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: August 2011
Weekly Roundup 8-19-11
Hello? Anyone out there? I send out a group email and get back scores of automated replies thanking me for my email and telling me when the recipient will be back in the office. I feel like the only person … Continue reading
Posted in Uncategorized, Weekly Roundup
1 Comment
Bills, Bills, Bills – An Update on Legislative Proposals
It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries. With Congress out on recess, it seemed like a good time to catch up on … Continue reading
Posted in Legislation, Proposed Legislation
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D-Day for Pharma and Facebook
It is another one of those questions – how did we get here? For months FDA’s DDMAC did not seem to understand the impact of social media, then asked for help understanding how to regulate it, then failed to produce … Continue reading
Posted in FDA Policy, New and Social Media, Podcast
3 Comments
Weekly Roundup 8-12-11
A break in the weather with cooling temps and a Congress out of session made Washington a more bearable place this week. Still, recovering from what has been the Bummer Summer may take a while and require some more salve. … Continue reading
Posted in Weekly Roundup
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Some Lessons Learned from 2011 NOV and Warning Letters
Earlier this week, we examined the Warning and NOV letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding … Continue reading
Posted in Warning Letters
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