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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Legislative Tracking Tools
Monthly Archives: August 2007
New Drug Approval Rate – Not What it Used to Be
In news that doesn’t surprise most of us who have been watching FDA approvals, it would appear that someone has gone and counted up the approval rate and the rate of approvals for new drugs has, in fact, gone down. … Continue reading
Posted in FDA Policy 6 Comments
The FDA Bonus Issue – von Eshenbach’s Side
On August 2, the Washington Post carried an article about the FDA retention bonus program – "FDA’s Retention Bonuses Rise to the Top; Critics Say Money Goes to Managers, Not Scientists Coveted by Drug Firms" which was highly critical on … Continue reading
Posted in FDA Policy 1 Comment
Corporate Use of Blogging – Johnson & Johnson and the Lawsuit
As noted here previously, the Johnson and Johnson blog launched by the company – JNJ BTW – is an unusual and bold experiment in new media and pharma. Since its launch, the blog has covered a range of topics, trying … Continue reading
Posted in Pharma Industry Image 9 Comments
Does Silence Serve a Purpose?
Dr. von Eschenbach has been in charge of the FDA since late last year when he was confirmed. This year – 2007 – he has given but one speech on the FDA called the State of the FDA Address. In … Continue reading
Posted in FDA Image 2 Comments
Weekly Roundup – 8/10/07
Well, this has been a scorcher. Heat was unrelenting. And the week was hot here inside the Beltway as well as around most places in the country. Where it wasn’t hot, it rained torrents. Even the stock market had a … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 8/10/07