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: September 2006
It’s Friday. Time to take off our boots, put our feet up and engage in the Weekly Roundup. One can tell in Washington, D.C. that the seasons are in flux – the front page of the Washington Post is once … Continue reading
When I began this blog back in February, I took a look at the increase in MedWatch alerts being issued by the FDA. Here is what I said: Since 2003, there has been a notable increase of 200% in output … Continue reading
The recent outbreak of e coli, being attributed to spinach, raises a number of questions, some of which are disturbing. (By the way, there have been updates on the spinach situation from the FDA.) What about microbes in our food? … Continue reading
Hold it! When Dr. Andrew C. von Eschenbach’s nomination was going before the Senate Committee, two Senators placed a hold on the nomination pending FDA promised action on the application for the RX to OTC switch of Plan B. They … Continue reading
This is the fourth in a series of four that has begun each week for the past month, exploring specific topics related to changing health policies and their impact on healthcare communications. There are two kinds of risks associated with … Continue reading