About the AuthorMy 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.
My ProfileI 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 – 05-30-08
Well, it has been a mostly quiet week and the weather has been beautiful. The cherry blossoms are long gone, as are most of the lilacs. The hydrangeas are about to burst onto the scene in the Beltway and we … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 05-30-08
The Chilling Effect of Congressional Micromanagement on Drug Approvals
There is an excellent opinion piece in the Wall Street Journal today called Grassley’s War on Cancer Patients – which though the content is right on, the headline is a bit off. The point of the article is that Congress … Continue reading
Posted in Current Affairs 1 Comment
FTC Report on Generic Drug Deals
No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter. The subject of the report … Continue reading
Posted in Generic Drugs, Industry Image 1 Comment
Weekly Roundup – 05/23/08
It is the Friday before Memorial Day weekend, and it was a long time in coming as far as I’m concerned. I feel like the only person in Washington who came to work today. It is a beautiful day and … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 05/23/08
Progress in Cancer Drugs
CBS is running a series on the progress in the development of cancer drugs. Here is a clip from yesterday that discusses how the FDA manages the approval of cancer drugs:
Posted in Research 3 Comments