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.
Posts by Date
Monthly Archives: April 2009
Last week, the New York Times carried an article "FDA Rules on Ads Sow Confusion as Applied to the Web" that addresses the call by the agency to issue 14 letters regarding 45 brands based on the lack of risk … Continue reading
Yesterday I had the good fortune to participate on a panel staged at the National DTC Perspectives Conference held here in Washington. The conference was impressive not only because of the size and scope of the turnout – hundreds … Continue reading
This week it was announced that a senior fellow from the office of Senator Edward Kennedy would be heading back to FDA as a senior counselor to Dr. Joshua Sharfstein where it is reported that the FDA Office of Legislative … Continue reading
The issuance of the 14 untitled letters by the FDA a week ago Friday has been very troubling on a number of circumstances. The agency accompanied the action that the letters were sent as part of "routine monitoring" which, unfortunately, … Continue reading