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.
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Category Archives: Current Affairs
Gottlieb Set a New Bar – What Happens Now?
The news that Dr. Gottlieb was leaving his post as Commissioner of FDA took everyone by surprise. Perhaps another surprise to many was the skill and judgment he brought to the job when initially he faced many critics due to … Continue reading
Posted in Current Affairs, FDA Image
Tagged FDA, FDA Commissioner, Gottlieb
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When Public Policy and Medical Science Are Misaligned
Two announcements last week were in startling contrast. One was a scientific development that moves the needle forward, the other a policy announcement that tries to pull it back. The first development came from Google AI researchers and a published … Continue reading
Posted in Current Affairs
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New Directions for FDA, Part 1 – 21st Century Cures
One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading
Posted in Current Affairs, FDA Policy, Legislation
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Which Way on the Public Health Narrative on Zika?
Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, … Continue reading
Posted in Current Affairs
Tagged Public Health, Zika
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Serious Communications Planning Needed Now for Zika
Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad. As the … Continue reading
Posted in Crisis Communications, Current Affairs, Miscellaney
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