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: March 2011
BREAKING – Latest Statement from FDA on the Draft Guidance on the Internet and Social Media
In response to inquiry about the status of the FDA’s Draft Guidance on the Internet and Social Media, originally set for release by the end of 2010 and reset to aim for the first quarter of 2011, the agency responded … Continue reading
Posted in Uncategorized
11 Comments
FDA Funding – When the Audience Changes, the Message Must Change
On March 11, Dr. Margaret Hamburg presented testimony before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding funding for the FDA. Her remarks did a capable job of outlining what the FDA does and … Continue reading
Posted in FDA Image, Finance, Legislation
1 Comment
What the FDA Social Media Guidance Must Address
As March progresses, increasing numbers of social media observers, communications professionals and marketers of medical products are left wondering whether or not the FDA will produce the Draft Guidance on the Internet and Social Media by its (second) deadline of … Continue reading
Posted in FDA Policy, New and Social Media, Social Media
3 Comments
What Would it Take to Make a Great Pharma YouTube Channel?
As an industry, Pharma has not done a good job on YouTube. Most of the channels have malnourished content and appear as if they were an untended garden. Other industries have gone to great lengths to connect with their consumers … Continue reading
Posted in New and Social Media, Social Media
Comments Off on What Would it Take to Make a Great Pharma YouTube Channel?
Weekly Roundup 3/4/11
Well, the government didn’t shut down today. The way that it was covered in the media, the fact that Congress and the Administration averted a shut down by agreeing to a two-week Continuing Resolution, you would have thought they really … Continue reading
Posted in Uncategorized
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