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: August 2006
Are Canadian Drugs Safe?
It looks like the same drug. It tastes like the same drug. How do I know if it is the same drug? As someone who does not have a strong opinion either way about the safety of drug importation, I … Continue reading
Posted in Drug Importation Comments Off on Are Canadian Drugs Safe?
Interagency Approach to Public Health
This is a little off beat, but what the heck – it is nearing the end of summer and news is slow. In reviewing the news, one sees that another study has demonstrated that Americans are fat. With as much … Continue reading
Posted in Current Affairs 1 Comment
Are FDA Advisory Committees a Rubber Stamp?
The drug approval process has long relied on advisory committees to provide input to the FDA regarding a candidate drug. For a long time, this process was somewhat mysterious. Over time, it has evolved to a highly transparent level. Meetings … Continue reading
Healthcare Communications and the Next Ten Years – Part 1 – RX to OTC Switches
Just as I offer Fridays as an opportunity to look back and digest what has happened during the week, I’ve decided to launch a new series, though abbreviated, that will be posted on Mondays. Entitled "Healthcare Communications and the Next … Continue reading
Posted in Healthcare Communications and the Next Ten Years - A Series Comments Off on Healthcare Communications and the Next Ten Years – Part 1 – RX to OTC Switches
Weekly Roundup – 8-25-06
Well partners, I’ve been rushing all morning trying to get out today’s Weekly Roundup and it has just been one of those days. Here I’ve been talking about how slow Washington is, but it seems like things in my office … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 8-25-06