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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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: February 2008
Pursuant to the posting earlier this week which noted the rate of drug safety alerts out of the FDA, there also this week was a story published at CNNMoney.com that raises the very valid question whether or not patients and … Continue reading
In recent weeks, policymakers have turned up the heat on the FDA. First, Congressman Bart Stupak (D-MI) sent Dr. Andrew C. von Eschenbach a Valentine by demanding his resignation on February 14. Less than a week later, Congresswoman Rosa DeLauro … Continue reading
The Health Section of today’s Washington Post runs a story called "Why All the Drug Alerts? Step-Up Signals FDA Bid for Renewed Trust" which focuses on the uptick in FDA safety alerts about drugs. The uptick that the Post notes … Continue reading
Late last month, the National Health Policy Forum published a background paper called Pharmacogenomics: A Primer for Policymakers written by Leslie Tucker. It is a really excellent overview of the state of the state on pharmacogenomics and as the title … Continue reading