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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Category Archives: Crisis Communications
Most Recent Heparin Hearing
Here is some footage of the Heparin meeting from this week where it was stated that the contamination of Heparin would appear intentional. Note: If you are a subscriber you will have to visit the Eye on FDA site to … Continue reading
Posted in Crisis Communications, Current Affairs
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When it All Goes Bad – Crisis Communications During Tough Times
We all have a bad time of it some of the time. Sometimes a confluence of events just throws us off our game. It isn’t just one bad piece of news, it is one after another and your very character … Continue reading
Posted in Crisis Communications, Pharma Industry Image
1 Comment
What is a Cholesterol Patient to Think?
I have very high cholesterol. I don’t even want to tell you how high. But I am also a bit of a statin-phobe. So when my doctor prescribed Vytorin, despite the extremely attractive direct-to-consumer advertising, I resisted. Vytorin is a … Continue reading
Posted in Crisis Communications
4 Comments
China in Need of Good Crisis Counseling
Every industry and every large company sooner or later faces a crisis. That crisis can be one of many forms. In the pharmaceutical and food industries, when a product is adulterated or causes harm, it is one of the most … Continue reading
Posted in Crisis Communications
2 Comments
Anatomy of a Consent Decree
Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA. The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree? … Continue reading