About the Author
My 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.Stay Connected
My Profile
I 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
Twitter List
Legislative Tracking Tools
Monthly Archives: January 2008
McCain is the FrontRunner – The Tea Leaves for Pharma
Last night, John McCain won the Florida primary, clearly putting him in the status of front runner in the Republican Party. Hillary Clinton won Florida, even though that is an empty victory as far as delegates, she is trying to … Continue reading
Posted in Current Affairs
Comments Off on McCain is the FrontRunner – The Tea Leaves for Pharma
Does Cholesterol Matter? A Conversation with John Carey of BusinessWeek
Every time I hear the sound of my recorded voice, I am reminded why I write so much. I am still quite rough at the edges. Nevertheless, I’ve had the courage to do another podcast, this time with John Carey, … Continue reading
Weekly Roundup – 01/25/07
The Weekly Roundup is a bit more of a lonely trail without Cowboy Heath Ledger. Sorry to him go. Otherwise, it was a pretty busy week, with some bits of good news and quite a few bits of bad news. … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup – 01/25/07
If a Tree Falls in the Forest….
If a tree falls in the forest, and almost no one notices, did the tree almost not fall? Pharmaceutical Executive noticed, but I didn’t notice anyone else notice. I’m talking about the long-proposed user fee program for the FDA’s Division … Continue reading
Posted in DTC Advertising, FDA Policy, Marketing
2 Comments
Approval Outlook for 2008
As I’ve noted in recent posts, the situation in 2007 was pretty rough for new drug approvals. We saw an increase in approvable letters, and a decrease in the percentage of approval letters. Will it get better in 2008? I … Continue reading
Posted in FDA Policy
Comments Off on Approval Outlook for 2008