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
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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.
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Monthly Archives: February 2008
Approvable Letter – Listing for 2007
I finally did it! I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me. I now have all of the approvable letters listed that I have seen occur. … Continue reading
Posted in Approvable Letters, FDA Policy
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New Public Relations and Public Affairs Challenge for FDA
Last evening, CBS 60 Minutes ran an investigative report rather dramatically entitled "One Thousand Lives a Month" about the drug Trasylol, manufactured by Bayer for the control of bleeding in patients undergoing surgery. The title of the piece is derived … Continue reading
Posted in FDA Image
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Fourth Quarter 2008 Warning Letters CDER
The pathetic rate of enforcement by CDER continues. I am so stymied why some smart reporter hasn’t posed the question – what is happening when the amount of PDUFA dollars and money in the federal budget for FDA goes up, … Continue reading
Posted in Warning Letters
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Weekly Roundup – 2/8/08
Inside the Beltway looking out, it was an exciting week. Super Tuesday helped narrow the field a bit and candidate fundraising has been quite interesting. Looking inside the Beltway, the Senate passed an economic stimulus package aimed at propping up … Continue reading
Posted in Weekly Roundup
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The Juggernaut of Importation
Two divergent sets of events conspire this week to create circumstances that make the prospect of drug importation more likely. First, the one we all have heard about all week – Super Tuesday. The undeniable front runners are Clinton, McCain … Continue reading
Posted in Drug Importation
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