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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!

    About This Blog

    • 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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    December 08, 2009

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    Comments

    locus

    I realize that you're miffed at the FDA for not changing regulations regarding internet advertising. However, your efforts to paint FDA as ignorant of the internet don't stand up to the evidence.

    If FDA is so ignorant of the internet, why have they published several rules and guidances related to electronic transmission of information to FDA via the internet? Surely an agency completely ignorant of the internet wouldn't be asking their stakeholders to USE it to communicate with them.

    It's my impression that FDA has not changed regulations regarding online advertisements because they feel that existing regulations are sufficient.

    In a response to an earlier post, I asked you why you think industry can't comply with existing regulations for their online advertisements (i.e. the "one-click" rule.) Another commenter echoed my reasoning. You agreed with me that the "one-click rule" isn't really a rule at all and actually DOES violate FDA regulations.

    Just because you and your clients are upset that the one-click rule isn't legal, doesn't mean that the FDA is ignorant of the internet.

    Mark Senak

    I'm not upset with the FDA about the one-click rule, I'm upset about the lack of thinking that is going into rule making. As to the FDA's understanding of the Internet, I stand by my conviction. Thanks for your comment.

    locus

    OK, then.

    Let's take my example (FDA allowing stakeholders to file electronically).

    Do you believe that FDA lacked "thinking" when they promulgated rules allowing for e-submission of information? I will note that they still allow paper filing (for those stakeholders truly ignorant of the internet). I will grant you that these changes could have been made SOONER, but they still happened.

    Your conviction (that FDA is ignorant of the Internet) still doesn't match the facts.

    Mark Senak

    Actually, it does. This is the 21st Century. The agency regulates as if it is the 1990s. And there is plenty of evidence to that fact. Electronic filing is not an example of cutting edge thinking. I'm not saying the FDA is across the board electronically ignorant. The widget during the peanut recall was very good. The regulation of communications with respect to getting medical product information has not been timely or effective.

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