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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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    « AIDS Perspectives and Values | Main | D Day for Plan B? »

    August 18, 2006

    Weekly Roundup - 8/18/06

    J0399271_1 Well, partners - it is August and a lot of people are on vacation.  The Congress is out of town getting ready to get re-elected.  News is kind of slow out of Washington, D.C.

    Still, there is a little that happened this week while I was gone to the conference and here are some of the highlights, all rounded up for you.

    • PhRMA Report on the Value of Medicines - I have always thought that there is a huge communications gap when it comes to the matter of pricing and value between industry and consumers.  Companies talk value, consumers hear price.  No one seems to adequately bridge the gap, though some ads by a few pharma companies such as Novartis are great examples of what needs to be done.  However, PhRMA has issued a report on August 10 called Value of Medicines that supplies facts and figures from which communications professionals may wish to draw.
    • Approvable Letter for Lilly's Diabetic Retinopathy Drug - The FDA issued an approvable letter for ruboxistaurin mesylate (Arxxant(TM)) to Eli Lilly, which seems like one in an increasing stream of approvable letters sent out by the FDA recently.  It would be interesting to county the number of approvables over approvals and track them. 
    • Conservative Groups Call on White House for New FDA Commissioner Candidate - Symptomatic of the mess of Plan B that the Administration has gotten itself into, conservative groups are calling for the withdrawal of the von Eschenbach nomination. 
    • Battleground Plavix - Derek Howe at In the Pipeline did a great posting on the issue of generic Plavix. 
    • Last Word on the AIDS Conference - The takeaway lesson was that it would be a better world if Public Policy were trumped by Public Health, rather than the other way around. 

    Have a good weekend all and enjoy your vacations!

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