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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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    « Class of One - Avoiding Warning Letters, Part II | Main | A Resource on Reimbursement - The Piper Report »

    February 24, 2006

    Alert on MedWatch Alerts!

    Are drugs suddenly riskier or is the FDA suddenly more vigilant? Questions about the agency's efficacy in protecting public health began to increase a few years back, when the ephedra issue presented itself and many critics thought that the agency moved so slowly to react that it looked like a follower, not a leader. One signal that the agency takes this criticism seriously and reacts by increasing visible vigilance is looking at the issuance of FDA Medwatch alerts.

    Since 2003, there has been a notable increase of 200% in output from the agency and nearly doubling the rate since last year.

    In 2003 there were 108 MedWatch alerts.

    In 2004 there were 160 MedWatch alerts.

    In 2005 there were 300 MedWatch alerts.

    Are drugs riskier or the agency more vigilant? Or is there another reason for this increase? Perhaps, but look for other visible surrogates that signal that the agency is appearing proactive rather than reactive.

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