranded marketing.

A branded, patient-focused Twitter account can be used in many ways to support patients. This article summarizes a survey that asked respondents to evaluate several ways in which Twitter could be used to improve patient support. Specifically, the survey asked how effective Twitter can be in carrying out each of the following patient support activities/communications:

  • Drug/device safety alerts (eg, drug recalls, medical device malfunctions, emerging safety issues)
  • Prescription management, including pharmacy refill reminders
  • Daily health tips from authoritative sources
  • Publishing disease-specific tips
  • Clinical trial awareness & recruitment
  • Enhancing health-related support groups (e.g. buddy-systems for depression)
  • Providing around-the-clock disease management
  • Patient-sharing of health-related experiences
  • Issuing dietary/lifestyle tips
  • Delivering adherence and compliance messages

Pharma’s Social Media Working GroupWho It Consists of, How It Formed, and What Its Objectives Are

SMWGWhile a few individuals and agencies have submitted comments to the FDA regarding regulation of pharma marketing on the Internet, to date only one adhoc group of pharmaceutical industry representatives have submitted comments. That group is the the Social Media Working Group (SMWG), which has come together to “facilitate discussions with the Division of Drug Marketing, Advertising and Communications, industry associations, and other pharmaceutical manufacturers on social media issues. The SMWG includes representatives from the following companies: Amgen, Inc.; AstraZeneca LP; Bristol-Myers Squibb; Millennium Pharmaceuticals, Inc.; and sanofi-aventis U.S.”

This article reviews the Who, What, and Why of this group based on a conversation with Craig M. Audet, Vice-President and Head of the US Regulatory Affairs Marketed Products Group at sanofi-aventis, Mark Gaydos, Senior Director, U.S. Regulatory Affairs Marketed Products at sanofi-aventis, and Cynthia Phillips, Sr Dir Labeling and Promotional Compliance at Millennium Pharmaceuticals. Also covered is an analysis of comments the SMWG submitted to the FDA on how pharmaceutical companies should handle off-label and adverse event posts made on social media sites owned or sponsored by them.