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 2011
For a while it seemed that FDA’s DDMAC was raising the enforcement bar. During the Bush years, enforcement plummeted from previous years dramatically. In 2008, the numbers seemed to rise, though in 2009, the numbers were actually a bit thrown … Continue reading
Every so often, I check in to see how the agency is faring when it comes to Advisory Committee transparency. The last time I did a chart like this several months ago, CDER and CBER figured in for having about … Continue reading
The nation has been served up a whole dish of bad theater from Washington this week. The play is bad. The actors are bad. And at least one of the leads can’t keep his chorus in line, however, if the … Continue reading
Last Friday, the FDA published notice about draft guidance on the issue of menu labeling in restaurants. The idea of labeling food choices in restaurants has long been a goal of those who advocate for greater education for consumers in … Continue reading