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 2006
Weekly Roundup – 6/23/06
I’m afraid the herd is quite thinned this week. In my mind, the big news of the week was from the Hill – the Kennedy/Enzi legislation which I posted about yesterday. There was not a lot going on at the … Continue reading
Posted in Weekly Roundup
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Upcoming Legislation
More on legislation, this time more expansive… The New York Times carried a report yesterday of legislation to be introduced by Senators Kennedy (D-Mass) and Enzi (R-Wyo) that from all appearances is sweeping in the nature of the reforms it … Continue reading
Posted in Pharma Industry Image, Proposed Legislation
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Proposed Legislation to Speed the Approval of Drugs
The current Congress has been a largely do-nothing body. It has enacted less legislation than most. They spent days last week debating gay marriage regarding an amendment everyone knew would fail while there were pressing matters demanding their attention. They … Continue reading
Posted in Proposed Legislation
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A New Day in Public Relations and Pharma Marketing
Related to yesterday’s posting, one of the consequences of the "new environment" of the post-COX-2s is that, because issues involving drug approval are getting more attention from both the public in general and policy makers in particular, the communications issues … Continue reading
What Does “Approvable” Mean?
There is a lot of word afoot that there are more approvable letters than there used to be. An approvable letter is one of 3 outcomes from the FDA review process, other than approved and not approvable. It can mean … Continue reading
Posted in FDA Policy
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