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: November 2007
The Iowa Caucuses are fast approaching and I want to get this series done beforehand. So today, we are looking at the healthcare plan of John Edwards. This plan is similar in nature in many ways to the Clinton plan … Continue reading
The FDA held an all day public meeting yesterday here in Washington to gain insight into the possibility of a Behind-the-Counter (BTC) designation for drugs. BTC would be non-prescription, but would require the intervention of a learned intermediary – i.e., … Continue reading
After wars in Iraq and Afghanistan and the issue of the increasingly faltering economy, healthcare tops the polls of issues of major concern to the electorate. Reflecting that, the Biden plan was four pages long and the Clinton plan a … Continue reading
Well, autumn is definitely here. The fireplaces have once again been lit. Thanksgiving is just around the corner. And this week, Congress discovered it had a backbone when it overrode a presidential veto for the first time. Anything can happen. … Continue reading
This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company. The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis. … Continue reading