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 2010
MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!
"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading
Posted in DTC Advertising, FDA Policy, Warning Letters
3 Comments
Lettuce Beware! Communications on FDA and Food Safety – 2010 versus 2008
I ate a salad for lunch yesterday. Only today did I remember that I read in the Washington Post yesterday that there is a recall underway for bagged romaine lettuce and that the recall is expanding per the FDA. I … Continue reading
The Forest – A Litmus Test for Every Medical Product Marketer
Sometimes we look at individual regulatory actions and try and read the tea leaves. What does it say? What does it mean? What are the new parameters? But it also pays to look at the big picture. This may seem … Continue reading
Posted in Uncategorized
1 Comment
The Shelf Life of Messaging in a Social Media Environment
For some time now, the nature of communications has been changing as people move to new and emerging media to get and spread news. Prior to the Internet, messages were packed up and shipped out to us via broadcast and … Continue reading
Posted in Uncategorized
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