Vol. 8, No. 9: October 2009 – EXECUTIVE SUMMARY

Welcome to the OCTOBER 2009 issue of Pharma Marketing News. This is the Executive Summary version. See Article Summaries below.

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John Mack, Publisher & Editor
Pharma Marketing News

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FDA Social Media Questionnaire
Comment Upon Questions from FDA Regarding Social Media

The FDA is requesting the public to submit comments to a series of specific questions, which are included in this survey/comment form. This survey includes the following sections:

  1. Introduction
  2. Questions About You (affiliation, support of industry, etc.)
  3. Issue 1: Accountability
  4. Issue 2: Fulfilling Regulatory Requirements
  5. Issue 3: Posting Corrective Information
  6. Issue 4: Links
  7. Issue 5: Adverse Event Reporting
  8. Opt In Choice
  9. Thank You and Summary of Results

Many questions are pre-programmed with answers that you can select. As the survey progresses, other choices may be added to the list of answers. These additional choices will come from reviewing comments made to each question. It is important, therefore, that you include comments with any additional choices.

It is hoped that by participating in this survey you will learn more about the issues and use what you learn to submit official comments to the FDA.

Please take 2 minutes to answer this questionnaire regarding FDA’s regulation of Rx promotion via the Internet and social media.

Take the survey here.

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

Your comments areconfidential (anonymous) unless you specifically provide your contactinformation at the end of the survey and allow us to attribute commentsto you personally.

Article Summaries

Up Front
Fear and Loathing in Washington, DC

DC LoathingEven before the Federal Register Docket was open for comments, I sent a snail mail letter to FDA requesting a seat at the upcoming November public hearing on social media.

Not only will I have a seat, but I will make a presentation and have my 15 minutes of fame (literally!) in front of the DDMAC luminaries and the audience stuffed in the 350-seat meeting room at the National Transportation Safety Board (NTSB) Conference Center.

How did I manage that? Read on…

Download this article and read the details here:

Social Media Adverse Event Reporting Safe HarborsIt’s Time for FDA to Open Up the Internet to Rx Advertising Like It Did with TV!

Unsafe harborAdverse event (AE) monitoring and reporting are the two primary hurdles that pharmaceutical marketers must overcome before they can feel comfortable using the full two-way conversational features of the new Internet (ie, Web 2.0, aka “social media”).

This article presents ideas for regulatory “safe harbors” under which pharma companies would be relieved of the responsibility of monitoring social media for adverse events. Whether or not the FDA implements these or some other form of safe harbor is anybody’s guess. But if the drug industry really wants a safe harbor — and there is some question about that — this could be a start.

As background, the article also includes a detailed summary of responses to the survey “FDA Regulation of Drug & Device Promotion via the Internet & Social Media” regarding social media adverse event monitoring, processing, challenges, and uncertainties.

Topic headings include:

  • What Is an Adverse Event?
  • FDA Clarifies Pharma’s AE Reporting Responsibilities
  • “AEs” Within SM Discussions
  • The Adequate Provision Safe Harbor Precedent
  • AEs, Internet, & the FDA
  • Monitoring Adverse Events
  • Processing AEs from Social Media Sources
  • Challenges Handling Adverse Events Found on SM Sites
  • Uncertainties Regarding Adverse Events Found on SM Sites
  • Tit-for-Tat Tithe on Pharma Marketing
  • The Adverse Event Reporting Widget Safe Harbor
  • There’s Value in Adversity

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Pharmaceutical Market Access 2010Strategic Developments Impacting the US, EU, and Emerging Markets

Map ManIt’s no secret that the pharmaceutical and biotechnology industries are confronting significant short-term and long-term financial challenges that range from generic competition, upcoming patent expirations, and pending healthcare legislation and reforms in both the US and EU. These challenges are forcing the industry to “rethink” everything from R&D to Marketing.

“Future revenue growth in the US and EU will be limited,” said Stephen Potts, KantarHealth Regional Director, Asia Pacific, the Middle East and Africa, during a recent webinar entitled Pharmaceutical Market Access 2010. “Pharma and biotech companies are looking to emerging market opportunities in Brazil, Russia, India, and China (i.e., BRIC) to drive future business,” said Potts. “The EU is wrestling with the cost effectiveness of treatments and working through key changes in important regulatory processes. In addition, US healthcare reforms and pending legislation are pointing to universal coverage or the emergence of a ‘national plan’.”

What does this all mean for patients, physicians, payers, and pharmaceutical/ biotech manufacturers especially as payer actions and priorities converge across borders? Potts and his co-speakers — Lee Blansett, KantarHealth Senior Vice President, Oncology Market Access and Susanne Michel MD, KantarHealth Head of Global Market Access, Pricing and Reimbursement — addressed those questions during the webinar. This article presents a summary of the webinar.

Topic headings include:

  • The Shifting Center of World Markets
  • Access to Emerging Markets
  • Defining Ghostwriting
  • Trouble and Turmoil in the US Market
  • A Rise in Cost Consciousness
  • The UK Side of the Pond

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Risk Mitigation and Its Impact on Pharma MarketingAppropriate Use Benefits After Launch

ParagonRxDrug safety has always been a concern of FDA and drug manufacturers. Recently, however, FDA is paying even more attention to drug safety issues. The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require pharmaceutical companies to submit and implement a REMS — Risk Evaluation and Mitigation Strategy — if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks. About 33% of new molecular entities approved since FDAAA became effective on March 25, 2008 have required a REMS, and 75% of these required a Medication Guide, which contains information for patients on how to safely use a drug product, with a REMS assessment. So, REMS are becoming more common than in the past, although they are not yet “the rule.”

“Risk management, REMS, danger management of your product’s life cycle, whatever you call it, all are crucial to brand managers and marketing executives,” said Jeff Fetterman, President and CEO of ParagonRx (www.paragonrx.com), a Delaware-based company which specializes in programs for the appropriate use of medications.

This article summarizes Fetterman’s ideas about how to develop a REMS that can be a win-win-win situation for you, your product, and the patient.

Topic headings include:

  • REMS 101
  • Balancing Interests
  • REMS Program Impact on Intention to Prescribe
  • Alignment of Interests
  • ParagonRx’s Science-Based Methodology

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