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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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    « FDA Announces Meeting on Stem Cells | Main | Iowa - What Does it Mean for Healthcare? »

    January 02, 2008

    Where the Candidates Stand - A Side by Side Comparison and Conclusion

    Happy New Year everyone! 

    And now that we are in 2008, the election cycle begins.  Iowa will kick off the season tomorrow. 

    J0384726Over the past few months, I have sought to shed some light on the positions of the candidates in relation to the issues most germane to this blog. 

    For example, all of the candidates want to cover the uninsured, but have some different ideas on how to do it.  On one end of the spectrum, there is Dennis Kucinich, who would abolish all insurance companies and essentially turn the entire system on its head.  On the other end of the spectrum, you have Ron Paul who does not seem to believe that the federal government has much of a role (including Medicare) and that the matter belongs to the states.  The rest of the candidates fall somewhere in between, with some favoring direct government involvement in setting up a system while others favor free market reforms. 

    All of the candidates also tend to agree that they want to bring in new technology and devices to manage information, cultivate more prevention programs and to improve the quality of healthcare.

    But what was perhaps most surprising was the fact that as much as the candidates differ on the details of these reforms, they were nearly all in favor of two changes that would have a hefty impact on the pharmaceutical market place - Medicare Part D reform and the importation of prescription drugs.  In other words, change with this election cycle is of course, inevitable, but it is also highly possible, if not probable, that candidates from both political parties will embrace these two reforms.  To me, that was news. 

    While the focus in healthcare reform is rightly placed on issues of access for the 47 million Americans who are uninsured, I have sought to examine lesser domains that would directly impact the marketplace for pharmaceuticals and biologics.

    While I examined five domains I will only do a side by side on three:

    Issue 1 - Importation - a hot topic, particularly among governors and those in border states, and one that does not have a clear party-line distinction. 

    Favoring importation:

    • Joe Biden
    • Hillary Clinton
    • Chris Dodd
    • John Edwards
    • Dennis Kucinich
    • John McCain
    • Barack Obama
    • Ron Paul
    • Bill Richardson

    Opposing Importation:

    • Rudolph Giuliani
    • Mike Huckabee
    • Fred Thompson

    No Clear Position on Importation:

    • Mitt Romney

    Issue 2 - Medicare Part D Reform -  a drive to change the Part D prescription drug program to allow for the government to negotiate prices:

    Favoring Medicare Part D Reform:

    • Joe Biden
    • Hillary Clinton
    • Chris Dodd
    • John Edwards
    • Dennis Kucinich
    • John McCain
    • Barack Obama
    • Ron Paul
    • Bill Richardson

    Opposing Medicare Part D Reform:

    • None

    No Clear Position on Medicare Part D Reform:

    • Rudolph Giuliani
    • Mike Huckabee
    • Mitt Romney
    • Fred Thompson

    Issue 3 - Marketing Practices - though largely a state issue, there are proposals at the federal level to restrict pharmaceutical marketing practices, such as curbing direct-to-consumer advertising. 

    Favoring More Restricted Marketing Practices:

    • Hillary Clinton
    • John Edwards

    Opposing More Restricted Marketing Practices:

    • Ron Paul - while not having a specific statement in this regard, such restrictions would run counter to his stated political philosophy on the role of the federal government.

    No Clear Position on More Restricted Marketing Practices:

    • Joe Biden
    • Chris Dodd
    • Rudolph Giuliani
    • Mike Huckabee
    • Dennis Kucinich - However, his philosophical outlook and his view of the pharmaceutical industry, he would probably favor restrictions.
    • John McCain
    • Barack Obama
    • Bill Richardson
    • Mitt Romney
    • Fred Thompson

    Inevitably, there is going to be a shakedown tomorrow and some of the candidates might not hang on until New Hampshire.  Clearly afterwards, there will be a winnowing of the herd.  As far as healthcare is concerned, though it is an area of great interest to voters, several of these candidates have not put much thought into their plans, or if they have, they have merely stated goals and failed to offer many specifics on the practical aspects of reform.  As the race progresses and positions become more clarified, Eye on FDA will provide updates. 

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