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: June 2007
Risky Business
Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing solely on communication of risk. Yesterday and today, the FDA … Continue reading
Posted in Risk Management
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New Media and Pharma – An Intermittent Series
Sorry there was not Weekly Roundup on Friday. A bus caught fire in my neighborhood and knocked out my Internet access. Go figure. Today’s posting is part of a series I’ve begun based on my belief that pharmaceutical companies are … Continue reading
Posted in Marketing
3 Comments
Alzheimer’s = An Insidious Disease State (AIDS)
In the Sunday New York Times Business Section, there was an article about Alzheimer’s research. As I read it, I was struck by the current state of research and the way it mimicked the AIDS epidemic during the late 1980s. … Continue reading
Posted in Research
4 Comments
The Congressional Hearing on Avandia
I attended the House Committee on Government Oversight and Government Reform hearing on the GlaxoSmithKline diabetes drug Avandia yesterday. It was crowded and heated, both literally and figuratively. If you are interested in watching the video of the Avandia hearing, … Continue reading
Posted in Drug Safety
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Risk Management Committee Announced; Congressional Hearing Tomorrow
Yesterday the FDA announced the formation of the Risk Communication Advisory Committee – a new 15 member committee solely dedicated to help FDA better understand the communication needs and priorities of the general public; advise FDA on the development of … Continue reading
Posted in Drug Safety
5 Comments