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      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

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    « Labor Day | Main | When Risk Management Manages Away Benefit »

    September 05, 2006

    Healthcare Communications and the Next Ten Years - Part 2 - DTC

    This is the second in a series that begins each week and on-going for a number of weeks, exploring specific topics related to changing health policies and their impact on healthcare communications.

    J0406754_1 One can instantly understand both the benefits and pitfalls of Direct-to-Consumer advertising simply by watching the evening network news.  If you don't feel sick by time it starts, you feel a little funny by end...

    The arguments for and against DTC have see-sawed over the years.  On the one hand, among other things, DTC educates consumers and perhaps motivates them to have conversations with their doctors they might not have otherwise had.  On the other hand, there are questions about the ability it has to create a market for conditions that otherwise did not really exist. 

    But there are proposals that would certainly change DTC, either directly or indirectly.  Consider one proposal that would ban DTC during a drug's first five years.  This weekend in the Washington Post, Marsha Cohen, a teacher food and drug law at the University of California's Hastings College of the Law in San Francisco published an op-ed writer proposing that drugs receive a license to market only for the first five years and then be re-reviewed for a permanent license.  It would stand to reason that DTC would not be an option during that preliminary license. 

    It is more than criticism of DTC that is driving the debate.  It is also a matter of cost.  No one outside of manufacturers themselves knows what percentage of a drug's price represents marketing.  Fine.  But as the government assumes a larger and larger role as payer, there is a greater chance that questions will turn into public policy.  Add to that the fact that there is a growing potential for political winds to shift in the U.S. very shortly, one can expect not only renewed vigor on this debate, but action in the form of legislation. 

    There sheer volume of the discussion around DTC almost guarantees some change.  This state of flux, and industry's awareness of it, is evident in the recent proposal by one company to increase PDUFA fees to cover an FDA review of all DTC ads, as neatly reported by John Mack in his Pharma Marketing Blog.  If the agency were to accept such an idea, it would only be a temporary fix.  It would not likely dissuade Congressional critics from looking at the cost of DTC versus the benefit. 

    What does a de-emphasis of DTC mean for healthcare communications?  Well, for one, the evening news would have to find new sponsors.  But the bigger impact would be on alternative strategies for product awareness and marketing - i.e., public relations.  That creates a challenge not only for industry, but for the communications consultants who serve them, to begin now to demonstrate strategic thinking to address this increasing potentiality. 

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    Comments

    Great post Mark. I also agree that public relations may take on an ever more important role in DTC marketing as DTC advertising comes under increasing scrutiny.

    However, with greater prominence comes the potential for increased scrutiny, especially of the cause alliances that help drive a number of PR educational campaigns (I'm talking about US marketing campaigns). PR pros must figure out how to manage these relations and self-regulate their activities to avoid criticism and censure.

    Fard

    Your thoughts on DTC triggered a quick analysis of Rx advertising in Reader's Digest. It's quite an eye opener. If DTC ads are curtailed, Reader's Digest and other publishers will have a lot to worry about. Namely, how to make up for the lost revenues. If I'm right, they will need to find two to three new advertisers for each pharma company loss.
    The details can be found on my blog at:
    http://laszloletter.typepad.com/the_laszlo_letter/2006/09/readers_digest_.html

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