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: February 2007
Today is President’s Day – a holiday for many, especially here in the Beltway where the Federal government will be closed, though the only way we will notice is the light traffic on the commute this morning… In light of … Continue reading
I am traveling outside the Beltway and having to meet real people (so you know I’m not in L.A!). It is a nice change, though I have to say, the nation is frigid! It was -3 degrees when I got … Continue reading
On December 11, following the vote to make Dr. Andrew C. von Eschenbach the FDA Commissioner, after years of "acting" status commissioners, I wrote in a posting: "…Dr. von Eschenbach should use the opportunity of the next few months to … Continue reading
The FDA announced the issuance of a new label for Ketek (telithromycin) that strips away two indications for use of the drug – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis – and retaining the sole remaining indication, … Continue reading
The Sunday New York Times Magazine carried an interview with FDA’s Commissioner, Dr. Andrew C. von Eschenbach that was noteworthy simply for the fact that the questions were more interesting than the answers. The questions, in some respects, said a … Continue reading