About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.Stay Connected
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I am an 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; and counselor in issues and crisis management. I am a 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 FleishmanHillard’s New York 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 FleishmanHillard or its clients.
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Monthly Archives: May 2008
Weekly Roundup – 05/16/08
Wow. Since the last Weekly Roundup we have had about 7 inches of rain inside the Beltway. That is about twice the average for the entire month of May. Needless to say, we are soggy in Foggy Bottom and elsewhere … Continue reading
Posted in Weekly Roundup
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Pharma Philanthropy
In the past month, I’ve written a good deal about the reforms that are taking shape here in Washington aimed at the industry and the FDA. One suggestion I had was for industry to start thinking ahead of the curve … Continue reading
Posted in Pharma Industry Image
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GAO Issues Report Citing FDA Slowdown on DTC Enforcement
Welcome to my 500th posting! Yesterday the Government Accountability Office released a report related to a topic often discussed in this space – the lack of FDA enforcement, specifically with regard to DTC – entitled "Trends in FDA’s Oversight of … Continue reading
Posted in DTC Advertising
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As Storm Clouds Gather….
There is little doubt that the pharmaceutical and biotechnology industries are in for a tough time in the coming months through the election cycle and beyond. The breadth and depth of investigations and inquiries coming from Capitol Hill, by members … Continue reading
Posted in Pharma Industry Image
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Weekly Roundup – 05/09/08
It is raining buckets – reportedly 3 inches since yesterday. The water table looks like its headed for restoration here. Lots of thunder and lightning. Flood AND tornado watch. Congress is skipping town to go home to Mom. Other … Continue reading
Posted in Weekly Roundup
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